CytoDyn Files for Expanded Access Use of Leronlimab for Multi-Drug Resistance HIV Patients
CytoDyn will request FDA permission to charge HIV MDR patients under expanded access
VANCOUVER, Wash.--(BUSINESS WIRE)-- CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today filed a request with the U.S. Food and Drug Administration (“FDA”) for approval of expanded access use of leronlimab for multi-drug resistance (MDR) HIV patients. The Company has also previously sought FDA approval for CytoDyn to charge for leronlimab used in this patient population and is preparing to file the last portion of this request.
Recent data reported in “NIH-Funded Study Estimates Global Progress Toward UNAIDS Goal” indicates there are still far too many HIV patients who experience difficulty in achieving suppressed viral load. A viral load of about 1000 cp/mL or less is needed to ensure patients cannot transmit HIV to others. The MDR HIV patients are at the risk of contracting AIDS when their condition progresses such that their CD4 count drops below 200 cp/mL.
Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer, commented, “ Our Phase 3 pivotal trial, which yielded a statistically significant primary endpoint for efficacy (p=0.0032), had an 81% success rate in suppressing viral load (VL<50 cp/mL) in the MDR population after 24 weeks of leronlimab treatment. This compares to other recent antibody products approved for this population with around 45% suppressed viral load .
This population of HIV patients has limited treatment options, and almost all those who completed our pivotal Phase 3 trial, CD02, requested to continue with leronlimab treatment in an extension arm of our CD02 trial. Currently we have 24 patients (almost half of the patients in CD02), on leronlimab treatment, some for as many as four years. Expanded access approval from the FDA will allow us to provide leronlimab to MDR HIV patients who are in great need of a new regimen to add to their current ones. Additionally, CytoDyn will be filing final documentation with the FDA soon in connection with its request to charge for the use of leronlimab under expanded access.”