CytoDyn Inc (OTCQB:CYDY), a late-stage biotechnology company, revealed Tuesday that it is collaborating with the UK’s Department of Health to provide emergency access to leronlimab (PRO 140), the company’s investigational drug for treating coronavirus (COVID-19) patients.
The submission to the Medicines and Healthcare Products Regulatory Agency (MHRA), an executive agency of the UK government, sponsored by the Department of Health and Social Care, is expected to be made soon to include clinical trial sites in the United Kingdom.
The UK is co-ordinating with Vancouver, Washington-based CytoDyn’s full-service international clinical research organization, Amarex Clinical Research, to complete clinical agreements to prepare for “timely delivery” of leronlimab, the company said in a statement.
READ: CytoDyn enrolls two patients in Phase 2 coronavirus of leronlimab; 15 severely ill patients treated separately so far
The US Food and Drug Administration (FDA) recently gave the nod for CytoDyn to initiate a Phase 2b/3 clinical trial for severe and critically ill coronavirus patients for whom enrollment is now underway. The trial is for 390 patients and will be double-blinded with a 2:1 drug to placebo ratio.
Patients are expected to be given leronlimab for two weeks, and the primary endpoint of the study is the mortality rate after 28 days. There's a secondary endpoint mortality rate at 14 days. An interim analysis of the data will be conducted after the first 50 patients.
Separately, CytoDyn has enrolled and begun treating the first two patients this week in its Phase 2 trial of leronlimab for people with mild-to-moderate coronavirus symptoms. The company expects enrollment to accelerate this week at multiple clinical sites.
Meanwhile, 15 severely ill coronavius patients have been treated with leronlimab so far, primarily in New York, under an emergency investigational new drug designation granted by the FDA for each individual patient.
In a statement, CytoDyn CEO Nader Pourhassan said the company was “humbled by the outpouring of inquiries and requests” for access to leronlimab and is working with its many partners to facilitate access to its drug.:
“We are working with our CRO partner, Amarex Clinical Research, to establish similar expanded access (emergency use) programs for leronlimab for the treatment of COVID-19 with other governmental regulatory authorities,” said Dr Pourhassan added.
“The Amarex team is leading the clinical trial management and conduct of both Phase 2 and Phase 2b/3 projects and has done an exceptional job leading our clinical development initiative for leronlimab for the treatment of COVID-19,” he said.
Separately, Dr Pourhassan will appear on Fox Business Network on April 7 at 11:00 am PT to provide an update on CytoDyn’s two clinical trials for coronavirus which include the Phase 2 trial for patients with mild-to-moderate symptoms, and a Phase 2b/3 trial for severe and critically ill coronavirus patients.
Leronlimab is designed to help by treating the respiratory symptoms caused by coronavirus.
Initial patient test data has shown improvement in cytokines — proteins released by the immune system that can cause inflammation in high quantities — and a more normal ratio of helper T cells to killer T cells in the immune system, known as the CD4/CD8 ratio.
In addition to its use as a potential coronavirus treatment, leronlimab has other therapeutic indications as a treatment for HIV and certain breast cancers. It has already been granted Fast Track status by the FDA for the treatment of HIV in combination with the “cocktail” known as highly active antiretroviral therapy (HAART).
The company has also filed an IND application and a Phase 2 clinical trial protocol with the FDA to treat patients with NASH — damage caused by a build-up of fat in the liver.
Contact the author Uttara Choudhury at [email protected]
Follow her on Twitter: @UttaraProactive