MTCR Metacrine Inc.

1.31
-0.04  -3%
Previous Close 1.35
Open 1.29
52 Week Low 1.11
52 Week High 11
Market Cap $35,782,064
Shares 27,314,553
Float 14,488,155
Enterprise Value $-14,089,354
Volume 389,928
Av. Daily Volume 1,702,991
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Upcoming Catalysts

Drug Stage Catalyst Date
MET642
Non-alcoholic steatohepatitis (NASH)
Phase 2a
Phase 2a
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Drug Pipeline

Drug Stage Notes
MET409 with JARDIANCE (empagliflozin)
Type 2 Diabetes and Nonalcoholic steatohepatitis (NASH)
Phase 2a
Phase 2a
Phase 2a top-line data released November 2, 2021. 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.

Latest News

  1. 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…

    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.





    Metacrine, Inc.
    Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss
    (In thousands)
            
     Three Months Ended Nine Months Ended
     September 30, September 30,
      2021   2020   2021   2020 
    Operating expenses:       
    Research and development$14,072  $6,217  $36,297  $19,973 
    General and administrative 4,007   2,693   11,695   6,087 
    Total operating expenses 18,079   8,910   47,992   26,060 
    Loss from operations (18,079)  (8,910)  (47,992)  (26,060)
    Total other income (expense) (249)  (144)  (689)  (428)
    Net loss$(18,328) $(9,054) $(48,681) $(26,488)







    Metacrine, Inc.
    Unaudited Condensed Consolidated Balance Sheets
    (In thousands)
        
     September 30, December 31,
      2021   2020 
    Assets   
    Current assets:   
    Cash, cash equivalents, and short-term investments$61,728  $96,176 
    Prepaid expenses and other current assets 3,852   5,847 
    Total current assets 65,580   102,023 
    Property and equipment, net 415   634 
    Operating lease right-of-use asset 1,077   1,579 
    Other non-current assets 438   - 
    Total assets$67,510  $104,236 
    Liabilities and Stockholders' Equity   
    Current liabilities:   
    Accounts payable$323  $334 
    Accrued and other current liabilities 9,574   3,692 
    Current portion of long-term debt 459   - 
    Total current liabilities 10,356   4,026 
    Long-term debt, net of debt discount 9,106   9,372 
    Other long-term liabilities 926   1,559 
    Stockholders' equity 47,122   89,279 
    Total liabilities and stockholders' equity$67,510  $104,236 



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

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  2. -   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…

    -   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

    EndpointPlaceboMET409



        50 mg    
    Empagliflozin



                  10 mg        
    MET409 50 mg +



    Empagliflozin 10 mg
    Mean relative liver fat change



    (±SD)
    3% ± 24%-16% ± 45%-16% ± 22%-28% ± 33%
    % of patients with >30%



    relative liver fat reduction
    3%50%23%47%
    Mean change in LDL-C0%12%-2%9%
    Overall pruritus rate0%6%0%3%
    Pruritus-related treatment



    discontinuation
    0%0%0%0%

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

    Endpoint



    (12 weeks for MET409, 16 weeks for MET642)
         MET409    



    50 mg
    MET642



           3 mg        
    Relative liver fat reduction



    (Placebo-corrected)
    19%19%
    % of patients with >30% relative liver fat



    reduction
    50%47%
    Mean change in LDL-C (Placebo-corrected)12%15%
    Overall pruritus rate6%5%
    Pruritus-related treatment discontinuation0%0%

    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.



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

    Primary Logo

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  3. SAN DIEGO, Oct. 21, 2021 (GLOBE NEWSWIRE) -- Metacrine, Inc. (NASDAQ:MTCR), a clinical-stage biopharmaceutical company pioneering differentiated therapies for patients with liver and gastrointestinal diseases, today reported interim results from a Phase 2a clinical trial evaluating the efficacy and safety of MET642, a farnesoid X receptor (FXR) agonist, in approximately 60 non-alcoholic steatohepatitis (NASH) patients after 16 weeks of treatment. The Company also announced it is prioritizing its clinical development effort and resources to advance MET642 into a Phase 2 trial in inflammatory bowel disease (IBD) in the first half of 2022.

