CytoDyn Files Protocol with U.S. FDA for Phase 2 Clinical Trial for COVID-19 Patients with Long-Hauler Symptoms
Rapid Enrollment Expected, As Many People Have Already Volunteered
VANCOUVER, Washington, Nov. 17, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today it has filed a protocol with the U.S. Food and Drug Administration (FDA) for a Phase 2 clinical trial for leronlimab as a treatment for COVID-19 patients suffering from long-hauler symptoms.
According to a recent article from The Journal of the American Medical Association and a study done by British scientists, researchers estimate about 10% of COVID-19 patients become long-haulers. Published studies and surveys conducted by patient groups indicate 50% to 80% of patients continue to have troublesome symptoms three months after the onset of COVID-19 — even after tests no longer detect virus in their body. The list of long-hauler symptoms is extensive and inconsistent. For some people, the lingering symptoms are nothing like the original symptoms when they were first infected with COVID-19. The most common long-hauler symptoms include:
- Ongoing, sometimes debilitating, fatigue
- Body aches
- Joint pain
- Heart issues
- Shortness of breath
- Loss of taste and smell
- Difficulty sleeping
- Brain fog
CytoDyn’s protocol for its Phase 2 COVID-19 long-haulers trial is entitled: ”A Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Leronlimab in Patients Experiencing Prolonged Coronavirus Disease 2019 (COVID-19) Symptoms [Long-Haulers].” The planned number of patients is 102 to be enrolled in up to 10 sites. The study will have an interim analysis after half of the patients are enrolled and will allow CytoDyn to report the results.
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented, “We are very pleased to be able to finalize this protocol and submit today. Many thanks to Drs. Chris Recknor, Mahboob Rahman and Kush Dhody for spending countless hours over the last six weeks finalizing this very challenging trial protocol. Dr. Recknor’s past enrollment of patients in our CD10 trial was critical to his understanding of what leronlimab can do and his experience with those patients greatly assisted us to design and finalize this protocol. If successful, this Phase 2 trial could potentially allow leronlimab to be the first treatment for patients experiencing these debilitating symptoms and perhaps their only hope for full recovery. We have become very knowledgeable of leronlimab’s potential for COVID-19 patients due to our completed Phase 2 trial for mild-to-moderate symptoms, for which a complete report has been submitted to a very reputable journal for publication.”