SAN DIEGO, Nov. 11, 2021 (GLOBE NEWSWIRE) — Metacrine, Inc. (NASDAQ:MTCR), a clinical-stage biopharmaceutical company pioneering differentiated therapies for patients with gastrointestinal and liver diseases, today reported its third-quarter 2021 financial results.

“Our recent monotherapy and combination trial results demonstrate the strong therapeutic profile of our FXR program in non-alcoholic steatohepatitis (NASH), while also highlighting the potential of these agents as an important part of combination therapy,” said Preston Klassen, M.D., MHS, CEO, Metacrine. “Primarily because of the significant capital required to continue advancing our product candidates, we’ve halted future clinical development of our FXR program in NASH and will focus our financial resources and clinical development effort on moving MET642 into a Phase 2 trial in ulcerative colitis in the first half of 2022. In addition, we continue to advance our HSD discovery program as an exciting target in NASH and other liver diseases.”

Recent Clinical Development Milestones & Outlook

• A strategic re-prioritization of the Company’s clinical development programs – After a rigorous assessment of its NASH and inflammatory bowel disease programs, including the significant capital required to progress these large clinical development programs, the Company recently announced it is prioritizing its financial resources and clinical development effort to advance MET642 into a Phase 2 trial in ulcerative colitis in the first half of 2022. Metacrine has halted future development of its FXR program in NASH.
• MET642 Phase 2a monotherapy trial interim results – Metacrine reported interim results from its Phase 2a clinical trial evaluating the efficacy and safety of MET642 in approximately 60 NASH patients after 16 weeks of treatment. MET642 lowered liver fat content, with mean relative reductions of 26.9±27.8 percent in the 3 mg cohort and 9.3±55.8 percent in the 6 mg cohort, compared with 7.5±21.0 percent in the placebo arm. MET642 was generally well-tolerated, with no treatment-related serious adverse events (AEs). Mild-moderate pruritus was reported in one patient in the 3 mg cohort and one patient in the 6 mg cohort. No pruritus-related treatment discontinuations occurred. The Company expects to report completed topline study results in the first half of 2022.
• MET409 Phase 2a combination trial results – Metacrine reported topline results from its Phase 2a trial evaluating MET409 in combination with empagliflozin (Jardiance^®), a sodium-glucose cotransport-2 (SGLT2) inhibitor, in patients with type 2 diabetes and NASH. All regimens had favorable safety profiles and were generally well-tolerated, with no treatment-related serious AEs. Mild-moderate pruritus was reported in 0%-6% of patients across all groups. No pruritus-related treatment discontinuations occurred in any of the cohorts. Secondary assessment of liver fat content at 12 weeks indicated reduction in liver fat, as measured by MRI-PDFF, in both monotherapy arms and demonstrated additive effects in the combination regimen.

Third-Quarter 2021 Financial Results

• Cash Balance – Cash, cash equivalents and short-term investments were $61.7 million as of September 30, 2021.
• R&D Expenses – Research and development expenses were $14.1 million for the three months ended September 30, 2021, as compared to $6.2 million for the prior-year period. The increase was primarily driven by higher clinical development costs related to the advancement of the Company’s MET409 and MET642 programs.
• G&A Expenses – General and administrative expenses were $4.0 million for the three months ended September 30, 2021, as compared to $2.7 million for the same period in the prior year. The increase was attributable to higher employee-related costs and expenses associated with operating as a publicly traded company.
• Net Loss – Net loss was $18.3 million for the three months ended September 30, 2021, as compared to $9.1 million for prior-year quarter.

