Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BMF-219 · 2 trials · 2 indications
Mean change from baseline in stimulated C-peptide AUC.
Assessed by treatment emergent adverse events. (TEAEs), drug discontinuation due to TEAEs, serious adverse events, clinically significant laboratory, vital, and ECG evaluations.
Assessed by effect of fed conditions on serial and sparse pharmacokinetic data.
Assess the change in HbA1c from baseline to week 26.
| Arm | Type | Description |
|---|---|---|
| Part 1 | EXPERIMENTAL | Part 1 uses a randomized, open-label design with parallel assignment between 2 treatment arms in each cohort. The Part 1 Eligible participants will be randomly assigned by cohort to 1 of 2 treatment arms: * Cohort 1: Participants with T1D diagnosed within 3 years with C-peptide concentration ≥0.2 nmol/L * Arm A: BMF-219 100 mg QD for 12 weeks * Arm B: BMF-219 200 mg QD for 12 weeks * Cohort 2: Participants with T1D diagnosed between 3 to 15 years with C-peptide concentration ≥0.08 nmol/L. * Arm A: BMF-219 100 mg QD for 12 weeks * Arm B: BMF-219 200 mg QD for 12 weeks |
| Part 2 | EXPERIMENTAL | Part 2 Part 2 uses a randomized, double-blind, placebo-controlled design with parallel assignment among 3 treatment arms. Eligible participants will be randomly assigned to 1 of 3 arms using a 1:1:1 ratio: * Arm A: BMF-219 100 mg QD for 12 weeks * Arm B: BMF-219 200 mg QD for 12 weeks |
| Placebo Comparator | PLACEBO_COMPARATOR | Part 2 Study Double Blind Arm C matching placebo for 12 weeks. |
| Phase 1 SAD Cohorts | EXPERIMENTAL | Phase 1 SAD Cohorts with healthy adults randomized 3:1 receiving BMF-219 or placebo. A pair of sentinel subjects (randomly assigned 1 active drug and 1 placebo) will be dosed 48 hours prior to dosing of the remainder of subjects in each cohort. |
| Phase 1 single dose food effect sub-study | EXPERIMENTAL | Phase 1 single dose food effect sub-study with healthy adults randomized 1:1:1:1:1:1 receiving BMF-219 or placebo fasted, with a low-fat meal, and with a high fat meal. |
| Phase 1 single dose tablet PK sub-study | EXPERIMENTAL | Phase 1 single dose x3 PK tablet open-label sub-study with healthy adults randomized 1:1 receiving BMF-219 or placebo fasted, with a low-fat meal, and with a high-fat meal). |
| Phase 2 MAD Cohorts | EXPERIMENTAL | Phase 2 MAD Cohorts with healthy adults (MAD 1, randomized 3:1) or adults with T2D (MAD 2-4 \& 6-8, randomized 5:1) receiving BMF-219 or placebo. MAD 5 is BMF-219 only. |
| Phase 2 Expansion Cohort | EXPERIMENTAL | Phase 2 Expansion Cohort adults with T2D randomized 3:1 ratio receiving BMF-219 or placebo. |
| Name | Type | Description |
|---|---|---|
| BMF-219 | DRUG | BMF-219 is an orally bioavailable, covalent small-molecule menin inhibitor. |
Inclusion Criteria: 1. Males or females, age ≥18 and ≤70 years. 2. Diagnosed with stage 3 T1D within the following timeframes: * Part 1 Cohort 1: Participants diagnosed within 3 years prior to screening. * Part 1 Cohort 2: Participants diagnosed between 3 to 15 years prior to screening * ...
BMF-219 is an investigational small molecule being studied for the treatment of Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus. It is being developed by Biomea Fusion, Inc. (BMEA) and is currently in Phase 2 clinical development for these metabolic indications.
BMF-219 is a small molecule therapeutic being developed for diabetes. Its specific molecular target has not been disclosed in available information, so its exact mechanism of action is not detailed here.
BMF-219 is being developed by Biomea Fusion, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol BMEA. The company is conducting clinical trials of BMF-219 in both Type 1 and Type 2 diabetes mellitus.
BMF-219 is in Phase 2 clinical development. It has completed a Phase 1 trial in healthy subjects and adults with Type 2 diabetes, and a Phase 2 trial in participants with Type 1 diabetes has also been completed. BMF-219 is not yet approved and remains investigational.
BMF-219 has been studied in two completed clinical trials. NCT05731544 was a Phase 1 study in healthy adults and adults with Type 2 diabetes, enrolling 443 participants in the United States and Canada. NCT06152042 was a Phase 2 trial in 37 participants with Type 1 diabetes, also conducted in the United States and Canada.
No alternative names for BMF-219 have been reported. It is identified solely by its code name BMF-219 in clinical trial registries and by its developer, Biomea Fusion, Inc.