    The Phase 2a trial (NCT04773964) is a 16-week, randomized, placebo-controlled, multi-center trial evaluating…

    SAN DIEGO, Oct. 21, 2021 (GLOBE NEWSWIRE) -- Metacrine, Inc. (NASDAQ:MTCR), a clinical-stage biopharmaceutical company pioneering differentiated therapies for patients with liver and gastrointestinal diseases, today reported interim results from a Phase 2a clinical trial evaluating the efficacy and safety of MET642, a farnesoid X receptor (FXR) agonist, in approximately 60 non-alcoholic steatohepatitis (NASH) patients after 16 weeks of treatment. The Company also announced it is prioritizing its clinical development effort and resources to advance MET642 into a Phase 2 trial in inflammatory bowel disease (IBD) in the first half of 2022.

    The Phase 2a trial (NCT04773964) is a 16-week, randomized, placebo-controlled, multi-center trial evaluating the safety, tolerability and pharmacological activity of MET642, as measured by reductions in liver fat content with magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF), changes in liver enzymes, low-density lipoprotein cholesterol (LDL-C) levels and incidence of pruritus, at 3 mg and 6 mg dose levels.

    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. Post-hoc comparative assessment of relative liver fat reduction in the interim cohort found the decrease with 3 mg to be statistically significant compared to placebo (p=0.006). MET642 achieved greater than 30 percent liver fat reduction in 47 percent of patients (8/17) in the 3 mg cohort and 35 percent (6/17) in the 6 mg cohort, compared with 12 percent (2/17) in the placebo arm.

    MET642 was generally well-tolerated, with no treatment-related serious adverse events (AEs). All treatment-related AEs were mild-moderate with no apparent dose relationship. 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. MET642 treatment resulted in on-target mean increases in LDL-C of 5 percent with the 3 mg dose and 19 percent with the 6 mg dose, versus a decline of 10 percent with placebo, from baseline to week 16.

    Mean Change (Baseline to Week 16)Placebo (N=20)3 mg (N=21)6 mg (N=20)
    Liver Fat Reduction (MRI-PDFF) % ±SD-7.5% ± 21.0%-26.9% ± 27.8%-9.3% ± 55.8%
    Median Liver Fat Reduction (MRI-PDFF) %-1.5%-28.6%-26.9%
    % of patients with >30% Liver Fat Reduction (MRI-PDFF)11.8%47.1%35.3%
    LDL-C %-10.5%4.5%19.4%
    Overall Pruritus Rate %10.0%5.0%5.0%
    Pruritus-Related Treatment Discontinuation %0.0%0.0%0.0%

    In addition, the Company is conducting an independent review of preliminary findings from a recently completed nine-month animal toxicology study for MET642, which may result in the need for an additional long-term animal toxicology study to support Phase 3 clinical trials in IBD. Metacrine expects the independent review to be completed before the end of 2021.

    "We are encouraged by the MET642 interim clinical trial results, as this product candidate demonstrated meaningful liver fat reduction at 3 mg and a potentially class-leading tolerability profile for the treatment of NASH at both 3 mg and 6 mg," said Preston Klassen, M.D., MHS, CEO, Metacrine. "In this small interim analysis, the 6 mg cohort displayed a non-normal distribution in liver fat changes, as evidenced by differences between the mean and median results. Further clarification of the impact on liver fat at the 6 mg dose will require examination of the complete trial data set, which is anticipated in the first half of 2022. NASH is a complex and chronic disease that we believe will likely require combination regimes to most effectively treat patients. MET642 can potentially serve as an important part of these novel combination approaches."

    Klassen continued, "After a rigorous assessment of our NASH and IBD programs, including the significant capital and resources required to progress these large clinical development programs, we have made the decision to focus Metacrine's clinical development effort and financial resources on moving MET642 into a Phase 2 trial in IBD in the first half of 2022 and to halt future development of the FXR program in NASH. This decision was influenced in part by a potential delay in confirming appropriate safety margins in our long-term toxicology work that would impact the timing of future NASH studies, but is unlikely to impact timelines for the IBD clinical program."

