Capricor Announces DSMB Recommendation to Continue Phase 2 INSPIRE Trial for Its CAP-1002 Allogeneic Cell-Based Therapy in Severe COVID-19; CAP-1002 May Attenuate Effects of Cytokine Storm, While Also Acting Against Long-Term Cardiac Complications

On Decembr 29, 2020, Capricor Therapeutics, Inc. (NASDAQ: CAPR), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of first-in-class cell- and exosome-based therapeutics for the treatment and prevention of a variety of diseases and disorders, announced today that the independent Data and Safety Monitoring Board (DSMB) has completed its safety review for Capricor’s Phase II INSPIRE study (https://www.clinicaltrials.gov/ct2/show/NCT04623671?spons=capricor&draw=2&rank=1). The DSMB recommended that the study continue as designed with Capricor’s cardiac cell therapy, CAP-1002, for treating patients with severe COVID-19. In addition, an independent prespecified review of the safety data was conducted on an initial group of INSPIRE patients and the study is continuing according to the study protocol. “As hospitalizations continue to steadily increase heading into the New Year, the DSMB’s recommendation is vital as we continue this study to potentially help patients who are at a high risk for significant morbidity or even death,” said Linda Marbán, PhD, Capricor’s President and CEO. “Given that CAP-1002 polarizes macrophages to an anti-inflammatory, healing immunomodulatory phenotype, it may subsequently attenuate the effects of the cytokine storm associated with severe COVID-19.”