Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
forazapadin · 1 trial · 1 indication
Incidence, temporal profile, and severity of treatment emergent adverse events (TEAEs)
Change in muscle force measurements as determined by dynamometry
| Arm | Type | Description |
|---|---|---|
| forazapadin (SAT-3247) 60 mg | ACTIVE_COMPARATOR | - |
| forazapadin (SAT-3247) 120 mg | ACTIVE_COMPARATOR | - |
| placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| forazapadin | DRUG | Forazapadin (SAT 3247) is a potent, orally available, muscle penetrant, small molecule inhibitor of AAK1 |
| Placebo Comparator | DRUG | Matching placebo oral tablets |
Inclusion Criteria: * definitive diagnosis of FSHD1 or FSHD2, confirmed by clinical findings and prior genetic testing results * presence of weakness in upper limbs at Screening, defined as a Brooke score ≥ 2 * presence of weakness in a lower limb at Screening, defined as a MRC score of ≤4 on ankle...