About Metacrine

Metacrine, Inc. is a clinical-stage biopharmaceutical company building a pipeline of differentiated therapies to treat gastrointestinal and liver diseases. Metacrine has developed a proprietary farnesoid X receptor (FXR) platform utilizing a unique chemical scaffold. To learn more, visit www.metacrine.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, statements about the design, progress, timing, scope and results of clinical trials; the anticipated timing of disclosure of results of clinical trials; plans for initiating future clinical trials and studies; statements regarding the therapeutic potential of MET409 and MET642; and plans for advancing the clinical development of Metacrine’s FXR program. Words such as “may,” “will,” “expect,” “plan,” “aim,” “projected,” “likely,” “anticipate,” “estimate,” “intend,” “potential,” “prepare,” “perceived,” “believes” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Metacrine’s expectations and assumptions that may never materialize or prove to be incorrect. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from those projected in any forward-looking statements due to numerous risks and uncertainties, including but not limited to: risks and uncertainties regarding regulatory approvals for MET409 or MET642; potential delays in initiating, enrolling or completing any clinical trials; potential adverse side effects or other safety risks associated with Metacrine’s product candidates; competition from third parties that are developing products for similar uses; and Metacrine’s ability to obtain, maintain and protect its intellectual property. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in Metacrine’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on August 12, 2021, and in Metacrine’s other filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except as required by law, Metacrine assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

Investor & Media Contact
Steve Kunszabo Metacrine, Inc.
+1 (858) 369-7892
skunszabo@metacrine.com

Validates therapeutic benefit of combination approaches for a large segment of NASH patients
–   Demonstrates additive efficacy results and favorable tolerability profile

SAN DIEGO, Nov. 02, 2021 (GLOBE NEWSWIRE) — Metacrine, Inc. (NASDAQ:MTCR), a clinical-stage biopharmaceutical company pioneering differentiated therapies for patients with gastrointestinal and liver diseases, today reported topline results from its Phase 2a trial evaluating MET409, a farnesoid X receptor (FXR) agonist, in combination with empagliflozin (Jardiance^®), a sodium-glucose cotransport-2 (SGLT2) inhibitor, in patients with type 2 diabetes and non-alcoholic steatohepatitis (NASH).

The Phase 2a study (NCT04702490) is a 12-week, randomized, placebo-controlled, multi-center trial that evaluated the safety, tolerability and pharmacological activity, as measured by reductions in liver fat content with magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF), of MET409 (50 mg) and empagliflozin (10 mg) versus individual treatments and placebo. A total of 132 patients were randomized (33 per treatment group).

All regimens had favorable safety profiles and were generally well-tolerated, with no treatment-related serious adverse events (AEs). Mild-moderate pruritus was reported in 0%-6% of patients across all groups. No pruritus-related treatment discontinuations occurred in any of the cohorts. LDL-cholesterol increases with MET409 were consistent with previous studies and were comparable alone or in combination with empagliflozin. Secondary assessment of liver fat content at 12 weeks indicated reduction in liver fat, as measured by MRI-PDFF, in both monotherapy arms and demonstrated additive effects in the combination regimen.

“NASH is closely linked to several co-morbidities, with an estimated 65% of type 2 diabetes patients also having NASH,” said Hubert C. Chen, M.D., chief medical officer, Metacrine. “These results showcase the multiple mechanisms that drive NASH and the promise of novel combination approaches in bringing new therapies to patients. We are pleased by the MET409 combination trial results, as this product candidate achieved improvements in liver fat both as a monotherapy and additively when combined with empagliflozin. Treating this large and important patient segment effectively will likely require combination therapies.”

MET409 Phase 2a Combination Trial Selected Data

MET409 Phase 2a Combination Trial Monotherapy Arm and MET642 Phase 2a Interim Results Comparison

Chen continued, “With the additional data from this study’s MET409 individual cohort, it has also become clear that MET409 and MET642 have comparable therapeutic profiles. Both compounds were developed from the same unique chemical scaffold, and these data along with the MET642 interim results we recently shared provide a comprehensive view of our FXR program and highlight the similarity of these two assets.”

As the Company previously stated, it has halted future development of its FXR program in NASH and is prioritizing its clinical development effort and resources to advance MET642 into a Phase 2 trial in inflammatory bowel disease (IBD).

