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CytoDyn says Novant Health initiates Phase 2b/3 trial with leronlimab for critically ill coronavirus patients

Published: 07:55 08 May 2020 EDT

CytoDyn says Novant Health initiates Phase 2b/3 trial with leronlimab for critically ill coronavirus patients
CytoDyn said patients enrolled in the trial are expected to be given leronlimab for two weeks with the primary endpoint being the mortality rate at 28 days, and a secondary endpoint mapping the mortality rate at 14 days.

CytoDyn Inc (OTCQB:CYDY), a late-stage biotechnology company, announced Friday that Novant Health is initiating patient enrollment in a Phase 2b/3 trial for CytoDyn’s flagship drug candidate leronlimab in treating severely and critically ill coronavirus (COVID-19) patients.

At least 54 patients have been treated with leronlimab so far under the US Food and Drug Administration’s emergency Investigational New Drug (IND) program, said the company in a statement. 

Preliminary results from this patient population led to the FDA’s nod for CytoDyn’s Phase 2b/3 clinical trial for 390 patients, which is randomized and placebo-controlled with a 2:1 active drug to placebo ratio.

READ: CytoDyn posts manuscript on how its drug leronlimab restores immune balance in critical coronavirus patients

The Vancouver, Washington-based company said patients enrolled in the trial are expected to be given leronlimab for two weeks with the primary endpoint being the mortality rate at 28 days, and a secondary endpoint mapping the mortality rate at 14 days. The company will perform an interim analysis on the data from 50 patients.

“We’re grateful for our partnership with CytoDyn and the opportunity to bring cutting edge, innovative and investigative treatments to our community,” said Eric Eskioglu, who is the chief Medical Officer for Novant Health.

“Since initiating the leronlimab mild/moderate last month, Novant Health has screened nearly 400 patients for eligibility. A number of these patients have been enrolled and treated on the mild/moderate clinical trial. Expanding treatment options for our more critically ill patients is a vital step in our fight against COVID-19,” he added.

Eskioglu said the company was “encouraged” by positive early reports of leronlimab working for critically ill patients treated under the FDA’s emergency Investigational New Drug program. He added that they are “eagerly awaiting the full results” of blinded studies for leronlimab in the near future from CytoDyn.

“We are once again very pleased Novant Health is seeking to partner with our health care professionals to help provide a potential therapeutic benefit to these COVID-19 patients,” said CytoDyn CEO Nader Pourhassan in a statement.

“Thus far, we are grateful for the benefits leronlimab has provided to so many patients, as expressed to us by their families,” he added.

CytoDyn is developing leronlimab to battle multiple diseases ranging from coronavirus, HIV, certain breast cancers and NASH, or nonalcoholic fatty liver disease.

Contact the author Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive

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