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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=...). 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.”

The INSPIRE trial (NCT04623671) is a Phase 2, randomized, double-blind, placebo-controlled study that will enroll up to 60 patients with a COVID-19 clinical diagnosis confirmed by laboratory testing who are in severe or critical condition as indicated by life-support measures. The study’s primary objectives are to determine the safety and effectiveness of the intravenously infused CAP-1002 for improving clinical outcomes. Patients will be randomized to either the CAP-1002 or placebo group (1:1 ratio) and undergo baseline safety and efficacy assessments approximately one to three days prior to administering the investigational product.

Dr. Marbán continued, “Based on data from the initial emergency use cases, we are encouraged by the potential of our cell-based therapy, CAP-1002, for treating COVID-19. Many patients are now suffering from COVID-19’s long-term cardiac consequences. As CAP-1002 directly targets cardiac dysfunction, it has the potential to serve as an important tool in treating the virus’s cardiac complications--an unmet medical need in today’s patient population. We are now actively enrolling subjects in Texas and California where case levels continue to rise. We expect to have data available in the first half of 2021 and will continue to evaluate potential partnering opportunities for this program.”

CAPRICOR THERAPEUTICS

Capricor Therapeutics, Inc. (NASDAQ: CAPR) is 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 diseases. Capricor's lead candidate, CAP-1002, is an allogeneic cell therapy that is currently in clinical development for the treatment of Duchenne muscular dystrophy and the cytokine storm associated with COVID-19. Capricor is also investigating the field of extracellular vesicles (EVs) and exploring the potential of exosome-based candidates to treat or prevent a variety of disorders. The company is now developing two potential vaccines for COVID-19 as part of its exosome platform. For more information, visit www.capricor.com.

[Capricor press release] [Capricor Therapeutics]