CytoDyn intends to request a Type A meeting with the FDA to discuss its request for additional information. The FDA’s request does not require any additional clinical trials to be conducted, rather the Company will conduct additional analysis of completed trials.
Meanwhile CytoDyn is planning to lock and unblind the Phase 2 *redacted* trial data later this week. Periodic safety review by Data Safety Monitoring Committee (DSMC) for ongoing Phase 3 study (severe/critical population) is planned for next week. Both results are to be announced in July.
In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.