CytoDyn’s COVID-19 Long-Hauler’s Trial Closed as Enrollment Exceeds Goals
VANCOUVER, Washington, April 08, 2021 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with potential multiple therapeutic indications, announced today its COVID-19 long-haulers study (“CD15”) is now fully enrolled. Enrollment was faster than expected because of the high number of patients wanting to participate, which now includes 56 patients in the trial. This is a multicenter Phase 2, two-arm, randomized, double blind, placebo-controlled study to evaluate the safety and efficacy of Vyrologix (leronlimab) in the treatment of patients with prolonged COVID-19 symptoms, a condition now known as Post-Acute COVID Syndrome (PACS). Patients will be given eight (8) weekly doses of Vyrologix or placebo. The final treatment for the last enrolled patient will be in early June with results expected in July.
Chris Recknor, M.D., CytoDyn’s Chief Operating Officer and Head of Clinical Development, said, “These patients have been suffering from COVID-19 symptoms for more than 12 weeks, many for more than 6 months. After reviewing the results from our earlier CD10 trial involving patients with mild-to-moderate COVID-19, we recognized Vyrologix may be a solution to PACS and have since developed a better understanding of the mechanism of action and how Vyrologix works in PACS. We believe CytoDyn is now well positioned to potentially be the first to offer an effective treatment for this condition where no other therapy is currently available.”
Scott Kelly, M.D., Chief Medical Officer and Head of CytoDyn’s Business Development, added, “PACS is rapidly evolving into a global health emergency. At the current rate of COVID-19 infections, global cases are expected to exceed 200 million by the end of 2021. It is estimated 10-30% of those infected will have persistent symptoms, leaving 20 to 60 million patients without effective treatment options. PACS is devastating to patients’ quality of life, and its economic impact is ruinous. PACS shares many features of Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME), and approximately 50-75% of CFS/ME patients are unable to work or attend school. If Vyrologix is successful in treating PACS, then trials in other post-viral syndromes will be the logical next step.”
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