Capricor Therapeutics, Inc. (NASDAQ: CAPR) has reported encouraging additional safety data from its ongoing clinical trial, resulting in an upward trajectory for its shares. At the latest market check, CAPR stock increased to $4.80 rising 3.54% on the stock charts.
Promising HOPE-2 Study Results
Capricor (CAPR), concentrating on its flagship product, deramiocel, intended to treat Duchenne muscular dystrophy (DMD), reported encouraging three-year safety and effectiveness data from its HOPE-2 open-label extension (OLE) research.
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A number of cardiac metrics, such as left ventricular ejection percent and indexed volumes including left ventricular end-systolic volume and left ventricular end-diastolic volume, showed improvements, according to results from the HOPE-2 OLE research.
These measures are essential for evaluating heart health and forecasting long-term results. Furthermore, patients with higher initial ejection fractions in the HOPE-2 randomized trial showed greater improvements in cardiac function.
Implications For DMD Treatment
The published data emphasize the importance of early intervention to maintain function and potentially decelerate the progression of cardiomyopathy, a leading cause of mortality in DMD patients. Currently, no approved treatment exists specifically for DMD cardiomyopathy, highlighting the necessity for new therapies.
Additionally, patients in the HOPE-2 OLE study exhibited a statistically significant improvement in the PUL v2.0 total score compared to an external comparator dataset of similar DMD patients.
The study also continues to demonstrate a favorable safety profile for long-term treatment with deramiocel. These findings will be presented at the Parent Project Muscular Dystrophy (PPMD) 30th Annual Conference in Orlando, Florida, on June 29, 2024.
Future Prospects And Regulatory Plans
The results of the open-label study are crucial for DMD patients, showing sustained skeletal and cardiac benefits after three years of continuous treatment with deramiocel. This underscores the potential long-term benefits of this therapy for DMD patients.
Building on the HOPE-2 OLE data and prior clinical results, Capricor plans to discuss with the U.S. Food and Drug Administration (FDA) options to expedite their Biologics License Application (BLA) filing. The company remains committed to working closely with the FDA to bring deramiocel to patients promptly and anticipates sharing further updates as they become available.
