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Capricor Therapeutics Announces Positive Final Data From its Phase 2 HOPE-2 Trial in Patients with Duchenne Muscular Dystrophy Treated with CAP-1002
–Trial Met its Primary Efficacy Endpoint of Mid-level Performance of Upper Limb (PUL) v1.2 (p=0.01)– –Additional Positive Endpoints of Full PUL v2.0 (p=0.04)
About this update from Capricor Therapeutics, Inc.
[{"type":"text","content":"–Trial Met its Primary Efficacy Endpoint of Mid-level Performance of Upper Limb (PUL) v1.2 (p=0.01)– –Additional Positive Endpoints of Full PUL v2.0 (p=0.04) and Cardiac Endpoint of Ejection Fraction (p=0.002)– –One-Year Results Demonstrated CAP-1002 Slowed Decline by 71% (Mid-level PUL v1.2)– –CAP-1002 Significantly Improved Cardiac Function in Patients– –Results Presented Today at World Muscle Society Annual Meeting in Late Breaking Oral Presentation– –Principal Investigator Dr. Craig McDonald and Capricor Management Team will Host a Conference Call and Webcast Today at 8:30 a.m. ET– LOS ANGELES, Sept. 24, 2021 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR) (“Capricor” or “the Company”), a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of a broad spectrum of diseases, announced today positive final data from the HOPE-2 clinical trial using CAP-1002 to treat patients in advanced stages of Duchenne muscular dystrophy (DMD). The HOPE-2 clinical trial met its primary efficacy endpoint of mid-PUL v1.2 as well as various skeletal and cardiac endpoints suggesting clinically relevant slowing of disease progression. CAP-1002 is Capricor’s cell-based therapeutic candidate whose mechanism of action is immunomodulatory, anti-fibrotic and has been shown to regenerate skeletal and cardiac muscle cells. This final data will be presented today at this year’s World Muscle Society Virtual Congress (WMS). Dr. Craig McDonald, the national principal investigator for the HOPE-2 clinical trial and UC Davis professor and chair of the Department of Physical Medicine and Rehabilitation commented, “This groundbreaking study is extremely exciting as we saw statistically significant changes of CAP-1002 in both skeletal and cardiac function. For these older boys who have limited therapeutic options, these data support the belief that CAP-1002 may become an important therapeutic option and possibly slow the progression of DMD.” HOPE-2 was a randomized, double-blind, placebo-controlled, Phase 2 clinical trial of the Company’s lead investigational therapy, CAP-1002, in boys and young men who have DMD and are non-ambulant, the later stage of the disease process. The trial was conducted at nine sites across the United States. Study patients were treated via intrav...