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Also known as Rinvatercept
KER-065 · 1 trial · 1 indication
To evaluate the safety and tolerability of KER-065 in ambulatory and nonambulatory participants with DMD
| Arm | Type | Description |
|---|---|---|
| Cohort A1 (Late Ambulatory) | EXPERIMENTAL | Participants will receive stable corticosteroid (CS) along with KER-065. |
| Cohort A2 (Late Ambulatory) | EXPERIMENTAL | Participants will receive stable CS, exon skipper along with KER-065. |
| Cohort N1 (Early Nonambulatory) | EXPERIMENTAL | Participants will receive stable CS along with KER-065. |
| Name | Type | Description |
|---|---|---|
| KER-065 | DRUG | KER-065 will be administered subcutaneously (SC) |
Key Inclusion Criteria: * Diagnosis of DMD, defined as the presence of phenotypic features at screening consistent with DMD AND documented mutation in the dystrophin gene consistent with the diagnosis of DMD using a clinically validated genetic test. * Receiving a stable regimen of systemic CS (inc...
KER-065 is an investigational small molecule being developed by Keros Therapeutics, Inc. for the treatment of Duchenne Muscular Dystrophy. It is currently in Phase 2 clinical development and has received Orphan Drug designation from the FDA. It is not yet approved for any indication.
KER-065 is being studied as a potential treatment for Duchenne Muscular Dystrophy, a neuromuscular condition. The Phase 2 trial is evaluating its safety and efficacy in participants with the disease. As an investigational therapy, KER-065 has not been approved for use in Duchenne Muscular Dystrophy or any other indication.
KER-065 targets myostatin and activin A. By acting on this signaling pathway, the small molecule is designed to modulate muscle-related biology in Duchenne Muscular Dystrophy. This mechanism is the basis for its ongoing clinical evaluation in that patient population.
KER-065 is being developed by Keros Therapeutics, Inc., which trades on the Nasdaq under the ticker KROS. The company is the sponsor of the ongoing Phase 2 clinical trial of KER-065 in Duchenne Muscular Dystrophy.
KER-065 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA for any indication. The Phase 2 trial is currently recruiting participants with Duchenne Muscular Dystrophy.
KER-065 is being studied in one clinical trial, NCT07704099, titled Safety and Efficacy of KER-065 in Participants With Duchenne Muscular Dystrophy. The Phase 2 trial is recruiting and plans to enroll 36 male participants aged 9 years and older in New Zealand.