Los Angeles-based biopharmaceutical company Capricor Therapeutics (NASDAQ: CAPR) announced some very encouraging results regarding the success of its flagship product in treating the COVID-19 disease. It reported a 100% survival rate in six critical condition COVID-19 patients who were given its off-the-shelf cardiac cell therapy CAP-1002 as part of a study located at Cedars-Sinai Medical Center. Capricor Therapeutics SEC Filings
Most patients removed from ventilator support
The one-month study involved six patients that all suffered from acute respiratory distress syndrome (ARDS) and all but one were on mechanical ventilatory support. Four out of the five ventilator-supported patients no longer needed ventilator support within four days of the treatment.
The patients, five male and one female, varied widely in age from 19 to 75 and all received IV infusions of 150 million allogeneic cardiosphere-derived cells, also known as CAP-1002. After the infusion, several patients showed improvements in biomarkers such as ferritin, absolute lymphocyte counts and C-reactive protein (CRP). No adverse effects of the treatment were observed and four of the patients have been discharged from the hospital.
FDA approves study expansion
The data led the U.S. Food and Drug Administration (FDA) to approve Capricor’s expanded access protocol involving the treatment of up to 20 more COVID-19 patients.
Capricor CEO Dr. Linda Marban commented, “As the global medical community continues to come together in its battle against COVID-19, the results of our initial compassionate care cases are extremely promising and what we had anticipated. We look forward to continuing to treat additional patients under our recently approved expanded access program Investigational New Drug application.”
The success of the CAP-1002 is believed to be due to the therapy’s ability to modulate the human body’s immune system. The later stages of COVID-19 are thought to be caused by an overstimulation of the immune system which results in the body being overwhelmed with pro-inflammatory molecules which can lead to pneumonia, organ failure, and death.
In addition to the COVID-19 study, Capricor is also in the late stages of developing CAP-1002 for the treatment of the fatal genetic disease Duchenne muscular dystrophy (DMD). There are presently only two approved drugs in the U.S. for the treatment of DMD and only 21% of DMD patients are being treated. The top-line results of this study named HOPE-2 are expected to be release by mid-May 2020.
Another promising area for Capricor is its extracellular vesicle, or exosome platform technology. The field of exosomes represents an increasing market opportunity for the company. The global exosome diagnostic and therapeutic market is forecast to grow at an annual rate of 27.7% through 2027 and reach $580 million in revenue.
Capricor Therapeautics stock is covered by two analysts both of which have buy ratings. In response to the company’s positive COVID-19 data Capricor shares skyrocketed more than 250% in heavy volume as of late-day trading on April 29th. The company is scheduled to report quarterly results on May 11th. Capricor Therapeutics SEC Filings