Biomea Fusion (BMEA) Piper Sandler 36th Annual Healthcare Conference summary

Company evolution and research focus

• Transitioned from oncology to diabetes by targeting Menin, a scaffold protein, with a covalent inhibitor.

• Demonstrated Menin inhibition can stimulate beta cell production and insulin secretion, controlling diabetes in animal and human cell models.

• Advanced to human trials, completing single and multiple ascending dose studies, with ongoing efforts to optimize dosing.

• Identified diabetes as a heterogeneous disease, requiring precision medicine approaches for different patient phenotypes.

• Subgroup analysis shows greater efficacy in insulin-deficient (slender) patients compared to insulin-resistant (overweight) ones.

Clinical trial progress and data insights

• Completed phase 2 study (COVALENT-111) with over 200 patients, categorizing them by phenotype for targeted analysis.

• Safety profile established across 400 patients in oncology, diabetes, and healthy volunteers; transient liver enzyme elevations noted at higher doses.

• FDA review led to protocol adjustments: start dosing at 100mg before escalating to 200mg to mitigate liver enzyme concerns.

• Dose response observed from 100mg to 400mg, with Menin gene downregulated by about two-thirds, not to zero.

• Upcoming readout will clarify optimal patient profile, dosing, and duration (8 vs. 12 weeks, 100 vs. 200mg).

Patient stratification and data presentation

• Patient subgroups defined using academic criteria: age at onset, BMI, HbA1c, HOMA-IR, and HOMA-Beta.

• Both academic and BMI-based stratification will be used for clarity and regulatory alignment.

• Three dosing cohorts (8 and 12 weeks at 100 and 200mg) will be analyzed, with top-line efficacy and safety data expected soon.

• Efficacy measured by HbA1c reduction, aiming to surpass 0.5% placebo-adjusted drop for clinical relevance.

• Longer dosing may yield greater beta cell mass and improved outcomes.