Business
Capricor Therapeutics Reports First Quarter 2023 Financial Results and Provides Corporate Update
-Enrollment Continues to Progress in HOPE-3, the Phase 3 Clinical Trial of CAP-1002 in Duchenne Muscular Dystrophy (DMD); On Track to Report Interim Analysis
About this update from Capricor Therapeutics, Inc.
[{"type":"text","content":"-Enrollment Continues to Progress in HOPE-3, the Phase 3 Clinical Trial of CAP-1002 in Duchenne Muscular Dystrophy (DMD); On Track to Report Interim Analysis in Fourth Quarter of 2023- -Plan to Present 24-Month HOPE-2 Open Label Extension Data in Second Quarter of 2023- -To Host Conference Call and Webcast Today at 4:30 p.m. ET- SAN DIEGO, May 11, 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, announced today its financial results for the first quarter ended March 31, 2023 and provided a corporate update. “We are pleased with the progress of our late-stage clinical development program for CAP-1002 in patients with DMD and are well positioned to deliver on important clinical and regulatory milestones throughout 2023,” said Linda Marbán, Ph.D., Capricor’s chief executive officer. “We plan to present 24-month follow-up data from our ongoing HOPE-2 open label extension study (OLE) in the second quarter of 2023, and with enrollment for our Phase 3 HOPE-3 trial progressing, we remain on track to report the interim analysis in the fourth quarter of 2023. Furthermore, based on the positive data from our previous clinical trials, we are currently working with the FDA to determine the most expeditious path to registration for CAP-1002 in DMD. In parallel, we are exploring opportunities for additional partnerships outside of the United States and Japan to maximize the value of this asset.” First Quarter 2023 and Recent Operational Developments CAP-1002 Duchenne Muscular Dystrophy Program HOPE-3, our Phase 3 clinical trial of CAP-1002 in DMD continues to progress well. The multi-center, randomized, double-blind, placebo-controlled study (NCT05126758) is designed to treat up to 68 subjects in the United States. At this time, we have 13 active sites and we expect to fully enroll the currently designed study by the second half of 2023.Continued discussions with FDA following our Type-B CMC meeting regarding commercial plans in anticipation of a potential BLA submission and we have now submitted a request for a Type-B clinical meeting.Completed construction of new San Diego GMP manufacturing facility and plan to have commercial-scale GMP CAP-1002 product ...