Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Icovamenib
BMF-219 · 4 trials · 3 indications
Mean change in HbA1c from baseline
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 |
|---|---|---|
| Arm A: icovamenib 100 mg | EXPERIMENTAL | Starting on Day 1, participants will receive icovamenib or placebo 100 mg QD in addition to their currently prescribed GLP-1or GIP/GLP-1 RA based regimen. Treatment will last for 12 weeks. At Week 12, participants will continue on a stable dose of their baseline Ozempic-based regimen. The total duration of the trial is approximately 57 weeks (including screening and follow-up) |
| Arm B: matching placebo 100 mg | PLACEBO_COMPARATOR | Starting on Day 1, participants will receive matching placebo QD in addition to their currently prescribed GLP-1-based regimen. Treatment will last for 12 weeks. At Week 12, participants will continue on a stable dose of allowable GLP-1-based regimen. The total duration of the trial is approximately 57 weeks (including screening and follow-up). |
| Arm B: placebo matching 100 mg | PLACEBO_COMPARATOR | placebo matching 100mg QD in addition to their currently prescribed antihyperglycemic medication(s) for 12 weeks. At Week 12, participants will continue on their currently prescribed antihyperglycemic medication(s). The total duration of the trial is approximately 56 weeks |
| 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 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 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 |
|---|---|---|
| icovamenib 100 mg | DRUG | icovamenib 100 mg |
| Placebo | DRUG | Matching placebo |
| icovamenib 100mg | DRUG | icovamenib 100mg |
| BMF-219 | DRUG | BMF-219 is an orally bioavailable, covalent small-molecule menin inhibitor. |
Key Inclusion Criteria: 1. Males or females, age ≥18 years and ≤75 years 2. Have been diagnosed with T2D 3. Taking FDA-approved GLP-1 based therapy (administered as subcutaneous injection) and have been treated with lifestyle management and 0 to 2 additional antihyperglycemic medications (metformin...
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.