    Klassen concluded, "The rationale for FXR-based therapies in IBD holds great promise and is anchored on the potential to address multiple aspects of IBD pathogenesis without the immunosuppression inherent to other advanced-line therapies. FXR is highly expressed by intestinal epithelial cells and plays a key role in healthy intestinal function by maintaining the epithelial barrier, reducing bacterial translocation into the intestinal wall and regulating the innate immune response. Metacrine's preclinical studies supporting a role for FXR agonism in IBD are corroborated by significant evidence from the scientific literature. FXR therapy could potentially change the IBD treatment paradigm by bringing an oral, once-daily, well-tolerated and non-immunosuppressive medicine to patients. New approaches are clearly needed that expand therapeutic options for people living with IBD and we are excited to advance MET642 into clinical investigation in this important disease."

    About Metacrine

    Metacrine, Inc. is a clinical-stage biopharmaceutical company building a pipeline of differentiated therapies to treat liver and gastrointestinal diseases. Metacrine has developed a proprietary farnesoid X receptor (FXR) platform utilizing a unique chemical scaffold, which has demonstrated an improved therapeutic profile in clinical trials. 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, Metacrine's clinical development of MET642, the uncertainties inherent in clinical testing; future plans or expectations for MET642, as well as the dosing, safety and tolerability of MET642, plans for initiating future clinical trials and studies; statements regarding the therapeutic potential of MET642; the timing, outcome and potential impact of the independent review of the animal toxicology study of MET642; plans for advancing the clinical development of Metacrine's FXR and IBD programs; the potential leading nature of MET642 and Metacrine's FXR program; the potential for combination therapies to be used for NASH, the potential for its FXR product candidates to be used in combination therapies; and the potential for its FXR product candidates to be long-term therapies for NASH and IBD. 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 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

     



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    • Exceeded enrollment target of 180 total patients
    • Interim data from the first 60 patients expected early in the fourth quarter of 2021
    • Topline MET642 trial results from all patients are anticipated in the first half of 2022

    SAN DIEGO, Sept. 09, 2021 (GLOBE NEWSWIRE) -- Metacrine, Inc. (NASDAQ:MTCR), a clinical-stage biopharmaceutical company pioneering differentiated therapies for patients with liver and gastrointestinal diseases, today announced that it has completed enrollment for its Phase 2a trial evaluating MET642, an optimized farnesoid X receptor (FXR) agonist, in patients with non-alcoholic steatohepatitis (NASH). The Company plans to report interim data from the first 60 patients early in the fourth quarter of 2021.

    "As a potentially…

    • Exceeded enrollment target of 180 total patients
    • Interim data from the first 60 patients expected early in the fourth quarter of 2021
    • Topline MET642 trial results from all patients are anticipated in the first half of 2022

    SAN DIEGO, Sept. 09, 2021 (GLOBE NEWSWIRE) -- Metacrine, Inc. (NASDAQ:MTCR), a clinical-stage biopharmaceutical company pioneering differentiated therapies for patients with liver and gastrointestinal diseases, today announced that it has completed enrollment for its Phase 2a trial evaluating MET642, an optimized farnesoid X receptor (FXR) agonist, in patients with non-alcoholic steatohepatitis (NASH). The Company plans to report interim data from the first 60 patients early in the fourth quarter of 2021.

    "As a potentially best-in-class FXR agonist, MET642 has motivated investigators, and most importantly patients, to participate in our study despite a challenging Covid-19 environment," said Hubert C. Chen, M.D., chief medical officer, Metacrine. "Thanks to the diligent work of our clinical operations team and partners, we are just a few weeks away from announcing the MET642 interim results, which would enable initiation of a liver biopsy study in NASH and a proof-of-concept study in IBD in the first half of 2022."

    The Phase 2a study (NCT04773964) is a 16-week, randomized, placebo-controlled, multi-center trial evaluating the safety, tolerability and pharmacological activity of MET642, as measured by reductions in liver fat content with magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF), changes in liver enzymes, low-density lipoprotein cholesterol (LDL-C) levels and incidence of pruritis, at 3 mg and 6 mg dose levels.

