Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BMF-219 · 1 trial · 1 indication
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 |
|---|---|---|
| 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 | Investigational Product |
Inclusion Criteria: Healthy Subject Inclusion Criteria: 1. Males or females, age ≥18 and ≤65 years. 2. BMI ≥18 and ≤35 kg/m2. 3. Subjects are healthy on the basis of their medical history, physical examination, ECG, and routine laboratory data. 4. All subjects must be willing and able to provide w...
BMF-219 is an investigational small molecule being developed for the treatment of Type 2 Diabetes Mellitus. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
BMF-219 is being developed by Biomea Fusion, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol BMEA.
BMF-219 is in Phase 1 clinical development. A Phase 1 study has been completed, and the drug remains investigational, meaning it has not been approved for commercial use.
BMF-219 has been studied in a Phase 1 clinical trial with the identifier NCT05731544, titled 'Study of BMF-219 in Healthy Adult Subjects and in Adult Subjects With Type 2 Diabetes Mellitus (T2D).' This trial was completed and enrolled 443 participants in the United States and Canada.
No, BMF-219 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial, but it has not received marketing approval from the U.S. Food and Drug Administration or any other regulatory agency.