CytoDyn says the Philippines FDA approves the use of leronlimab to treat a COVID-19 patient

CytoDyn Inc (OTCQB:CYDY) revealed Monday that the Department of Health, Food and Drug Administration in the Philippines has approved the use of its flagship drug candidate leronlimab to treat a COVID-19 patient under compassionate special permit (CSP). As a follow-up to the Philippines FDA order number 2016-005, CytoDyn said it is shipping leronlimab to its partner Chiral Pharma Corporation, who is its importer in the Philippines. In a statement, Chiral Pharma President Francis Gomez said: “On behalf of all COVID-19 patients in the Philippines, we are pleased with this progress and we are in ongoing discussions with the Philippines FDA to obtain emergency use authorization (EUA) approval for leronlimab as a treatment in an effort to reduce COVID-19 mortality.” READ: CytoDyn says 20 patients enrolled and dosed so far in Vyrologix trial in coronavirus long-haulers “We will also seek CSP approval for leronlimab for COVID-19 long-hauler patients in the Philippines,” he added. Meanwhile, CytoDyn CEO Nader Pourhassan thanked the team for working "relentlessly to advance" the firm's drug to CSP approval in the Philippines. “Our expanded CytoDyn team is also working with several other countries to provide COVID-19 patients access to leronlimab,” added Pourhassan. Separately, CytoDyn announced on Monday that the Journal of Translational Autoimmunity had published an article titled “Case study of a critically ill person with COVID-19 on ECMO (extracorporeal membrane oxygenation) successfully treated with leronlimab.” Pourhassan singled out Sohier Elneil from the University College London for her “strong contributions” to the positive study. He also thanked Jacob Lalezari from Quest Clinical Research, for his role based on his “deep knowledge” of leronlimab. “The discharge of this patient from intensive care after prolonged ECMO support following administration of our drug is consistent with data from our recently completed Phase 3 trial where five out of six patients on ECMO recovered and eINDs for critically ill COVID-19 patients,” said the company. CytoDyn said it hoped the study would advance “awareness of the benefits of leronlimab in the broader medical community.” The Vancouver, Washington-based biotechnology company's leronlimab works by mitigating what is known as the cytokine storm, a hyperactive immune response that can cause inflammation, fatigue and, in severe cases, organ failure. Aside from COVID-19, the FDA has granted Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first is a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Contact the author Uttara Choudhury at uttara@proactiveinvestors.com Follow her on Twitter: @UttaraProactive