CytoDyn finalizes key test which will guide discussions with FDA on lead drug leronlimab as a monotherapy

CytoDyn Inc (OTCMKTS:CYDY), a late-stage biotechnology company developing leronlimab (PRO 140) as a monotherapy for HIV patients, said Thursday that it had completed a key test which would “guide” discussions with the US Food and Drug Administration on leronlimab as a single treatment for HIV. 

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.

The Vancouver, Washington-based biotech announced the development of a receptor occupancy test to measure the expression of CCR5 in HIV and tumor cells that are occupied by leronlimab.

READ: Breakthrough test predicts which HIV patients will respond to CytoDyn’s leronlimab as a monotherapy

In layman’s terms, a receptor occupancy assay measures the degree to which the test drug occupies its target receptor in tissues.

Development of this test could more precisely guide CytoDyn in identification of patients at screening for monotherapy, said the company in a statement.

Stellar results

To date, over 830 HIV patients have participated in clinical trials with leronlimab (PRO140), including over 600 patients in ongoing and previous monotherapy trials. There have been no drug related serious adverse events reported in any of the HIV patients treated with leronlimab, said the company.

In addition, the response rate has been as high as 95% for the first 10 weeks of leronlimab monotherapy in HIV patients taking a 525-milligram dosage, said the company.  

Identifying patients who can respond to leronlimab monotherapy at the screening is critical for therapeutic success, said the company, while emphasizing that the development of the Receptor Occupancy Test is a “significant milestone” that may further increase the monotherapy response rate.

“The development of the receptor occupancy test is an important milestone for CytoDyn because it may allow more precise screening for leronlimab monotherapy,” said CytoDyn CEO Nader Pourhassan. “Over 600 HIV patients that have taken leronlimab as a single agent over the years have had no drug related serious adverse events.

In-person meeting with the FDA

It’s been a busy spell for the company as CytoDyn has been granted an in-person meeting with the FDA to discuss its pivotal monotherapy protocol that could lead to label expansion approval should leronlimab have its first approval as a combination therapy.

Dr Pourhassan says a monotherapy with leronlimab, if approved, may allow patients with ‘pill fatigue to maintain a disciplined compliance regimen.’

“The potential for leronlimab to be a safe and effective treatment for HIV with highly accurate dosing is an important driver of continued excitement and support from key opinion leaders within the medical community,” said Dr Pourhassan.

The company said over 110 HIV active patients on leronlimab monotherapy for almost one year and five patients from the company’s original Phase 2 monotherapy extension have now reached almost five years on monotherapy without viral breakthroughs. 

Furthermore, the company is evaluating the safety and potency of flagship drug leronlimab in multiple indications including cancer, GvHD and fatty liver disease, or NASH.

Contact Uttara Choudhury at [email protected]

Follow her on Twitter: @UttaraProactive 

Story by ProactiveInvestors