Cytodyn Inc (CYDY)

[JPG77]

CytoDyn Submits Protocol with the FDA for Phase 3 Registrational Trial of Leronlimab for Critically Ill COVID-19 Population

During recent discussions with the FDA, the agency suggested that developing leronlimab for critically ill COVID-19 patients in current situation in U.S. appears feasible

VANCOUVER, Washington--(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 announced that it has submitted a Phase 3, randomized, double blind, placebo controlled trial with the U.S. Food and Drug Administration (“FDA”) to evaluate the efficacy and safety of leronlimab in combination with standard of care for critically ill patients with COVID-19 pneumonia with need for invasive mechanical ventilation ("IMV”) or Extracorporeal Membrane Oxygenation (“ECMO”).

In CytoDyn’s recent discussions with the FDA regarding potential marketing approval of leronlimab for critically ill COVID-19 population, the agency stated: “While there are currently fewer U.S. patients hospitalized for COVID-19 daily in the U.S. compared to when you submitted your initial request for an expanded access protocol in August 2021, the CDC reports that 38,332 patients were hospitalized daily in the U.S. during the week of November 7th-13th, 2021. In this context, conducting a clinical trial in the U.S. that could support marketing approval of leronlimab for the treatment of critically ill patients with COVID-19 appears feasible.”

If approved by the FDA, patients in this trial will be randomized in a 1:1 ratio to receive up to four doses of 700 mg leronlimab with standard of care or placebo with standard of care administered by 30-minute IV infusion weekly over a four-week treatment period.

The subgroup analyses of 62 critically ill patients in the past Phase 3 CD12 trial for severe-to-critically ill population in the U.S. showed an 82% survival benefit at Day 14 after two doses of leronlimab on Day 0 and Day 7 (Odd Ratio 0.09 (CI 0.01, 0.72), p-value 0.0233) vs. standard of care plus placebo. The survival benefit fell from 82% to 30% after four weeks.

Nitya Ray, Ph.D., CytoDyn’s Chief Operating and Technology Officer, commented, “We expect further improvement in survival benefit in the new study with four weekly doses of leronlimab delivered by IV infusion. With IV dosing, the bioavailability and peak serum concentration of leronlimab will be much better compared to subcutaneous (“SC”) dosing. Furthermore, while the maximum serum concentration is achieved in less than two hours for IV infusion, it takes two to three days to reach the peak concentration in a SC setting. This is crucial in our view, especially for the critically ill patients who are on IMV or ECMO when every moment counts.”

Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer, commented, “Entering Phase 3 of the developmental trial is an exciting opportunity as we further explore leronlimab’s viability as a treatment option for critically ill COVID-19 patients. We are optimistic that the new trial with 4 dosages of leronlimab instead of the previous trial with 2 dosages will have much better outcome. We are very proud of our COVID-19 development team conducting two Phase 3 trials in Brazil while pursuing two more in the U.S. (critically ill and long-haulers). We have worked very hard to place our Company in a solid position in areas of HIV, Cancer, NASH, and COVID-19 and 2022 we believe will be a great year for us.”