CytoDyn Files a Clinical Trial Protocol with the FDA to Treat Severely Ill COVID-19 Patients with Leronlimab where the Primary Endpoint is Mortality Rate at Two Weeks

Recent data from China indicates mortality rate among COVID-19 patients requiring mechanical ventilator is more than 85%

VANCOUVER, Washington, April 01, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that it has filed a second clinical trial protocol with the U.S. Food and Drug Administration (FDA) to treat severely ill COVID-19 patients with leronlimab.  This trial will be conducted under the same FDA-approved IND as the Company’s recently initiated Phase 2 clinical trial to treat COVID-19 patients with mild-to-moderate indications.

The Company’s investigational new drug, leronlimab, has been administered to 10 severely ill patients with COVID-19 at a leading medical center in the New York City area under an emergency IND recently granted by the FDA.

CytoDyn expects to enroll patients in both the Mild-to-Moderately Ill and Severely Ill protocols very quickly under the same IND that was provided with a “safe to proceed” letter from the FDA. The new protocol for Severely Ill COVID-19 patients is for 342 patients, double blinded with 2:1 ratio. Patients enrolled in this trial are expected to be administered leronlimab for two weeks with the primary endpoint being the mortality rate at 14 days.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn said, “Once again, the FDA continues to be very supportive of everyone’s efforts to increase access to leronlimab in order to assess its therapeutic benefits for a broader range of COVID-19 patients. With a study in China indicating the mortality rate among COVID-19 patients requiring mechanical ventilator at more than 85%, the world desperately needs a therapy that can help this patient population.” 

About Coronavirus Disease 2019
SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.