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Thursday, December 7, 2023

Biomea Fusion Data from Ongoing Phase II Study of BMF-219 in Adults with Type 2 Diabetes

 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.

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