CytoDyn Inc (OTCQB:CYDY) said Tuesday that the US Food and Drug Administration (FDA) has given the nod for the start of a Phase 2 trial with its lead drug leronlimab to treat coronavirus (COVID-19) in patients with mild to moderate indications.
Patients enrolled in the trial are expected to have a treatment window of approximately 6 weeks. Leronlimab is intended to serve as a therapy for patients experiencing respiratory complications as a result of the virus.
The company’s investigational new drug, leronlimab, has already been given to 10 severely ill coronavirus patients at a medical center in New York City under an emergency Investigational New Drug Application (IND) recently granted by the FDA.
The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled study to evaluate the potential and safety of leronlimab in mild to moderately ill coronavirus patients and calls for 75 patients to enroll in up to 10 centers in the US.
Bruce Patterson, an advisor to CytoDyn and CEO of IncellDx, said the company was “very pleased” with the FDA’s responsiveness to facilitate the important Phase 2 trial.
“In light of the test results of the various immunologic markers from the critically ill patients treated under the emergency IND, we remain hopeful that leronlimab may be therapeutically beneficial to those COVID-19 patients with mild to moderate indications," he added.
Meanwhile, CytoDyn CEO Nader Pourhassan acknowledged that the FDA has been “very collaborative” with its team to “accelerate the opportunity to introduce a potentially beneficial treatment” to so many patients affected by the pandemic.
“We hope to complete enrollment of this trial very quickly,” he added.
Adequate funds to bring drug to market
Separately, CytoDyn also completed a new non-dilutive convertible debt offering with an institutional investor, which provides $15 million of immediately available capital.
The note has a two-year maturity, bears interest at the rate of 10% per annum and is secured by all assets of the company, excluding its intellectual property. During the first six months following the issue date, the investor may convert principal into common stock up to one million shares per month after which all or any part of the outstanding balance of the note is convertible into common stock.
“We are pleased to close on this round of funding as we begin our journey towards commercialization,” said CytoDyn CFO Craig S Eastwood.
“Non-dilutive capital of this nature gives us the momentum we need to forge ahead with our therapeutic indications and provides a foundation to bring leronlimab to market, which is targeted for the fourth quarter of 2020,” he added.
Contact the author Uttara Choudhury at [email protected]
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