About Metacrine

Metacrine, Inc. is a clinical-stage biopharmaceutical company building a pipeline of differentiated therapies to treat gastrointestinal and liver diseases. Metacrine has developed a proprietary farnesoid X receptor (FXR) platform utilizing a unique chemical scaffold. To learn more, visit www.metacrine.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, the potential for MET409 to be used in combination therapies; the potential for MET409 to be used in therapies for patients with both NASH and type 2 diabetes, the uncertainties inherent in clinical testing; future plans or expectations for MET409 or MET642, as well as the dosing, safety and tolerability of MET409 or MET642, plans for initiating future clinical trials and studies; statements regarding the therapeutic potential of MET409 or MET642. Words such as “could,” “may,” “will,” “expect,” “plan,” “aim,” “projected,” “likely,” ”anticipate,” “estimate,” “intend,” “potential,” “prepare,” “perceived,” “believes” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Metacrine’s expectations and assumptions that may never materialize or prove to be incorrect. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from those projected in any forward-looking statements due to numerous risks and uncertainties, including but not limited to: positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies, risks and uncertainties regarding regulatory approvals for MET409 or MET642; potential delays in initiating, enrolling or completing any clinical trials; potential adverse side effects or other safety risks associated with Metacrine’s product candidates; competition from third parties that are developing products for similar uses; and Metacrine’s ability to obtain, maintain and protect its intellectual property. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in Metacrine’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on August 12, 2021, and in Metacrine’s other filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except as required by law, Metacrine assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

Metacrine Strengthens Leadership Team with Key Appointments  

SAN DIEGO, September 2, 2020 — Metacrine, Inc., a clinical-stage biopharmaceutical company focused on discovering and developing differentiated therapies to treat patients with liver and gastrointestinal diseases, today announced the appointments of Catherine Lee as senior vice president, general counsel and Theresa Lowry as vice president, human resources.

“We are pleased to welcome Cathy and Theresa to the Metacrine team at this exciting time in the company’s evolution,” said Preston Klassen, M.D., MHS, president and chief executive officer of Metacrine. “Both Cathy and Theresa have extensive industry experience in their respective roles, and will be instrumental in our continued growth as an organization and the ongoing efforts to advance our FXR program for NASH in the clinic.”

Ms. Lee joins Metacrine from Omnione, Inc. where she served as senior vice president, general counsel. Prior to Omnione, she was most recently senior vice president, general counsel and corporate secretary of Senomyx, Inc. until its acquisition by Firmenich S.A. Before joining the biotechnology industry, Ms. Lee advised Outdoor Channel Holdings, Inc. for five years, serving most recently as its executive vice president, general counsel and corporate secretary. Prior to that, Ms. Lee held legal positions of increasing responsibility with Sempra Energy, Inc. over seven years, where she last served as corporate secretary and counsel. She began her career as an associate at Brobeck, Phleger & Harrison, LLP and Morrison & Foerster, LLP.

Ms. Lowry joins Metacrine from Arena Pharmaceuticals, Inc. where she served as head of global HR operations & total rewards. Prior to Arena, she was head of global HR operations & total rewards at ACADIA Pharmaceuticals, and before that, head of global rewards & HR operations at Ultragenyx Pharmaceuticals, Inc. Prior to that, Ms. Lowry was senior director, global total rewards & HR operations at ResMed Inc., and before that, director, human resources, global total rewards, talent acquisition & HRIS at Encore Capital Group, Inc. She began her career in HR as a consultant with Arthur Andersen and Ernst & Young.

About Metacrine

Metacrine is a clinical-stage biopharmaceutical company building a differentiated pipeline of therapies to treat liver and gastrointestinal (GI) diseases. The company’s most advanced programs, MET409 and MET642, target the farnesoid X receptor (FXR), which is central to modulating liver and GI diseases. Both MET409 and MET642 are currently being investigated in clinical trials as a potential new treatment for non-alcoholic steatohepatitis (NASH). For additional information, please visit www.metacrine.com.

