CytoDyn Inc (OTCQB:CYDY) announced Monday it is partnering with Mexican health authorities to conduct a clinical trial of leronlimab for severe and critically ill coronavirus (COVID-19) patients, with the potential to collaborate on additional coronavirus trials.
In a statement, the company said it has entered into a Memorandum of Understanding (MOU) with the National Institutes of Health and High Specialty Hospitals of Mexico (NIH), which coordinates the main medical care and public research institutions.
Under the MOU, CytoDyn said it will supply leronlimab at its own expense to the NIH and that both parties are proceeding expeditiously to complete the mutually-agreed protocol for the clinical trial.
READ: CytoDyn meets 75 patient enrollment for Phase 2 trial of leronlimab for patients with mild-to-moderate symptoms of COVID-19
“We are very pleased with the confidence demonstrated by the NIH of Mexico in our drug, leronlimab, and we are both very motivated to initiate this trial quickly to help mitigate the devastation of the COVID-19 pandemic on the citizens of Mexico,” CytoDyn CEO Nader Pourhassan said.
He added the trial will test only 25 patients, a small sample size the company believes could prompt a quick approval of the drug in Mexico.
CytoDyn said it has met its 75-patient enrollment target in its Phase 2 clinical trial for COVID-19, a randomized clinical study for mild-to-moderate COVID-19 patients in the US. Also, enrollment continues in its Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 patients in several hospitals throughout the US.
Leronlimab was previously granted Fast Track designation by the US Food and Drug Administration for its indications as a treatment for metastatic triple-negative breast cancer and as part a combination therapy for HIV-infected patients.
For COVID-19, the FDA has granted a so-called rolling review for the drug as part of its biologics license application submission.
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