Safety Concerns Cloud Promising Phase 2 Results of Edgewise Therapeutics’ HCM Drug Candidate” ###
Study Overview:
Edgewise Therapeutics' cardiac drug EDG-7500, a selective cardiac sarcomere modulator, demonstrated substantial efficacy in Phase 2 clinical trials for treating hypertrophic cardiomyopathy (HCM). Key benefits included reductions in left ventricular outflow tract gradients (up to 71%) and clinically meaningful decreases in NT-proBNP, a biomarker of heart failure125.
Efficacy Highlights:
For obstructive HCM, a 100 mg dose reduced resting LVOT-G by 71% and increased patient symptom improvement, with 78% improving by one or more NYHA classes.
For nonobstructive HCM, a 42% reduction in NT-proBNP was observed, with positive trends in diastolic function metrics125.
Safety Concerns:
While most adverse events were mild to moderate, two serious cases of atrial fibrillation (AF) requiring cardioversion were reported.
Dizziness and upper respiratory tract infections were the most frequent side effects1.
The reported AF rates were comparable to other cardiac myosin inhibitors in trials, but they overshadowed the promising efficacy data in the market perception of the drug1.
Market and Competitive Landscape:
EDG-7500 aims to rival established HCM treatments like Bristol Myers Squibb’s Camzyos and Cytokinetics' pending drug, aficamten. Unlike Camzyos, EDG-7500 achieved results without worsening left ventricular ejection fraction (LVEF), a critical safety advantage135.
Future Plans:
Edgewise plans to optimize dosing strategies in upcoming trial phases, with Phase 3 initiation scheduled for the first half of 202615.
Financial Impact:
Despite safety concerns, Edgewise announced a $200M stock offering, intended to fund future clinical trials. However, shares dropped by over 30% following the safety data release1.
Clinical Implications:
The drug’s potential remains significant due to its ability to treat both obstructive and nonobstructive HCM without compromising systolic function, addressing a large unmet need in HCM treatment25.
Sources:
1. https://www.fiercebiotech.com/biotech/edgewise-sees-heart-pressure-reductions-potential-camzyos-rival
2. https://www.stocktitan.net/news/EWTX/edgewise-therapeutics-announces-positive-top-line-results-from-phase-1b086ns9xnsz.html
3. https://www.prnewswire.com/news-releases/edgewise-therapeutics-announces-positive-top-line-results-from-phase-2-cirrus-hcm-four-week-trial-of-edg-7500-in-hypertrophic-cardiomyopathy-hcm-302417857.html
5. https://www.biospace.com/press-releases/edgewise-therapeutics-announces-positive-top-line-results-from-phase-2-cirrus-hcm-four-week-trial-of-edg-7500-in-hypertrophic-cardiomyopathy-hcm