Contact:
Caton Morris
THRUST Strategic Communications
336.403.0669
investors@metacrine.com

MET409 demonstrated notable improvements in decreased liver fat content and differentiated impacts on pruritus and LDL cholesterol after 12 weeks of treatment in NASH patients

SAN DIEGO, August 27, 2020 – Metacrine, Inc., a clinical-stage biotechnology company focused on discovering and developing differentiated therapies to treat liver and gastrointestinal (GI) diseases, announced positive, final results from its 12-week, randomized, placebo-controlled Phase 1b study of MET409, the company’s lead farnesoid X receptor (FXR) agonist, in patients with non-alcoholic steatohepatitis (NASH). These data are being presented in a late-breaking poster presentation¹ as part of the Digital International Liver Congress™ being held August 27-29, 2020.

In the Phase 1b proof-of-concept trial, 58 patients with NASH were randomized 1:1:1 to receive oral, once-daily MET409 at 80 mg or 50 mg, or to placebo. Study findings show that MET409 lowered liver fat content, with mean relative reductions of 55% in the 80 mg cohort and 38% in the 50 mg cohort, compared with 6% in the placebo cohort (P<0.001). Notably, MET409 achieved a 30% or greater relative liver fat reduction in 93% of patients (13/14) in the 80 mg cohort and 75% (12/16) in the 50 mg cohort, compared with 11% (2/18) in the placebo cohort (P<0.001). MET409 also normalized liver fat content to 5% or lower in 29% of patients (4/14) in the 80 mg cohort and 31% of patients (5/16) in the 50 mg cohort, compared with 0% in the placebo cohort (P<0.05).

“NASH is a highly prevalent, potentially life-threatening liver disease for which there are no approved treatments today,” said Eric J. Lawitz, M.D., vice president of scientific research and development at the Texas Liver Institute, clinical professor of medicine at the University of Texas Health San Antonio and a principal investigator of the study. “The magnitude of liver fat reduction observed after 12 weeks of MET409 treatment is highly encouraging and I look forward to further investigating MET409 as a potential new therapeutic approach to treating patients with NASH.”

In addition to liver fat reduction, there was a trend towards 30% or greater relative alanine aminotransferase (ALT) reduction with MET409 treatment: 50% (7/14) of patients in the 80 mg cohort and 31% (5/15) in the 50 mg cohort, versus 17% (3/18) with placebo (P>0.05). MET409 also showed a 30% or greater relative gamma-glutamyl transferase (GGT) reduction in 64% (9/14) of patients in the 80 mg cohort and 81% (13/16) in the 50 mg cohort, compared to 0% with placebo (P<0.0001). A transient, asymptomatic ALT and AST elevation was observed in a subset of patients at Week 8, without increased GGT or total bilirubin.

MET409 was generally well-tolerated in patients treated, with no treatment-related serious adverse events reported. Generalized pruritus (mild-moderate grade) was reported in 40% (8/20) of patients in the MET409 80 mg cohort and 16% (3/19) in the 50 mg cohort, which was determined to be related to treatment with MET409. Only two (10%) pruritus-related early discontinuations occurred, both at 80 mg. MET409 resulted in on-target increases in low-density lipoprotein cholesterol (LDL-C) of 23.7% with the 80 mg dose and 6.8% with the 50 mg dose, versus a reduction of 1.5% with placebo (P<0.05 for 80 mg only), from baseline to day 84.

“MET409 significantly decreased liver fat and improved liver enzymes in NASH patients, with encouraging safety and tolerability results, particularly showing a differentiated and favorable pruritus and LDL-C cholesterol profile at the 50 mg dose,” said Hubert C. Chen, M.D., chief medical officer of Metacrine. “These results provide the first clinical evidence that the therapeutic index of FXR agonists can be enhanced through structural optimization. The profile observed to date with MET409 relative to other treatments in development demonstrates the potential of our sustained, non-bile acid FXR agonist program for patients with NASH, and we look forward to advancing MET409 into our planned combination study next year.”

