CytoDyn Announces Voluntary Withdrawal of its application for leronlimab in HIV-MDR due to CRO Data Management Issues

CytoDyn announced that it has voluntarily withdrawn its pending BLA for leronlimab (humanized mAb to CCR5), as a combination therapy with current SoC ART for highly treatment-experienced patients with HIV with resistance to highly active antiretroviral therapy (HAART), in the HIV multi-drug resistant population (HIV-MDR).

The decision to voluntarily withdraw was based on various factors, including systemic issues 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, resulting in significant concerns with achieving a successful FDA BLA approval.

The Company is of the opinion that FDA approval for the HIV-MDR indication is not feasible without significant additional investment to remedy the issues.

CytoDyn plans to publish soon the safety and efficacy data in which it met its primary endpoint, in its Phase 2b/3 randomized, double-blinded, placebo-controlled trial for the HIV-MDR population, in a peer-reviewed journal.

The company believes 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.

The Company will continue to leverage the performance of leronlimab in these and other studies to advance leronlimab in other HIV-related, non-alcoholic steatohepatitis (NASH), and oncology indications – where compelling data has been generated – that may benefit a greater number of patients. For example, the Company plans to continue to pursue other underserved HIV-related indications, where it can potentially be first to market. Leronlimab Fast Track designation for metastatic triple-negative breast cancer.

Source: press release