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Also known as BHV-2000, BMS-986089
Taldefgrobep Alfa · 2 trials · 5 indications
Change in MFM-32 total score from baseline to Week 48. Scores range from 0-3 on each item. The scores from the 32 items are summed and transformed to a 0-100 scale, with higher scores reflecting higher levels of functional abilities.
| Arm | Type | Description |
|---|---|---|
| taldefgrobep alfa | EXPERIMENTAL | taldefgrobep alfa - Double-blind (DB) Phase: Participants receive weight based 35 mg/50 mg weekly subcutaneous injection for 48-week DB phase. taldefgrobep alfa/taldefgrobep alfa - Extension Phase: Participants receive weight based 35 mg/50 mg weekly subcutaneous injection for Open label Extension (OLE) phase. |
| Placebo | PLACEBO_COMPARATOR | Placebo - Double-blind (DB) Phase: Participants receive weight based 35 mg/50 mg weekly subcutaneous injection for 48-week DB phase. Placebo/taldefgrobep alfa - Extension Phase: Participants who receive placebo during DB phase, receive weight based 35 mg/50 mg weekly subcutaneous taldefgrobep alfa injection for OLE phase. |
| Taldefgrobep Alpha once weekly | EXPERIMENTAL | - |
| Placebo once weekly | PLACEBO_COMPARATOR | - |
| Taldefgrobep Alpha once every 4 weeks | EXPERIMENTAL | - |
| Placebo once every 4 weeks | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| taldefgrobep alfa | DRUG | DB Phase: 35 mg/50 mg weekly subcutaneous injection |
| Placebo | DRUG | DB Phase: matching placebo 35 mg/50 mg weekly subcutaneous injection |
Key Inclusion Criteria: * Spinal Muscular Atrophy confirmed by genetic diagnosis of 5q-autosomal recessive SMA as well as SMN2 copy number * Ambulant or Non-Ambulant * Treated with an SMA disease-modifying therapy and anticipated to remain on that same treatment regimen and dose throughout the tria...
Top 6 of 7 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Biogen Inc. | BIIB | 13 | PHASE3 | Nusinersen, Salanersen |
| Novartis AG Sponsored ADR | NVS | 7 | PHASE3 | Onasemnogene abeparvovec |
| Biohaven Ltd. | BHVN | 1 | PHASE3 | Taldefgrobep Alfa |
| Scholar Rock Holding Corp. | SRRK | 2 | PHASE3 | Apitegromab |
| argenx SE Sponsored ADR | ARGX | 1 | PHASE2 | ARGX-119 |
| Hoffmann-La Roche | RHHBY | 2 | PHASE2 | Risdiplam, RO7204239 |
Taldefgrobep Alfa is an investigational small molecule developed by Biohaven Ltd. (ticker BHVN) that is being studied for obesity and overweight and for spinal muscular atrophy. It is in clinical development and has not been approved by the FDA. It is being tested in a Phase 2 obesity trial and a Phase 3 spinal muscular atrophy trial.
Taldefgrobep Alfa targets myostatin. By binding myostatin, the drug is designed to modulate this signaling pathway, which is relevant to muscle mass regulation in both metabolic and neuromuscular conditions. Biohaven Ltd. is developing the small molecule across obesity and spinal muscular atrophy indications.
Taldefgrobep Alfa is developed by Biohaven Ltd., which trades under the ticker BHVN. Biohaven is running the clinical program for the drug in obesity and overweight and in spinal muscular atrophy, including a Phase 2 obesity study and a Phase 3 spinal muscular atrophy study.
Taldefgrobep Alfa is in Phase 2 development for obesity and overweight and in Phase 3 development for spinal muscular atrophy. It is investigational and has not been approved by the FDA. The Phase 2 obesity trial is active but not recruiting, and the Phase 3 spinal muscular atrophy trial is also active but not recruiting.
Taldefgrobep Alfa is being studied in NCT07281495, a Phase 2 trial in adults with overweight and obesity enrolling 150 participants in the United States, and NCT05337553, a Phase 3 trial in participants with spinal muscular atrophy enrolling 269 participants across the United States, Belgium, Czechia, Germany, Italy, Netherlands, Poland, Spain, and the United Kingdom. Both are active but not recruiting.
Taldefgrobep Alfa is a small molecule that targets myostatin, placing it in the myostatin-targeting class of investigational therapies. It is being developed by Biohaven Ltd. (BHVN) for obesity and overweight and for spinal muscular atrophy, with one Phase 2 trial and one Phase 3 trial currently active but not recruiting.