Study of BMF-219 in Healthy Adult Subjects and in Adult Subjects With Type 2 Diabetes Mellitus (T2D)

Summary

A Phase 1/ 2 Randomized, Double-Blind, Placebo-Controlled Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMF-219, an Oral Covalent Menin Inhibitor, in Healthy Adult Subjects and in Adult Subjects with Type 2 Diabetes Mellitus.

Timeline

Start

2022-08-17

Primary completion

2024-11-18

Completion

2025-07-08

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

release “data at ADA 83 rd Scientific Sessions from the first two cohorts of patients with type 2 diabetes from ongoing Phase I/II study (COVALENT-111)” biomeafusion.com ↗

release “For Cohort 3 (100 mg BMF-219 QD without food for 4 weeks): 50% of patients (n=5/10) saw a continued improvement in HbA1c” biomeafusion.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	icovamenib	Small molecule	100 mg	Oral
Subject	icovamenib	Small molecule	200 mg	Oral

Indications