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home / articles / BMEA - Biomea Fusion to Present Long-Term Follow-Up Data from Ongoing Phase II Study (COVALENT-111) of BMF-219 in Adults with Type 2 Diabetes and Results from Ex-Vivo Human Islet Experiments at the World Congress Insulin Resistance Diabetes & Cardiovascular Dis


BMEA - Biomea Fusion to Present Long-Term Follow-Up Data from Ongoing Phase II Study (COVALENT-111) of BMF-219 in Adults with Type 2 Diabetes and Results from Ex-Vivo Human Islet Experiments at the World Congress Insulin Resistance Diabetes & Cardiovascular Dis

  • BMF-219 is an investigational novel covalent menin inhibitor developed to regenerate insulin-producing beta cells with the aim to cure diabetes

    • In a poster presentation on Thursday, Dec. 7th at 6:30pm and an oral presentation on Friday, Dec. 8th at 7:30pm, Biomea to present new preclinical and clinical data highlighting:
      • A sustained HbA1C reduction of ?0.5% and ?1.0% in 40% and 20% of patients, respectively, 22 weeks after the last dose from the 4-week BMF-219 treatment period from the initial two 100mg QD dose cohorts investigated in COVALENT-111
      • BMF-219 was generally well tolerated; there were no dose reductions, dose discontinuations, or severe or serious adverse events
      • BMF-219 displayed glucose-controlled beta cell proliferation in a preclinical ex-vivo human islet model, supported by on-target cell-cycle gene expression changes
      • The poster will present additional data on the reduction of A1c at Week 26, twenty-two weeks after last dose, change in C-peptide and Homa-B compared to baseline
    • Biomea will kick-off the WCIRDC meeting by hosting a congress symposium titled, "BMF-219: An oral menin inhibitor in clinical development as a short-term treatment to address the root cause of diabetes, beta-cell dysfunction" on Thursday, December 7th at 7am PST.
    • COVALENT-111 trial is ongoing and currently enrolling the expansion phase of the study. The company will share topline data from the escalation portion of COVALENT-111 at the conclusion of WCIRDC.

    REDWOOD CITY, Calif., Dec. 07, 2023 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea") (NASDAQ:BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, today announced the full abstract, titled "BMF-219: A novel therapeutic agent to reestablish functional beta cells and provide long-term glycemic control", will be presented during the Abstract Oral Presentation Session as well as the Poster Session of the 21st World Congress Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRDC) taking place in Los Angeles, California on December 7-9, 2023.

    "We are honored to be selected as one of the six oral presentations by the WCIRDC Abstract Committee. We've seen truly promising data to date with BMF-219's novel proposed mechanism of action which is designed to address an underlying cause of type 2 diabetes – the loss of healthy, insulin-producing beta cells. BMF-219 is the first investigational agent to show durable glycemic control during off-treatment period after four weeks of dosing. Together with the evidence in ex-vivo human islet experiments, we believe these data validate the proposed mechanism of action for BMF-219 – disruption of menin drives beta cell-specific proliferation. These data also further support the potential for BMF-219 as a disease modifying agent in type 2 diabetes. We are excited about these early findings and look forward to presenting the data during the conference," said Juan Pablo Frias, M.D., Chief Medical Officer at Biomea.

    Details for the abstract are listed below and can be viewed online on the WCIRDC conference website. Presentation slides from the Breakfast Symposium will be made available after the event on Biomea's website. There will be a replay of the presentation once available through the WCIRDC.

    Abstract #0088

    BMF-219: A novel therapeutic agent to reestablish functional beta cells and provide long-term glycemic control

    Presentation Time:

    Poster Presentation: ...

    Full story available on Benzinga.com

  • Stock Information

    Company Name: Biomea Fusion Inc.
    Stock Symbol: BMEA
    Market: NASDAQ
    Website: biomeafusion.com

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