CytoDyn Seeks UK Approval of Leronlimab for HIV and COVID-19
• BLA-type submission planned this month in U.K. for HIV combination therapy with 350 mg weekly dose
• COVID-19 Phase 2 topline report to be submitted for consideration of emergency approval of leronlimab for patients with mild-to-moderate symptoms to U.K. and other countries following submission to the U.S. FDA next week
VANCOUVER, Washington, Aug. 06, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company, announced today it will submit requests for pre-submission meetings (equivalent to pre-BLA meeting in U.S.) in the U.K. for leronlimab as an HIV treatment in combination with HAART for highly treatment experienced HIV patients (350 mg dose, self-injectable, subcutaneous ), as well as for emergency approval of leronlimab for COVID-19 patients with mild-to-moderate symptoms (Phase 2 - CD10). CytoDyn will include its topline report from the Phase 2 trial, along with the Clinical Study Report (CSR). The Company will subsequently prepare requests for pre-submission meetings in European Union member countries.
The Company’s submission to Medicines and Healthcare Products Regulatory Agency (MHRA), an executive agency of the U.K. government sponsored by the Department of Health and Social Care, will initiate the process to seek approval for leronlimab as a combination therapy for highly treatment experienced HIV patients using a 350 mg weekly dose. The Company’s previously completed Phase 3 trial for leronlimab as a combination therapy for highly treatment experienced HIV patients met its primary endpoint (p = 0.0032) for the trial based on a 350 mg dosage, self-injectable, once-a-week.
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, “We have been working with MHRA and have provided requested information and we are hopeful that we can quickly and
efficiently move forward with the process of potentially bringing leronlimab to global communities in need. We will also pursue cancer indications in all these countries, as well as other potential
indications for leronlimab.”