About Non-alcoholic Steatohepatitis (NASH)

Non-alcoholic steatohepatitis, or NASH, is a liver disease characterized by excess liver fat, inflammation and fibrosis. In 2015, there were an estimated 17 million people in the United States with NASH, which is expected to increase to an estimated 27 million people by 2030. Left untreated, patients’ disease may progress to liver failure, which is life-threatening without a successful liver transplant. NASH is expected to become the leading cause for liver transplants in the United States. Additionally, patients with NASH often present with metabolic disease and other co-morbidities, which is likely to require combination therapy. Currently, there are no approved therapies for NASH.

About Metacrine

Metacrine is a clinical-stage biopharmaceutical company building a differentiated pipeline of drugs to treat liver and gastrointestinal (GI) diseases. The company’s most advanced programs, MET409 and MET642, target the farnesoid X receptor (FXR), which is central to modulating liver and GI diseases. Both MET409 and MET642 are currently being investigated in clinical trials as a potential new treatment for non-alcoholic steatohepatitis (NASH). For additional information, please visit www.metacrine.com.

Contact:
Caton Morris
THRUST Strategic Communications
336.403.0669
investors@metacrine.com

SAN DIEGO, August 25, 2020 — Metacrine, Inc., a clinical-stage biopharmaceutical company focused on discovering and developing differentiated therapies to treat patients with liver and gastrointestinal diseases, today announced that the U.S. Food & Drug Administration (FDA) has granted Fast Track designation to MET409, the company’s lead farnesoid X receptor (FXR) agonist, for the treatment of non-alcoholic steatohepatitis (NASH).

“We are very pleased that MET409 has received this important regulatory designation,” said Preston Klassen, M.D., MHS, president and chief executive officer of Metacrine. “Fast Track designation underscores the significant need for treatments for people with NASH, who currently do not have any approved options, as well as MET409’s potential as a differentiated FXR agonist in NASH patients.”

Fast Track is a process designed to facilitate the development and expedite the review of drugs designed to treat serious diseases or conditions and that have the potential to fill an unmet medical need for such diseases or conditions. Through the Fast Track designation, the company may be eligible to submit sections of its New Drug Application on a rolling basis, and there are opportunities for more frequent interactions and written communications with the FDA around the drug’s development plan. A Fast Track-designated product may also be eligible for accelerated approval and priority review if the criteria for those programs are satisfied. This designation was granted to MET409 based on data from a completed Phase 1b study in NASH patients as well as preclinical studies.

About Non-alcoholic Steatohepatitis (NASH)
Non-alcoholic steatohepatitis, or NASH, is a liver disease characterized by excess liver fat, inflammation and fibrosis. In 2015, there were an estimated 17 million people in the United States with NASH, which is expected to increase to an estimated 27 million people by 2030. Left untreated, patients’ disease may progress to liver failure, which is life-threatening without a successful liver transplant. NASH is expected to become the leading cause for liver transplants in the United States. Additionally, patients with NASH often present with metabolic disease and other co-morbidities, which is likely to require combination therapy. Currently, there are no approved therapies for NASH.

About Metacrine
Metacrine is a clinical-stage biopharmaceutical company building a differentiated pipeline of therapies to treat liver and gastrointestinal (GI) diseases. The company’s most advanced programs, MET409 and MET642, target the farnesoid X receptor (FXR), which is central to modulating liver and GI diseases. Both MET409 and MET642 are currently being investigated in clinical trials as a potential new treatment for non-alcoholic steatohepatitis (NASH). For additional information, please visit www.metacrine.com.

