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Capricor Therapeutics Announces FDA Acceptance Of Its IND Application For A Phase 2 Clinical Trial Of CAP-1002 In Patients With COVID-19

– The INSPIRE Trial is a Randomized, Placebo-Controlled, Multi-Center Study Evaluating the Safety and Efficacy of Intravenous Infusion of CAP-1002 – –The Study Leverages Capricor's Lead Asset,

Benzinga · 08/25/2020 13:17

– The INSPIRE Trial is a Randomized, Placebo-Controlled, Multi-Center Study Evaluating the Safety and Efficacy of Intravenous Infusion of CAP-1002 –

–The Study Leverages Capricor's Lead Asset, CAP-1002 Technology–

LOS ANGELES, Aug. 25, 2020 (GLOBE NEWSWIRE) -- Capricor Therapeutics ("Capricor") (NASDAQ:CAPR), a clinical-stage biotechnology company focused on the development of first-in-class cell and exosome-based therapeutics for the treatment and prevention of diseases, announced today that the U.S. Food and Drug Administration (FDA) has accepted its investigational new drug (IND) application for a Phase 2 clinical trial of CAP-1002 in patients with COVID-19. The study will enroll patients who have a confirmed diagnosis of SARS-CoV-2 and require supplemental oxygen. Enrollment is expected to commence shortly.

The INSPIRE trial is a randomized, double-blind, placebo-controlled study that will enroll up to 60 patients from multiple, geographically diverse trial sites across the United States. Patient participation will be a maximum of 13 weeks from screening.

"We greatly appreciate the continued support and encouragement by the FDA as we advance our CAP-1002 program for treatment of COVID-19," said Linda Marbán, Ph.D., Capricor's president and chief executive officer. "Based on the data from the initial emergency use individual patient compassionate care cases, we see continued momentum and support for CAP-1002 for the treatment of COVID-19. It is important to remember that many patients are suffering from long term cardiac consequences from COVID-19. As CAP-1002 directly targets cardiac dysfunction, CAP-1002 potentially may also be an important tool in the treatment of the cardiac complications of COVID-19, which represents a patient population with an unmet medical need."

The promise of CAP-1002 in COVID-19 is its immunomodulatory properties, which have been demonstrated in multiple clinical trials as well as in critically ill COVID-19 patients. Multiple published peer-reviewed studies of CDCs have demonstrated favorable modulation of various inflammatory cytokines and regulation of the immune response. The current understanding of COVID-19's later stages are thought to be due to overstimulation of the immune system, which triggers a cytokine storm in which the body is overwhelmed with pro-inflammatory molecules. This immune response may become excessive and pathologic, inducing ARDS, multi-system organ failure and death.

"Our ability to leverage the CAP-1002 program to treat the early to mid-stages of the cytokine storm in COVID-19 patients may reduce the need for ventilatory support and may potentially not only save lives but also reduce long-term morbidity that can occur after severe respiratory compromise. We look forward to sharing further updates on this program as they become available," added Dr. Marbán.

For further information regarding the CAP-1002 INSPIRE safety & efficacy trial, seewww.clinicaltrials.gov.

About 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 COVID-19. Capricor is also investigating the field of extracellular vesicles and exploring the potential of exosome-based candidates to treat or prevent a variety of disorders. We are now developing two potential vaccines for COVID-19 as part of our exosome platform. For more information,visitwww.capricor.comand follow the Company onFacebook,InstagramandTwitter.