CytoDyn Inc (OTCQB:CYDY), the late stage biotech, said partner Novant Health has started enrolling patients in the company's Phase 2 randomized clinical trial using leronlimab for coronavirus (COVID-19) patients with mild-to-moderate symptoms.
Novant Health is the second trial site in the USA and the first site in the southeastern US to initiate this Phase 2 trial.
READ: CytoDyn collaborating with UK’s Department of Health to provide emergency access to leronlimab for critically ill coronavirus patients
Earlier on Wednesday, it was reported that the death toll from the virus in the US now stands at nearly 13,000 and there were nearly 2,000 deaths between Tuesday and Wednesday. New York state alone recorded 731 deaths on Tuesday.
"COVID-19 is the most significant health threat of our generation,” said Dr. Eric Eskioglu, executive vice president and chief medical officer at Novant Health in a statement.
"We want to thank CytoDyn for partnering with us in this very important leronlimab clinical drug trial. With lives at risk, we are working together towards an effective treatment solution."
"Based upon the results we have seen with several New York patients, we are hopeful that leronlimab can provide a benefit to patients throughout the country," added Nader Pourhassan, the president and CEO at CytoDyn
The Novant Health network cares for around 5 million patients a year at nearly 700 locations, including 15 hospitals and hundreds of outpatient facilities and physician clinics.
A second trial this week
CytoDyn is also initiating a second COVID-19 trial this week.
This study is a Phase 2b/3 for severely ill COVID-19 patients and is for 342 patients, double-blinded with a 2:1 ratio (drug to placebo ratio).
Patients enrolled in this trial are expected to be administered leronlimab for two weeks, with the primary endpoint being the mortality rate at 28 days and a secondary endpoint of mortality rate at 14 days.
The company said it will perform an interim analysis on the data from 50 patients.
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