Contact:
Caton Morris
THRUST Strategic Communications
336.403.0669
investors@metacrine.com

John McHutchison, AO, M.D., Appointed to Board of Directors Adding Significant Industry Experience and Drug Development Expertise

SAN DIEGO, Tuesday, June 9, 2020 — Metacrine, Inc., a clinical-stage biopharmaceutical company focused on discovering and developing best-in-class drugs to treat patients with liver and gastrointestinal diseases, today announced the appointment of Preston Klassen, M.D., MHS as President and Chief Executive Officer. Dr. Klassen joins Metacrine from Arena Pharmaceuticals, bringing more than 20 years of leadership experience in product development. In addition, John McHutchison, AO, M.D., Chief Executive Officer and President of Assembly Biosciences, has been appointed to the company’s Board of Directors.

“This is an exciting time for Metacrine as we advance the clinical development of both MET409 and MET642 for patients with non-alcoholic steatohepatitis, or NASH, for whom there are no approved therapies today,” said Dr. Klassen. “In the last several years, Metacrine has designed novel and proprietary FXR clinical product candidates that hold the potential to be best-in-class treatments for NASH and potential treatments for a variety of metabolic and inflammatory diseases. I am delighted to join this highly talented team to advance innovative drug candidates and improve the health of patients worldwide.”

Prior to Metacrine, Dr. Klassen was Executive Vice President, Head of Research and Development at Arena Pharmaceuticals, where he oversaw development of multiple early and late-stage clinical programs and contributed to its successful corporate transformation over the past few years. Before Arena, he served as Chief Medical Officer of Laboratoris Sanifit S.L., a biotechnology company, and prior to that was Executive Vice President, Head of Global Development at Orexigen Therapeutics, Inc. Earlier in his career, Dr. Klassen held several positions of increasing responsibility at Amgen Inc., including Therapeutic Area Head for Nephrology. Prior to joining Amgen, he was a faculty member in the Division of Nephrology at Duke University Medical Center. Dr. Klassen received his M.D. from the University of Nebraska College of Medicine and completed his residency in internal medicine, fellowship in nephrology, and masters in health sciences degree at Duke University.

“Preston’s extensive experience in advancing products through late-stage clinical development and commercialization will be invaluable to Metacrine, and we are thrilled to have him at the helm to lead the company through the next phase of its evolution,” said Richard Heyman, Ph.D., Chairman of the Metacrine Board of Directors. “We are also delighted to welcome John to the Board. He brings a track record of accomplishments in drug development and approvals, as well as deep knowledge of liver disease biology.”

Dr. Heyman continued, “We greatly appreciate the significant contributions by Ken Song over the last four years and look forward to his continued involvement as a senior advisor to Metacrine as we continue to advance our leading FXR agonist pipeline.”

Dr. McHutchison serves as Chief Executive Officer and President and Director of Assembly Biosciences, Inc. Previously, he was Chief Scientific Officer and Head of Research and Development at Gilead Sciences, Inc. Under his leadership, Gilead developed five medicines that are now prescribed around the world for the curative treatment of chronic hepatitis C and the treatment of chronic hepatitis B. Prior to Gilead, Dr. McHutchison held numerous positions at Duke University Medical Center, most recently as Associate Director of the Duke Clinical Research Institute. In June 2018, Dr. McHutchison was appointed an Officer of the Order of Australia in recognition of his distinguished service to medical research in gastroenterology and hepatology. Dr. McHutchison received undergraduate degrees in medicine and surgery from the University of Melbourne in Australia and completed his residency in internal medicine and fellowship in gastroenterology at the Royal Melbourne Hospital. He is a member of the Royal Australasian College of Physicians.

About Metacrine

Metacrine is a clinical-stage biopharmaceutical company building a potentially best-in-class pipeline of drugs to treat liver and gastrointestinal (GI) diseases. The company’s most advanced programs, MET409 and MET642, target the farnesoid X receptor (FXR), which is central to modulating liver and GI diseases. Both MET409 and MET642 are currently being investigated in clinical trials as a potential new treatment for non-alcoholic steatohepatitis (NASH). For additional information, please visit www.metacrine.com.