    About Metacrine

    Metacrine, Inc. is a clinical-stage biopharmaceutical company building a pipeline of differentiated therapies to treat liver and gastrointestinal diseases. Metacrine has developed a proprietary farnesoid X receptor (FXR) platform utilizing a unique chemical scaffold, which has demonstrated an improved therapeutic profile in clinical trials. The Company's two product candidates, MET409 and MET642, are currently being investigated in clinical trials as potential new treatments for NASH. MET409 has completed a 12-week monotherapy trial in patients with NASH and is being evaluated in a 12-week combination trial with empagliflozin in patients with both NASH and type 2 diabetes. MET642 has completed a 14-day Phase 1 trial in healthy volunteers and is being evaluated in a 16-week monotherapy trial in patients with NASH. 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; the differentiated nature of Metacrine's FXR program; plans for advancing the clinical development of Metacrine's FXR program; the potential best-in-class nature of Metacrine's FXR program; and the potential for its FXR product candidates to be long-term therapies for NASH and IBD. 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
    

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    • Featuring KOL and management discussions on the science of FXR agonists and the Company's programs in NASH and IBD

    SAN DIEGO, Sept. 08, 2021 (GLOBE NEWSWIRE) -- Metacrine, Inc. (NASDAQ:MTCR), a clinical-stage biopharmaceutical company pioneering differentiated therapies for patients with liver and gastrointestinal diseases, today announced it will host a virtual R&D Day for analysts and investors on Wednesday, September 15, 2021 at 12:00 p.m. ET. The event will showcase Metacrine's programs in non-alcoholic steatohepatitis (NASH) and inflammatory bowel disease (IBD), as well as the introduction of a new discovery program.

    In addition to presentations by Metacrine's senior management team, the R&D Day will feature discussions from renowned…

    • Featuring KOL and management discussions on the science of FXR agonists and the Company's programs in NASH and IBD

    SAN DIEGO, Sept. 08, 2021 (GLOBE NEWSWIRE) -- Metacrine, Inc. (NASDAQ:MTCR), a clinical-stage biopharmaceutical company pioneering differentiated therapies for patients with liver and gastrointestinal diseases, today announced it will host a virtual R&D Day for analysts and investors on Wednesday, September 15, 2021 at 12:00 p.m. ET. The event will showcase Metacrine's programs in non-alcoholic steatohepatitis (NASH) and inflammatory bowel disease (IBD), as well as the introduction of a new discovery program.

    In addition to presentations by Metacrine's senior management team, the R&D Day will feature discussions from renowned key opinion leaders (KOLs) including:

    • Juan Pablo Frias, M.D. – Medical Director and Principal Investigator, National Research Institute
    • Jesus Rivera-Nieves, M.D. – Professor of Medicine/Gastroenterology, University of California, San Diego
    • Stefano Romeo, Ph.D. – Professor of Molecular and Clinical Medicine, Sahlgrenska Academy, University of Gothenburg

    The agenda for the Metacrine R&D Day is as follows:

    • Introduction from the CEO – Preston Klassen, M.D., MHS
    • The value of combination therapies in patients with both Type 2 Diabetes and NASH – Juan Pablo Frias, M.D.
    • Rationale for FXR Agonists in IBD – Jesus Rivera-Nieves, M.D.
    • HSD17B13 as a therapeutic target for liver disease – Stefano Romeo, Ph.D.
    • Closing remarks and final Q&A

    Registration for the event, as well as a live and archived webcast of the R&D Day, will be available in the Events section of the Company's website.

    About Metacrine

    Metacrine, Inc. is a clinical-stage biopharmaceutical company building a pipeline of differentiated therapies to treat liver and gastrointestinal diseases. Metacrine has developed a proprietary farnesoid X receptor (FXR) platform utilizing a unique chemical scaffold, which has demonstrated an improved therapeutic profile in clinical trials.   The Company's two product candidates, MET409 and MET642, are currently being investigated in clinical trials as potential new treatments for NASH.   MET409 has completed a 12-week monotherapy trial in patients with NASH and is being evaluated in a 12-week combination trial with empagliflozin in patients with both NASH and type 2 diabetes. MET642 has completed a 14-day Phase 1 trial in healthy volunteers and is being evaluated in a 16-week monotherapy trial in patients with NASH.   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 express or implied statements regarding our expectation of hosting an R&D Day. 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

     



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