CytoDyn Inc (OTCQB:CYDY), which is developing Vyrologix (leronlimab-PRO 140) for multiple indications, revealed that Chiral Pharma Corporation placed its first purchase order for leronlimab under a compassionate special permit (CSP), to treat critically ill coronavirus (COVID-19) patients in the Philippines.
The Vancouver, Washington-based late-stage biotech will earn revenue after order fulfillment and the terms of the agreement are ironed out.
In a statement, CytoDyn Chief Operating Officer Dr Chris Recknor said: "One of the patient successes was recently reported last week on One News Philippines TV station. This patient had severe COVID-19 with deteriorating lung function despite treatment with antivirals and steroids.”
READ: CytoDyn to send topline results from severe coronavirus trial of leronlimab to regulators in India and the Philippines
“Testing was significant for high inflammation in the blood with Ferritin 17x elevated. Oxygen saturation on maximum oxygen flow was only 82% (normal >95%). Twenty hours after receiving 700 mg of leronlimab subcutaneously at the patient's home, the patient's heart rate decreased from 120s to low 90s.”
Shortly thereafter, the company said the patient “regained appetite, improved lung function, and had reduced inflammation with Ferritin down to 4x elevated.” At week two, the patient went off oxygen support after the second dose was also given at home.
“At week three, the patient continued to improve in stamina and returned to routine physical activities,” added Dr Recknor. “Inflammation markers were still elevated with Ferritin still two times elevated, so a third dose was given. At week four, the patient is currently back to normal life activities."
Dr Recknor noted that although the CSP data is not randomized double-blinded control, the case reports from the Philippine CSP are “consistent with CD12 prespecified major endpoint metrics.”
“Leronlimab when combined with standard of care is better than standard of care alone like antivirals or dexamethasone and may improve clinical outcome status four times better than standard of care at day 14 (p< 0.021) and reduce hospital stays by as much as 6 days (p<0.005) with a higher likelihood of returning to activities of daily living without limitations versus placebo control in critical COVID patients," said Dr Recknor.
In COVID-19 patients, 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.
“After we provided leronlimab, free of charge, for the first 100 patients in the Philippines for critically ill COVID-19 patients, we are now on a clear path to achieving revenue with our first purchase order,” said CytoDyn CEO Nader Pourhassan.
Meanwhile, CytoDyn is working with Philippine Airlines as its “preferred partner” in transporting leronlimab quickly to the Philippines. The carrier will help transport leronlimab vials from Los Angeles to Manila on nonstop flights.
"We believe that through the collaborative efforts of both companies, many Filipino lives can be saved,” said Chiral Pharma COO Oscar Z Siangco Jr.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
Follow her on Twitter: @UttaraProactive