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CytoDyn to meet with FDA to finalize protocol for pivotal trial of flagship drug leronlimab

Published: 12:36 07 Jun 2019 BST

Tiles spell out Aids and HIV
CytoDyn CEO Nader Pourhassan says a monotherapy with leronlimab, if approved, may allow patients with 'pill fatigue to maintain a disciplined compliance regimen'

CytoDyn Inc (OTCMKTS:CYDY) said Friday that the US Food and Drug Administration has requested an in-person meeting to discuss and potentially finalize the biotechnology company’s protocol for a trial of flagship drug leronlimab as a single treatment for HIV patients.

The Vancouver-based biotech said the latest investigative monotherapy trial for HIV has now produced “sufficient data” for the company to design a pivotal monotherapy Phase 3 trial.

The company’s main product candidate leronlimab is an injectable antibody that shows promise as an antiviral agent with fewer side effects, lower toxicity and less frequent doses than daily therapies now in use for the treatment of HIV.

READ: CytoDyn files pivotal trial protocol with FDA for flagship drug leronlimab as monotherapy for HIV

On a separate note, the company said Friday that it is developing a collaborative clinical trial agreement to initiate a HIV prevention study with leronlimab to be conducted and fully funded by a public health agency in Southeast Asia.

“There are over 130,000 individuals using a currently approved drug for the prevention of HIV. The side effects and long-term morbidities are well known, which include kidney and liver complications, bone density issues, headaches, abdominal pain and weight loss,” said CytoDyn CEO Nader Pourhassan in a statement. “Based on leronlimab’s mechanism of action, our collaborating partners are very excited to initiate a prevention study, and we share their enthusiasm about the possibilities.”

Leronlimab acts as a viral-entry inhibitor

Dr Pourhassan said the potential role of the CCR5 co-receptor in the prevention of and cure for HIV is well documented and has been the subject of intense media attention.

In the HIV and AIDS setting, leronlimab acts as a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells.

“There is only one self-injectable humanized monoclonal antibody, leronlimab, which is near approval that targets CCR5. Leronlimab is one dose-a-week, sub-cutaneous injection that has all the characteristics of potentially becoming a major therapeutic contributor to the field of HIV and perhaps in cancer and auto-immune diseases,” said Dr Pourhassan.

The CEO acknowledged that backing from the company’s shareholders had enabled CytoDyn to advance leronlimab towards an anticipated FDA approval, in addition to exploring “many opportunities in various cancer indications, any of which could offer significant benefits and rewards for patients throughout the world.”

The FDA earlier granted fast track designation — which bring drugs that fill an unmet need to market faster — to leronlimab in combination with HAART, or highly active antiretroviral therapy, for HIV treatment. Leronlimab has successfully completed nine Phase 1/2/3 clinical trials in more than 700 people, the company said.

Contact Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter@UttaraProactive 

 

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