CytoDyn meets 75 patient enrollment for Phase 2 trial of leronlimab for patients with mild-to-moderate symptoms of COVID-19

CytoDyn Inc (OTCQB:CYDY) announced Thursday it has met its 75 patient enrollment for a Phase 2 clinical trial of leronlimab for patients with mild-to-moderate symptoms of COVID-19, the disease caused by the coronavirus.

The randomized trial will evaluate the improvement of several symptoms over a 14-day period, including changes in multiple clinical baseline metrics after days 3, 7 and 14. 

CytoDyn said it expects the evaluation of clinical patient data to be available two weeks after the last patient is enrolled. Because there are more patients who have been screened for enrollment, final enrollment is expected to exceed 75, the company added.

READ: CytoDyn expects to hear a completion date from regulators next month for its leronlimab license application

“Based upon our understanding of clinical outcomes from severe and critically ill COVID-19 patients, we are guardedly optimistic about the potential results from the mild-to-moderate patients,” said CEO Nader Pourhassan in a statement.

“Furthermore, CytoDyn will do an interim analysis of patient data in the Phase 3 trial for severe and critically ill COVID-19 patients and we hope to have these important results in 2 to 3 weeks.”

In the meantime, Vancouver, Washington-based CytoDyn is moving ahead with enrollment for its Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 patients in several hospitals throughout the country.

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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Story by ProactiveInvestors