On a recent conference call with the FDA, US regulators recognized that the higher dosage of 700mg in a monotherapy trial for leronlimab, an injectable antibody which takes aim at HIV, had a much higher response rate than the 350mg dose used in a combination therapy trial.
To avoid a delay in the filing of the drug’s Biologics License Application (BLA) submission, the FDA has agreed to accept safety data from 100 patients in the monotherapy trial with the 700mg dose of leronlimab. This concession allows for the drug’s BLA submission for the combination therapy to use 700 mg of the drug instead of the original 350 mg dose.
“The successful interim results in the 700 mg monotherapy arm prompted the FDA to allow CytoDyn to switch all remaining combination therapy patients from its CD02-Extension study from a 350 mg to a 700 mg dose,” a company statement explained.
In a statement, CytoDyn CEO Nader Pourhassan said the company is already arranging meetings with potential commercial partners to assess distribution and prepare for the drug’s anticipated approval.
“We are extremely appreciative of the agency’s guidance for the approval process for the world’s first self-injectable antibody for HIV,” said Dr Pourhassan.
“We believe we can realize significant revenue opportunities by 2020 assuming the first approval of leronlimab,” he added.
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 the human immunodeficiency virus (HIV), which causes acquired immune deficiency syndrome (AIDS).
CytoDyn shares slipped 1% to finish at $0.48 on Thursday.
Contact Ellen Kelleher at [email protected]