Biomea Fusion Q2 update

 DIABETES

COVALENT-111 (BMF-219 for Type 2 Diabetes) & COVALENT-112 (BMF-219 for Type 1 Diabetes)

• On June 6, 2024, company announced it received notice from FDA that a full clinical hold has been placed on Biomea’s ongoing Phase I/II clinical trials of the company’s investigational covalent menin inhibitor BMF-219 in type 2 and type 1 diabetes (COVALENT-111 and COVALENT-112), respectively. In its communication, FDA noted deficiencies based on the level of possible drug-induced hepatotoxicity observed in the completed dose escalation phase of COVALENT-111.
• Initial data reported from the first two type 1 diabetes patients dosed with BMF-219 in COVALENT-112 demonstrated early signs of clinical activity with improved measures of beta-cell function after initial treatment with BMF-219. BMF-219 has been generally well tolerated by both patients.

Anticipated Milestones:

• Topline Week 26 data readout of Phase 2b with approximately 195 patients of COVALENT-111 expected for Q4 2024.
• Topline data readout of Phase 2a of COVALENT-112 with approximately 20 patients expected for Q4 2024.

OBESITY

Third Program (Oral, Small Molecule, GLP-1R Agonist)

Anticipated Milestones:

• Announce a third development candidate, a potent, selective, GLP-1 receptor agonist, expected in Q3 2024.
  

ONCOLOGY

COVALENT-101 (BMF-219 for Liquid Tumors)

Anticipated Milestones:

• Complete dose escalation portion of COVALENT-101 expected by year end 2024.
  (Two cohorts, CLL and DLBCL of COVALENT-101 have been discontinued due to insufficient enrollment.)
  

COVALENT-102 (BMF-219 for Solid Tumors)

Anticipated Milestones:

• Complete dose escalation portion of COVALENT-102 expected by year end 2024.
  

COVALENT-103 (BMF-500 for Acute Leukemias)

Anticipated Milestones:

• Complete dose escalation portion of COVALENT-103 expected by year end 2024.

https://www.globenewswire.com/news-release/2024/07/31/2922242/0/en/Biomea-Fusion-Reports-Second-Quarter-2024-Financial-Results-and-Corporate-Highlights.html