U.K. MHRA Grants Meeting to CytoDyn to Discuss Fast Track Approval of Leronlimab for COVID-19 Patients

U.S. FDA schedules Type A meeting with CytoDyn to discuss BLA filing for HIV   

VANCOUVER, Washington, Sept. 02, 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 the Medicines & Healthcare product Regulatory Agency (MHRA) of the U.K. government requested a meeting with CytoDyn on September 9, 2020 to discuss the Company’s request for Fast Track approval of leronlimab to treat COVID-19 patients with mild-to-moderate symptoms based upon the trial’s Top-line Report and additional eIND data. On the suggestion of the MHRA, CytoDyn will submit its current Phase 3 CD12 study for severe-to-critical COVID-19 patients in the UK to the Urgent Public Health (UPH) Research scheme to receive possible financial support from the trial sites and the government, if the UPH deems the Company’s CD12 trial an urgent health issue.

In addition, the U.S. Food and Drug Administration (FDA) advised the Company the agency has scheduled a Type A meeting on September 8, 2020, following the Company’s receipt of the agency’s written responses on September 1 concerning it Biologic License Application (BLA) for leronlimab as a combination therapy for highly treatment-experienced HIV patients. The FDA clarified the items it needed primarily related to dosage levels.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, “We are very encouraged by the MHRA’s considering fast track approval of leronlimab and granting us a meeting. In this meeting, CytoDyn will present a summary of its BLA for HIV in conjunction with our request for fast track approval for COVID-19 indication. We are also grateful to the MHRA for advising us about potential financial support from the sites and UK government for our CD12 study currently in process. We also look forward to meeting with the FDA to help expedite the resubmission of our BLA, as well as learning whether we receive Emergency Use Approval for leronlimab for COVID-19 or, alternatively, are required to proceed with a Phase 3 trial. Regardless, we are working diligently to ensure the availability of leronlimab worldwide to provide a potential benefit for patients infected with this terrible disease.”