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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 for the treatment of Duchenne Muscular Dystrophy (DMD). It is currently in Phase 2 clinical development and has not yet been approved by regulatory authorities. The drug is designed to address the underlying muscle degeneration associated with this condition.
KER-065 targets myostatin and activin A, two proteins that regulate muscle growth. By inhibiting these targets, the drug aims to promote muscle mass and strength in patients with Duchenne Muscular Dystrophy. This mechanism is being evaluated in clinical trials to assess its potential therapeutic benefit.
KER-065 is being developed by Keros Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol KROS. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for Duchenne Muscular Dystrophy.
KER-065 is in Phase 2 clinical development. It is an investigational drug, meaning it has not received FDA approval and is still being studied in clinical trials. The drug has been granted Orphan Drug designation by the FDA, which provides incentives to support its development for Duchenne Muscular Dystrophy.
KER-065 is being evaluated in a Phase 2 clinical trial with the identifier NCT07704099, titled 'Safety and Efficacy of KER-065 in Participants With Duchenne Muscular Dystrophy.' This trial is not yet recruiting and plans to enroll 36 male participants aged 9 years and older. The study is controlled but not randomized or double-blinded.