• Randomized, placebo-controlled 12-week study showed mean liver fat reduction of up to 55% with MET409
• 93% of patients showed liver fat reduction of at least 30% from baseline

SAN DIEGO, January 22, 2020 – Metacrine, Inc., a clinical-stage biotechnology company focused on building an innovative pipeline of best-in-class drugs to treat liver and gastrointestinal (GI) diseases, announced topline results from a 12-week, randomized, placebo- controlled study of MET409 in patients with non-alcoholic steatohepatitis (NASH). MET409 is a purposefully-designed farnesoid X receptor (FXR) agonist with two key features: non-bile acid chemical scaffold and sustained FXR activation.

MET409 was dosed orally once daily at 50 mg and 80 mg alongside placebo to evaluate safety, pharmacokinetics, pharmacodynamics and efficacy in 58 patients with NASH. Treatment with MET409 resulted in statistically significant reductions in relative mean liver fat content relative to placebo: 55% for 80 mg, 38% for 50 mg, and 6% for placebo. Approximately 93% and 75% of patients, with 80 mg and 50 mg treatment, respectively, had 30% or greater liver fat reduction from baseline. Significant reduction in alanine aminotransferase was observed at 80 mg, and meaningful response rates in other liver tests relative to placebo were also observed in both dose cohorts.

“The initial clinical results with Metacrine’s FXR program are impressive and unprecedented for the FXR class of drugs,” said Stephen A. Harrison, MD,.
“Based on publicly presented data, MET409 shows at least double the efficacy of liver fat reduction at 12 weeks, as compared to other FXR agonists in development.”

Overall, MET409 was safe and well tolerated with no treatment-related serious adverse events. Dose-dependent pruritus of moderate grade was seen in 5% and 10% in the 50 mg and 80 mg treated groups, respectively, which appears better than reported rates of moderate pruritus with other FXR drugs. Overall pruritus rates (10-35%) with MET409 were similar or better than that reported in clinical studies with other FXR drugs. Serum cholesterol changes with MET409 were consistent with on-target FXR activation.

“We are very encouraged with the statistically significant and dose-responsive efficacy seen with Research, founder of Summit Clinical Research and a Principal Investigator of the study just 12 weeks of treatment with MET409,” said Hubert C. Chen, MD, Chief Medical Officer of Metacrine. “Combined with a differentiated safety and tolerability profile, we believe our FXR program is well positioned to be a best-in-class monotherapy, as well as combination therapy for NASH patients.”

Additional details from this 12-week NASH study with MET409 will be presented at an upcoming conference.

About NASH

NASH is a liver disease that exists along a continuum of progressive liver deterioration and is characterized by fatty deposits, inflammation and cellular damage. NASH is expected to be the #1 reason for liver transplant in 2020. There are currently no therapies approved for NASH.

SAN DIEGO, November 18, 2019 – Metacrine, Inc., a clinical-stage biotechnology company focused on building an innovative pipeline of best-in-class drugs to treat liver and gastrointestinal (GI) diseases, today announced that Ken Song, M.D., President and CEO, will present at the Jefferies 2019 London Healthcare Conference on Wednesday, November 20, 2019 at 7:40 a.m. ET (12:40pm GMT).

About Metacrine

Metacrine is a clinical-stage biopharmaceutical company focused on building an innovative pipeline of best-in-class drugs to treat liver and gastrointestinal (GI) diseases. The most advanced program is focused on the farnesoid X receptor (FXR) an important drug target in multiple liver and GI diseases. Beyond the FXR program, a pipeline of novel drug candidates against other drug targets is being explored by taking advantage of internal drug discovery and development capabilities. Privately held Metacrine is headquartered in San Diego, California. For additional information, please visit www.metacrine.com.

