CytoDyn Seeks UK Approval of Leronlimab for HIV and COVID-19 - Seite 2

The Phase 2 trial to evaluate the efficacy and safety of leronlimab in patients with mild-to-moderate symptoms caused by COVID-19 infection was completed in July 2020. Patients were randomized to receive weekly doses of 700 mg leronlimab, or placebo. Leronlimab and placebo were administered via subcutaneous injection. The Company previously announced patients receiving leronlimab experienced 64% fewer serious adverse events (SAE’s) during the trial than patients receiving placebo.

CytoDyn’s  ongoing Phase 3 (CD12) trial of leronlimab in patients with severe to critical COVID-19 was reviewed by an independent Data Safety Monitoring Committee (“DSMC”), which reported finding no cause to modify the study. The Phase 3 study currently has 173 enrolled patients and the Company will conduct a full interim analysis once 195 patients are enrolled, as provided in the trial’s protocol.

About Coronavirus Disease 2019
CytoDyn completed its Phase 2 clinical trial (CD10) for COVID-19, a randomized clinical trial for mild-to-moderate patients in the U.S. and is currently evaluating the data. Enrollment continues in its Phase 3 randomized clinical trial for the severe to 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 is believed to typically transmit person-to-person through respiratory droplets. 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. 

About Leronlimab (PRO 140)
The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH. Leronlimab has completed nine clinical trials in over 800 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).