Biomea Fusion (BMEA) 7th Annual Evercore ISI HealthCONx Healthcare Conference summary

2024 highlights and clinical progress

• Advanced from animal studies to human clinical trials, focusing on beta cell proliferation for diabetes treatment.

• Recent data show greatest benefit in insulin-deficient or beta cell-deficient patients, with ongoing efforts to identify optimal patient subgroups and dosing.

• Upcoming readout before year-end will clarify target patient profiles and dosing strategies for Phase 3 planning.

• Clinical hold was resolved quickly after addressing FDA concerns about transient liver enzyme elevations, with 200 of 216 patients completing dosing.

• Dosing at 200 mg is considered optimal, with no significant benefit observed at 400 mg.

Patient selection and subgroup analysis

• Patient pool is heterogeneous, with 75% in the expansion phase being earlier-stage (metformin or diet/exercise, within seven years of diagnosis).

• Subgroup analysis uses accepted academic criteria: age at diagnosis, BMI, HbA1c, HOMA-IR, and HOMA-beta.

• About half of the population is insulin-deficient, the other half insulin-resistant; BMI is a key factor for future precision medicine approaches.

• Future therapies may use BMI as a practical decision-making tool for treatment selection.

Durability, dosing, and non-response

• Durability data show some patients respond after only four weeks of dosing, but others may need longer or higher doses.

• Non-responders often had insufficient drug exposure or more insulin resistance; GLP-1 failures may still benefit.

• Drug absorption is optimized by dosing two hours after a meal, with protocols now standardized for all patients.