Contacts:

Investor Inquiries
Trisha Millican
Chief Financial Officer
858.369.7800
tmillican@metacrine.com

SAN DIEGO, October 15, 2019 – Metacrine, Inc., a clinical-stage biotechnology company focused on building an innovative pipeline of best-in-class drugs to treat liver and gastrointestinal (GI) diseases, today announced that Hubert Chen, M.D., Chief Medical Officer, will present at the H.C. Wainwright 2019 NASH Investor Conference on Monday, October 21, 2019 at 2:20 p.m. EDT (11:20 a.m. PDT) in New York City.

About Metacrine

Metacrine is a clinical-stage biopharmaceutical company focused on building an innovative pipeline of best-in-class drugs to treat liver and gastrointestinal (GI) diseases. The most advanced program is focused on the farnesoid X receptor (FXR) an important drug target in multiple liver and GI diseases. Beyond the FXR program, a pipeline of novel drug candidates against other drug targets is being explored by taking advantage of internal drug discovery and development capabilities. Privately held Metacrine is headquartered in San Diego, California. For additional information, please visit www.metacrine.com.

Contacts:

Investor Inquiries
Trisha Millican
Chief Financial Officer
858.369.7800
tmillican@metacrine.com

SAN DIEGO, September 18, 2019 – Metacrine, Inc., a clinical-stage biotechnology company focused on building an innovative pipeline of best-in-class drugs to treat liver and gastrointestinal (GI) diseases, today announced it has entered into a loan and security agreement for up to $50 million with K2 HealthVentures (K2HV), a healthcare-focused specialty finance company.

“This financing bolsters our capital position and flexibility as we enter a period of accelerated activity around the advancement of our best-in-class FXR agonists for treating non-alcoholic steatohepatitis (NASH) and inflammatory bowel disease,” said Ken Song, Chief Executive Officer of Metacrine. “We chose to partner with K2HV because they are an experienced team of healthcare investment professionals who appreciate our desire to strategically deploy capital for clinical development as well as opportunistically expand our pipeline.”

The non-dilutive financing agreement provides Metacrine with $10 million of proceeds up front, and the option to draw additional tranches based on the achievement of certain milestones through 2020. Proceeds from the financing will be used to advance the company’s FXR agonist program and to support other general corporate activities.

“We are pleased to work with Metacrine to support the advancement of its pipeline, including its novel portfolio of FXR agonists, which have the potential to emerge as leading therapies for NASH and GI conditions,” said Anup Arora, Founding Managing Director and Chief Investment Officer of K2HV. “This transaction is aligned with our strategy of partnering with innovative life sciences and healthcare companies and offering flexible, customized financing solutions.”

About Metacrine

 Metacrine is a clinical-stage biopharmaceutical company focused on building an innovative pipeline of best-in-class drugs to treat liver and gastrointestinal (GI) diseases. The most advanced program is focused on the farnesoid X receptor (FXR) an important drug target in multiple liver and GI diseases. Beyond the FXR program, a pipeline of novel drug candidates against other drug targets is being explored by taking advantage of internal drug discovery and development capabilities. Privately held Metacrine is headquartered in San Diego, California. For additional information, please visit www.metacrine.com.

About K2 HealthVentures

K2 HealthVentures is an alternative investment firm focused on providing flexible, long-term financing solutions to innovative private and public companies in the life sciences and healthcare industries. The investment team is comprised of collaborative, experienced professionals with diverse backgrounds in finance and operations, as well as deep domain knowledge across various healthcare sectors. A uniquely flexible, permanent capital structure enables the firm to provide creative, adaptive financing solutions and meet the evolving capital needs of its portfolio companies as they grow. K2HV is driven by dual goals of Profit and Purpose – aiming to fuel the growth of innovative companies that will ultimately improve the lives of patients and giving a percentage of investment profits back to underserved areas in healthcare. www.k2hv.com

Contacts:

Metacrine
Inquiries:
Trisha Millican
Chief Financial Officer
858.369.7800
tmillican@metacrine.com

K2 HealthVentures
Inquiries:
Parag Shah
contact@k2hv.com

or

Media:
George MacDougall
gmacdougall@macbiocom.com