CytoDyn’s monotherapy trial with flagship HIV drug leronlimab exceeds expectations

CytoDyn Inc (OTCMKTS:CYDY), a Vancouver-based biotech announced Tuesday that pivotal human immunodeficiency virus (HIV) monotherapy trial results with flagship drug leronlimab (PRO 140) topped expectations.

New data showed that a weekly dose of 525 mg and 700 mg of leronlimab yielded approximately a 90% response rate for HIV-infected patients who pass the first ten weeks of monotherapy without virologic failure.

Approximately 30% of subjects fail within the first ten weeks of monotherapy on a 525 mg dosage and 17% at a dosage of 700 mg. Patients who pass the first ten weeks of monotherapy on a 525 mg dose have reached an average total of 32 weeks with sustained viral load suppression, said the company.

READ: CytoDyn submits first part of biologics license application to FDA for flagship HIV drug leronlimab

CytoDyn recently filed the non-clinical portion of a Biologics License Application for its flagship leronlimab as a combination therapy for HIV using the US Food and Drug Administration’s rolling review process.

Leronlimab is an injectable antibody that shows promise as an anti-viral agent with fewer side effects, lower toxicity and less frequent doses than daily therapies now in use for the treatment of HIV.

The target of leronlimab is CCR5, a cell receptor that is the entry point for most strains of HIV, which causes acquired immune deficiency syndrome (AIDS).

The CytoDyn team is working to complete the clinical and chemistry, manufacturing, and controls (CMC) information portion of the biologics license application.

The biologics license application is a request for permission to introduce a biologic product for interstate commerce.

Potential label expansion 

The company said that if a 700 mg weekly dose of leronlimab is approved for combination therapy, the approval will serve as a foundation for a potential label expansion for leronlimab as a monotherapy for HIV.

CytoDyn said it is working with IncellDx, a single cell diagnostic company, to perform CCR5 genotyping and quantitative CCR5 expression profiling on cells potentially infectible by HIV to “bring precision medicine” to HIV therapeutics.

“We are excited to help development efforts for the first self-injectable, subcutaneous monotherapy for HIV patients,” IncellDx Inc founder CEO Dr Bruce K Patterson said in a statement.

Dr Patterson’s work has also identified a role of CCR5 in immune cells that regulate the immune response against cancer. The top expert in CCR5, has revealed that through certain lab tests looking at the genetics and expression of CCR5 in individual patients, CytoDyn may more closely match the most effective dose for each HIV monotherapy patient to achieve viral suppression. This dose could be 350 mg, 525 mg or 700 mg, depending on the individual CCR5 receptor density of each patient.

“If leronlimab is proven to be a successful monotherapy and is approved by FDA, it would be a game changer for HIV patients, offering a safe, highly effective, durable, once weekly treatment option,” said CytoDyn CEO Dr Nader Pourhassan. “We are excited that our response rate with the 525 mg and 700 mg dosages is close to 90% for those patients who pass the first ten weeks of monotherapy without virologic failure.”

Contact Uttara Choudhury at [email protected]

Follow her on Twitter: @UttaraProactive 

Story by ProactiveInvestors