UPDATE - Impressive Results From CytoDyn’s Phase 2 COVID-19 Trial - Seite 2

Jacob Lalezari, M.D., Senior Science Advisor to CytoDyn, added, “We are delighted to see a clinically meaningful reduction in SAEs in the mild-moderate COVID-19 population. Leronlimab has been extremely well tolerated in prior clinical trials in over 750 HIV+ patients. These new safety data are therefore consistent with our prior experience and very encouraging in the COVID-19 population. The once-a-week subcutaneous administration of leronlimab is also convenient for patients and caregivers alike. We eagerly anticipate the results of the full efficacy analysis and hope to soon provide the world a broadly effective therapeutic option for this devastating pandemic.”

Nader Pourhassan, Ph.D. President and Chief Executive Officer of CytoDyn, concluded, “We are very pleased to see clear advantages for the patients in this population in leronlimab versus placebo in regards to SAEs and look forward to announcing all of the efficacy endpoints very soon. We are equally optimistic and look forward to the Data Safety Monitoring Committee’s upcoming review of the progress of our Phase 3 trial for COVID-19 patients with severe and critical indications and remain hopeful the therapeutic benefits for this patient cohort will be consistent with the results we saw from the administration of leronlimab to over 60 patients under eIND authorizations previously granted by the U.S. Food and Drug Administration.” 

About Coronavirus Disease 2019
CytoDyn has met its 75-patient enrollment target in its Phase 2 clinical trial for COVID-19, a randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. and enrollment continues in its Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals throughout the country.

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.