Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Sevasemten Dose 1
Sevasemten · 4 trials · 2 indications
All participants
All participants
Adult participants
Adult participants
The area under the concentration-time curve, from time 0 to the last observed non-zero concentration (AUC0-t) for sevasemten and metabolites administered with and without verapamil
An AE is any untoward medical occurrence in a patient administered a medicinal product. The AE does not necessarily have to have a causal relationship with the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The numerator of the percentage is the number of participants experiencing at least one AE after first dose of study drug up to 25 months.
An AE is any untoward medical occurrence in a patient administered a medicinal product. The AE does not necessarily have to have a causal relationship with the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The endpoint is the cumulative total number of AEs occurring after first dose of study drug up to 25 months among participants who received at least one dose of study drug.
An AE is any untoward medical occurrence in a patient administered a medicinal product. The AE does not necessarily have to have a causal relationship with the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The severity of an AE is graded, according to the study protocol definitions of AE severity/intensity, as "mild", "moderate" or "severe". Participants who reported multiple AEs are counted only once at the highest severity reported.
| Arm | Type | Description |
|---|---|---|
| Treatment | EXPERIMENTAL | Drug: Sevasemten |
| Adult Cohort 1 | EXPERIMENTAL | Drug: Sevasemten Drug: Placebo |
| Adult Cohort 2 | EXPERIMENTAL | Drug: Sevasemten Drug: Placebo |
| Adult Cohort 6 | EXPERIMENTAL | Drug: Sevasemten Drug: Placebo |
| Adolescent Cohort 4 | EXPERIMENTAL | Drug: Sevasemten Drug: Placebo |
| Adolescent Cohort 5 | EXPERIMENTAL | Drug: Sevasemten Drug: Placebo |
| Treatment A: single dose sevasemten | EXPERIMENTAL | Single dose sevasemten administered on Day 1 under fasting conditions |
| Treatment B: multiple doses of verapamil and single dose of sevasemten | EXPERIMENTAL | Multiple doses of verapamil with a single dose of sevasemten under fasting conditions |
| Treatment C: single dose sevasemten and high-fat meal | EXPERIMENTAL | Single dose sevasemten under high-fat fed conditions |
| Name | Type | Description |
|---|---|---|
| Sevasemten | DRUG | Sevasemten is administered orally once per day |
| Sevasemten 10 mg | DRUG | Sevasemten is administered orally once per day |
| Sevasemten 5 mg | DRUG | Sevasemten is administered orally once per day |
| Sevasemten 12.5 mg | DRUG | Sevasemten is administered orally once per day |
| Placebo | DRUG | Placebo is administered orally once per day |
| Verapamil | DRUG | multiple doses 240mg verapamil |
Key Inclusion Criteria: 1\. Males with a diagnosis of BMD and participation in EDG-5506-002 ARCH, EDG-5506-201 CANYON and GRAND CANYON, or EDG-5506-202 DUNE. Participants are eligible if they complete the respective prior study visits as follows: * EDG-5506-002 ARCH: Complete the final study Visit...
Sevasemten is an investigational small molecule being developed for Duchenne Muscular Dystrophy and Becker Muscular Dystrophy. It is also studied in healthy subjects for drug interaction and food effect evaluations. Sevasemten is in Phase 2 clinical development for these rare neuromuscular diseases.
Sevasemten is a small molecule designed to modulate the fast skeletal muscle troponin complex. By targeting this complex, it aims to stabilize the muscle contractile apparatus and reduce muscle damage associated with muscular dystrophies. This mechanism is being evaluated in Duchenne and Becker Muscular Dystrophy.
Sevasemten is being developed by Edgewise Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker EWTX. The company is conducting Phase 2 clinical trials for Sevasemten in Duchenne and Becker Muscular Dystrophy.
Sevasemten is in Phase 2 clinical development. It is not FDA approved and remains investigational. The drug has received FDA designations including Orphan Drug, Rare Pediatric Disease, and Fast Track for its muscular dystrophy indications.
Sevasemten is being studied in three active Phase 2 trials: NCT05291091 in Becker Muscular Dystrophy, NCT05540860 in children with Duchenne Muscular Dystrophy, and NCT06100887 in children with Duchenne previously treated with gene therapy. A Phase 1 trial in healthy subjects has been completed.
Sevasemten is also known as Sevasemten Dose 1 and Sevasemten 10 mg. The clinical trials listed for Sevasemten reference the compound EDG-5506, indicating these names refer to the same investigational drug being developed by Edgewise Therapeutics.