Edgewise presented interim data from its ongoing Phase 2 clinical trial of EDG-7500, an investigational drug targeting hypertrophic cardiomyopathy (HCM). This is a genetic heart condition in which the heart's muscle thickens, affecting its ability to pump blood throughout the body.
Edgewise found that, in the B and C parts of the trial, evidence of clinical activity was detected across significant HCM disease markers. Additionally, the drug maintained a favorable safety profile and was generally well-tolerated.
The current part D of the trial is a 12-week study, and Edgewise said that over 40 participants are enrolled in the trial. As of Dec. 23, the healthcare company wrote, roughly 70% of those individuals had reached a dose of at least 100 milligrams.
In the EDG-7500 update, Edgewise quoted its CEO, Kevin Koch, as saying that "I'm excited about the advances we've made in Part D of the CIRRUS-HCM trial, where we've exceeded our year-end enrollment goal, highlighting continued enthusiasm for the program from patients and physicians."
Judging by the market's reaction to the news, many investors appear to share that enthusiasm. While that's understandable. I'd sound a note of caution here -- no matter how efficacious a drug might appear to be in clinical trials, if it's in Phase 2, it has some distance to go before potentially winning regulatory approval. Still, the latest results from the lab are almost unquestionably encouraging.
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