Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BVS857 · 2 trials · 2 indications
Safety was monitored throughout the study.
Safety was monitored throughout the study.
Thigh muscle volume was assessed by magnetic resonance imaging (MRI). Change from baseline was calculated from the ratio of the post-baseline mean value to the baseline mean value: \[(Day 85/baseline) - 1)\] x 100. A positive change from baseline indicates improvement.
| Arm | Type | Description |
|---|---|---|
| BVS857 Part A Open label (Cohort 1) | EXPERIMENTAL | Participants received single doses of 0.01 mg/kg BVS857 intravenously (i.v.) on day 1, 0.01 mg/kg BVS857 subcutaneously (s.c.) on day 15, 0.03 mg/kg BVS857 s.c. on day 29, 0.06 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. |
| BVS857 Part A double blind (Cohort 2) | EXPERIMENTAL | Participants received single doses of 0.03 mg/kg BVS857 i.v on day 1, 0.03 mg/kg BVS857 s.c. on day 15, 0.06 mg/kg BVS857 s.c. on day 29, 0.10 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. (BVS857 concentrations differed on days 43 and 57.) |
| Placebo Part A double blind (Cohort 2) | PLACEBO_COMPARATOR | Participants received single doses of matching placebo i.v. on day 1 and matching placebo s.c. on days 15, 29, 43 and 57. |
| BVS857 Part B open-label (Cohort 4) | EXPERIMENTAL | Participants received 0.1 mg/kg BVS857 i.v. weekly for 12 weeks. |
| BVS857 Part B double blind (Cohort 5) | EXPERIMENTAL | Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks. |
| Placebo Part B double blind (Cohort 5) | PLACEBO_COMPARATOR | Participants received matching placebo i.v. to BVS857 weekly for 12 weeks. |
| BVS857 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| BVS857 | DRUG | BVS857 lyophilisate in vial; the lyophilisate was reconstituted with sterile water for injection, diluted as appropriate, and administered either i.v. or s.c.. |
| Placebo | DRUG | Placebo lyophilisate in vial; the lyophilisate was reconstituted with sterile water for injection, diluted as appropriate, and administered either i.v. or s.c.. |
Key Inclusion Criteria: * Genetic diagnosis of SBMA with symptomatic muscle weakness * Able to complete 2 minute timed walk * Serum IGF-1 level less than or equal to 170 ng/mL Key Exclusion Criteria: * Medically treated diabetes mellitus or known history of hypoglycemia * History of Bell's palsy ...
BVS857 is an investigational small molecule being studied for insulin resistance and spinal and bulbar muscular atrophy. It has been evaluated in clinical trials for these conditions, though it remains in development and is not approved.
BVS857 is being developed by Novartis AG, a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker symbol NVS.
BVS857 has completed a Phase 1 trial in insulin resistance and a Phase 2 trial in spinal and bulbar muscular atrophy. Both trials are completed, and the drug remains investigational.
BVS857 has been studied in two completed trials: NCT01435330, a Phase 1 safety and tolerability study in subjects with insulin resistance, and NCT02024932, a Phase 2 safety, tolerability, and efficacy study in patients with spinal and bulbar muscular atrophy.
BVS857 is not FDA approved. It is an investigational drug that has completed clinical trials but has not received regulatory approval for any indication.