Edgewise Therapeutics Submits EDG-7500 Phase 3 Protocol After Favorable FDA Feedback
Edgewise Therapeutics received favorable FDA feedback regarding EDG-7500 for symptomatic hypertrophic cardiomyopathy. Following the End-of-Phase 2 meeting, the company submitted the protocol for STRATUS-HCM, incorporating a tolerability-based dose-escalation plan without safety echo monitoring. STRATUS-HCM is a global, randomized, double-blind, placebo-controlled Phase 3 trial projected to enroll approximately 600 adult patients, including about 200 with obstructive HCM and 400 with nonobstructive HCM.
Edgewise Therapeutics, Inc. (EWTX) announced favorable feedback from its End-of-Phase 2 meeting with the U.S. Food and Drug Administration regarding EDG-7500 for symptomatic obstructive and nonobstructive hypertrophic cardiomyopathy (HCM).
After the meeting and subsequent receipt of the minutes, Edgewise submitted the protocol for STRATUS-HCM. The protocol incorporates the trial’s overall design and assessments, including a proposed tolerability-based dose-escalation plan without safety echo monitoring.
STRATUS-HCM is designed as a global, randomized, double-blind, placebo-controlled Phase 3 trial. It is expected to enroll approximately 600 adults with symptomatic HCM, comprising about 200 adults with obstructive HCM and 400 with nonobstructive HCM.
This article may include AI-generated content that is human-reviewed, which is for reference and general information purposes only and does not constitute investment advice.
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