logo-loader
viewCytoDyn Inc.

CytoDyn files IND and Phase 2 protocol with FDA for use of leronlimab in treating NASH

The 60-patient, multi-center, randomized, placebo-controlled Phase 2 study is designed to test the safety and potential in adult patients

CytoDyn - CytoDyn files IND and Phase 2 protocol with the FDA for the use of leronlimab in treating NASH
Leronlimab blocks CCR5, a cellular receptor, which has found to be important in non-alcoholic fatty liver disease

CytoDyn Inc (OTCMKTS:CYDY) revealed Wednesday that it has filed an Investigational New Drug (IND) application and a Phase 2 clinical trial protocol with the US Food and Drug Administration for its flagship drug leronlimab to treat patients with non-alcoholic steatohepatitis (NASH).

NASH is a chronic liver disease characterized by liver inflammation and damage caused by a buildup of fat in the liver. Patients with this disease are often told they have a "fatty liver."

In a statement, the Vancouver, Washington-based late-stage biotechnology company said leronlimab blocks CCR5, a cellular receptor, which has found to be important in HIV infection, tumor metastases, and NASH.

READ: CytoDyn files Phase 2 protocol with FDA for use of leronlimab and regorafenib as combo therapy for metastatic colorectal cancer

The company said that based on published reports of the involvement of CCR5 in the pathogenesis of nonalcoholic fatty liver disease, and following the company’s positive preclinical data, the Phase 2 trial is designed to test whether leronlimab can control "the devastating liver fibrosis" associated with NASH.

“We are cautiously optimistic about the potential of leronlimab to provide a new therapeutic option for individuals diagnosed with NASH. We again thank the men and women who have agreed to participate in our trials,” said CytoDyn CEO Nader Pourhassan in a statement.

The 60-patient, multi-center, randomized, double blind, placebo-controlled Phase 2 study is designed to test the safety and efficacy of leronlimab (PRO 140) in adult patients with NASH. 

NASH develops in the absence of excessive alcohol consumption but is linked to unhealthy eating habits and lack of physical activity.

The IND program is the means by which a pharma company obtains permission to start human clinical trials and to ship an experimental drug across state lines usually to clinical investigators before a marketing application for the drug has been approved.

Contact Uttara Choudhury at [email protected]

Follow her on Twitter: @UttaraProactive 

Quick facts: CytoDyn Inc.

Price: 3.07 USD

OTCMKTS:CYDY
Market: OTCQB
Market Cap: $1.32 billion
Follow

Add related topics to MyProactive

Create your account: sign up and get ahead on news and events

NO INVESTMENT ADVICE

The Company is a publisher. You understand and agree that no content published on the Site constitutes a recommendation that any particular security, portfolio of securities, transaction, or investment strategy is...

In exchange for publishing services rendered by the Company on behalf of CytoDyn Inc. named herein, including the promotion by the Company of CytoDyn Inc. in any Content on the Site, the Company receives from said...

FOR OUR FULL DISCLAIMER CLICK HERE

Watch

Full interview: CytoDyn Get US FDA approval to move to FastTrack to Phase 2...

CytoDyn (OTCQB: CYDY) CEO Nader Pourhassan joined Steve Darling from Proactive to discuss the company getting U.S. FDA  clearance to start a Phase 2 trial with leronlimab to treat COVID-19 patients with mild to moderate indications.  Pourhassan telling Proactive why they have been...

1 day, 4 hours ago

2 min read