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Our lead product, Leronlimab (PRO 140), belongs to a new class of HIV/AIDS therapeutics that protects healthy cells from viral infection. HAART, the current standard of care for HIV, waits until the virus enters the cell and begins replicating before it attacks the virus.
Leronlimab is the world’s first self-injectable, subcutaneous injection for HIV. Advantages over the current standard of care, HAART, include no serious side effects and no serious adverse events (SAE’s) related to Leronlimab with exposure to over 800 patients, enhanced compliance, and longer half-life. 76% of patients have resistance to at least one drug with HAART. There has been no drug resistance in patients identified in patients taking Leronlimab in monotherapy for over 4 years.
CytoDyn has successfully completed a Phase 3 pivotal trial with Leronlimab in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients meeting its primary endpoint. 81% of patients completing trial achieved HIV viral load suppression of < 50 cp/mL. Recent approved drugs for this population range from 43% after 24 weeks to 45% after 48 weeks with viral load suppression of < 50 cp/mL.
CytoDyn has submitted the first section (non-clinical) of its Biological License Application (BLA) for that indication and our team is working diligently on the remaining two portions of the BLA (clinical, CMC). The FDA previously granted Fast Track Designation (FTD) and recently granted Rolling Review for Leronlimab (PRO140), which facilitates frequent interactions with the FDA review team. The Rolling Review process allows CytoDyn to submit individual sections of the BLA for review, rather than waiting on FDA review until all three sections are completed and filed.
CytoDyn is also conducting an investigative monotherapy trial for HIV. In addition, the Company has filed with the FDA a pivotal trial protocol for Leronlimab as a monotherapy. If the protocol is accepted and the trial is successful, it would represent a true paradigm shift in the way HIV is currently treated.