Biomea Fusion, Inc. announced initial response data from the first two type 1 diabetes patients treated with BMF-219 in the ongoing Phase II study (COVALENT-112). COVALENT-112 is a randomized, placebo-controlled, double-blind Phase II study (n=150) designed to examine the safety, efficacy, and durability of BMF-219 in adults diagnosed with type 1 diabetes within 3 years at two oral dose levels, 100 mg and 200 mg, for 12 weeks of treatment followed by a 40 week off-treatment period. The trial includes an open label portion for adults with type 1 diabetes up to 15 years since diagnosis.

The open label portion (n=40) will also examine the safety, efficacy, and durability of BMF-219 at two oral dose levels, 100 mg and 200 mg, for 12 weeks of treatment followed by a 40 week off-treatment period. are highlighting initial response data from a data cut-off of March 7, 2024 from first two patients with Stage 3 type 1 diabetes who have received BMF-219 in the open-label portion of COVALENT-112 Case Study Patient 1 Highlights A 58-year-old, diagnosed with type 1 diabetes 3 years ago BMF-219 200 mg once-daily Week 4: Fasting C-peptide increased by 57% compared to Baseline (study Day 1). During a mixed-meal tolerance test the C-Peptide Index increased by 12%.

The C-peptide index is the ratio of serum C-peptide to plasma glucose levels and is used to evaluate ß-cell function Week 8: Fasting C-peptide increased by 80% compared to Baseline. During a MMTT, C-peptide increased up to 200%. The C-Peptide Index (AUC) increased by 40% compared to Baseline Data on any changes in daily insulin usage are pending Case Study Patient 2 Highlights A 24-year-old, diagnosed with type 1 diabetes 7 years ago BMF-219 100 mg once-daily Week 4: Fasting C-peptide increased by 16% compared to Baseline.

During a MMTT the C-peptide Index (AUC) increased by 30% Patient had a near-normal glucose response during the MMTT without receiving any meal-time insulin Patient had a reduction in daily insulin usage during the first four weeks of the study.