- Biomea Fusion, Inc. reported **positive 52-week results** from its Phase II COVALENT-111 study for icovamenib in Type 2 diabetes on **October 6, 2025**.  **[1840439_0001193125-25-231903_d79150d8k.htm:1]** 
- The study demonstrated a **durable HbA1c reduction of 1.2% (p=0.01)** sustained through Week 52 in severe insulin-deficient patients who received 12 weeks of treatment, with the strongest arm achieving a **1.5% reduction (p=0.01)**.  **[1840439_0001193125-25-231903_d79150d8k.htm:1]** 
- Icovamenib also showed a **1.3% reduction in HbA1c (p=0.05)** in patients receiving GLP-1-based therapy, while maintaining a **favorable safety profile** with no treatment-related serious adverse events.  **[1840439_0001193125-25-231903_d79150d8k.htm:1]** 
- The company plans to initiate a Phase IIb trial (COVALENT-211) and a Phase II trial (COVALENT-212) in Type 2 diabetes patients in the **fourth quarter of 2025**.  **[1840439_0001193125-25-231903_d79150d8k.htm:1]**

Biomea Fusion Reports Positive 52-Week Results from COVALENT-111 Study

- Biomea Fusion announced **positive 52-week results** from its Phase II COVALENT-111 study evaluating **icovamenib** in patients with Type 2 Diabetes (T2D).  **[1840439_d5b3734eb55947a8a76bd0b4a8f72bf2_1]** 
- Icovamenib demonstrated a **sustained treatment benefit** at Week 52 in severe insulin-deficient diabetes patients, showing a **1.8% placebo adjusted mean reduction in HbA1c**.  **[1840439_d5b3734eb55947a8a76bd0b4a8f72bf2_0]** 
- Type 2 diabetes patients on GLP-1-based therapy who were failing to achieve their target HbA1c also showed a **clinically meaningful response**, with a **1.8% mean placebo adjusted HbA1c reduction** at Week 52 after only 12 weeks of treatment.  **[1840439_d5b3734eb55947a8a76bd0b4a8f72bf2_0]** 
- Icovamenib was **generally well tolerated** and maintained a **favorable safety and tolerability profile** throughout the 52-week observation period.  **[1840439_d5b3734eb55947a8a76bd0b4a8f72bf2_0]** **[1840439_d5b3734eb55947a8a76bd0b4a8f72bf2_2]** 
- **Phase II trials** (COVALENT-211 and COVALENT-212) for icovamenib in these patient populations are expected to begin in the **fourth quarter of 2025**.  **[1840439_d5b3734eb55947a8a76bd0b4a8f72bf2_0]** **[1840439_d5b3734eb55947a8a76bd0b4a8f72bf2_2]**

Biomea Fusion (BMEA)