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CytoDyn is set to collaborate with the National Institutes of Health (NIH) of Mexico to conduct a clinical trial of its CCR5 antagonist, leronlimab, to treat patients with severe/critical Covid-19.
Patient enrolment is currently ongoing for a Phase IIb/III clinical trial for 390 patients, along with a Phase II study for 75 patients with mild-to-moderate Covid-19 infection.
CytoDyn received more than sixty emergency investigational new drug (eIND) authorisations from the US Food and Drug Administration (FDA). Data for this patient population is expected to be available later this week.
CytoDyn president and CEO Nader Pourhassan said: “We look forward to working with the NIH of Mexico to rapidly commence with the proposed study.
“We also believe that this study results, along with the ongoing Phase II study, could establish a path for quick approval in Mexico for use of leronlimab in Covid-19 patients.”
The company is preparing to file a protocol with the FDA for a factorial design trial, which will compare the effectiveness of leronlimab to remdesivir, as well as evaluate a combination with remdesivir to treat Covid-19.
CytoDyn chief science officer Jacob Lalezari said: “We believe the randomised head-to-head comparison of leronlimab to remdesivir and in combination will provide answers to the lingering question regarding effective treatment options for patients suffering from Covid-19.
“We look forward to working both in the US and with potential international sites to help provide effective treatment options for Covid-19.”
Last month, the company reported positive data from a small observational Covid-19 study, which involved ten patients under emergency new drug authorisations at Montefiore Medical Center at the Albert Einstein College of Medicine, New York City, US.
Initial data showed that the drug reduced the plasma viral load and restored the immune system of Covid-19 patients.