The FDA Accepts Investigational New Drug (IND) Application for a Phase 2 Clinical Trial of CAP-1002 from Capricor Therapeutics Inc. (NASDAQ:CAPR)

Capricor Therapeutics Inc. (NASDAQ:CAPR) is one of the companies fully involved in investigating exosome science. The company’s exosome technology is reportedly active in several disease models. The innovative technology has built a large body of scientific research and has continued to facilitate new approaches to treating Duchenne muscular dystrophy (DMD) and COVID-19.

There seems to be a new observation of the current global menace by the COVID-19 pandemic, the immune system’s overstimulation. This results in a cytokine storm causing an overwhelmed body from pro-inflammatory molecules. Excessive and pathologic immune response may bring forth multi-system organ failure and, eventually, death.

Acceptance of Capricor Therapeutics’ Investigational New Drug (IND) Application

The company has been getting a lot of support from the FDA in the trials of its lead candidate, CAP-1002, a treatment supposedly for COVID-19. The FDA has accepted its investigational new drug (IND) application for a Phase 2 clinical trial of the drug candidate. The double-blind and placebo-controlled study; the INSPIRE will enroll up to 60 patients from different trial sites across the United States. The participants must have a confirmed diagnosis of SARS-CoV-2 and a confirmation that they require supplemental oxygen.

According to Capricor’s CEO Linda Marbán, CAP-1002 has demonstrated a strong potential to treat COVID-19. Its immunomodulatory properties are promising, as well as data from the initial emergency use. The fact that it targets cardiac dysfunction makes it even a more important tool of Treatment of the cardiac dysfunction occasioned by COVID-19.

CAP-1002 consists of Allogeneic Cardiosphere-Derived Cells

“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…” Dr. Marbán explained, adding that this would save not only lives but also reduce long-term illnesses.

Meanwhile, it is worth mentioning that CAP-1002 consists of a type of cardiac cell therapy, which has been present in the pre-clinical and clinical studies. Allogeneic cardiosphere-derived cells or CDCs employ potent immunomodulatory activity. Investigations are underway to establish whether or not it can adjust the immune system’s activity.