The withdrawal is related to the quality of the data collection and monitoring of the pivotal clinical trials by the clinical research organization.
CytoDyn has voluntarily withdrawn its pending biologics license application (BLA) for leronlimab, a humanized monoclonal that targets the CCR5 receptor, to treat people with HIV who are multi-drug resistant (MDR).
The withdrawal is related to the quality of the data collection and monitoring of the pivotal clinical trials by the clinical research organization (CRO) contracted to manage the trials, the company said in a press release.
“We have decided to voluntarily withdraw our BLA for the HIV-MDR population at this time only after extensive review and deliberation, including audits from three external independent regulatory quality firms,” Cyrus Arman, Ph.D., president of CytoDyn, said in the press release. “While the company met its primary endpoints in these pivotal trials, which we think is a clear indication that leronlimab performs well in the clinic, we believe the issues identified in each of the three independent audits related to the quality of the data collection and oversight by the CRO make it difficult to support a successful BLA regulatory submission.”
The BLA was based on data from phase 2b/3 placebo-controlled assessing leronlimab, in combination with a highly active antiretroviral therapy (HAART), to treat highly treatment-experienced HIV patients. In July 2020, the company received a refusal to file letter from the FDA regarding its BLA submission for leronlimab. The FDA cited deficiencies related to data presentation and related analyses, and also requested clarifications regarding the manufacturing processes.
In November 2021, CytoDyn resubmitted the non-clinical and chemistry, manufacturing, and controls sections of the BLA. The contract manufacturing company, however, at that time refused to release the clinical data, and in March 2022, the FDA had placed a partial clinical hold on CytoDyn’s HIV program.
Company officials believe the data it currently possesses is sufficient to complete and submit its responses to the FDA to seek the removal of the clinical hold placed on the company's HIV program. CytoDyn plans to publish the safety and efficacy data in which it met its primary endpoint, in its phase 2b/3 placebo-controlled trial for the HIV-MDR population
The company is also studying leronlimab to treat other HIV-related diseases, non-alcoholic steatohepatitis (NASH), and oncology indications.