Capricor Therapeutics Announces Positive 18-Month Results from Ongoing HOPE-2 Open Label Extension Study of CAP-1002 in Duchenne Muscular Dystrophy Patients

-Statistically Significant Results in Performance of the Upper Limb PUL 2.0 (p=0.02) Extended to 18 Months, Demonstrating Long-Term Benefit in Skeletal Muscle Function-

-Results Continue to Suggest Potential Disease Modification in Duchenne Muscular Dystrophy (DMD)-

-Capricor to Host Webinar in Conjunction with Parent Project Muscular Dystrophy (PPMD) Today at 1:00 p.m. ET-

Excerpt from the Press Release:

SAN DIEGO, Jan. 25, 2023 (GLOBE NEWSWIRE) — Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of muscular and other select diseases, today announced positive 18-month results from its ongoing HOPE-2 open label extension (OLE) study in patients with later-stage Duchenne muscular dystrophy (DMD). Data from the OLE study continues to show evidence for disease modification with statistically significant differences in the Performance of the Upper Limb (PUL version 2.0) scale in the CAP-1002 original treatment group when compared to the original placebo group from HOPE-2 (p=0.02). In addition, disease progression is attenuated equally in both groups once patients begin treatment in the OLE.

“DMD is a progressive disease associated with loss of function over time and there is a critical need for treatment options to slow the rate of decline and preserve upper limb function to enable key everyday activities,” said Dr. Craig McDonald, national Principal Investigator and University of California, Davis, Professor and Department of Physical Medicine and Rehabilitation Chair. “We are encouraged by the improvements in upper limb function in the treatment group at 18-months and will continue to treat and follow these patients to further evaluate the disease modifying potential of CAP-1002. Taken together, these data build on the impressive results from HOPE-2 and suggest that patients accumulate benefit over time with steady preservation of skeletal muscle functions, which underscore the potential long-term benefit of CAP-1002.”

The study met its primary endpoint at the one-year timepoint and continues to show statistically significant improvements (p=0.02) on the Performance of the Upper Limb scale for patients treated with CAP-1002 at 18-months. In the study, CAP-1002 was made available to the original 20 patients enrolled in the HOPE-2 study. Of those, 13 entered and 12 completed 18-months of study follow-up.

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