CytoDyn Announces Clinically Significant Top-line Results from its Phase 2 Trial in Mild-to-Moderate COVID-19 Patients
Primary endpoint shows early clinical improvement in symptom score at Day 3 in patients receiving leronlimab
Leronlimab also demonstrated statistically significant improvement versus placebo in key secondary efficacy endpoint, National Early Warning Score 2 scale (NEWS2)
Results will be reported to the United States FDA, United Kingdom MHRA, and European Union regulatory agency, EMA
Management to hold conference call on August 12 at 1:00 pm PT - - details to follow
VANCOUVER, Washington, Aug. 11, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company announced today the Top-line results from its recently completed, randomized, double-blind, Phase 2 trial for COVID-19 patients with mild-to-moderate symptoms. CytoDyn will submit its Top-line Report for this trial to the U.S. Food and Drug Administration for review later this week. The Top-line Report revealed the following information:
Clinical improvement assessed by change in total clinical symptom score:
In patients with Total Clinical Symptom Score of ≥ 4 at baseline (higher scores equate to poorer health state): At Day 3, more subjects treated with leronlimab reported improvement in total clinical symptom score compared to the placebo group (90% on leronlimab arm vs. 71% on placebo). The subgroup analysis indicates that among patients with more symptoms at baseline, those who received leronlimab had a greater treatment effect than patients who received the placebo.
The National Early Warning Score 2 (NEWS2):
The National Early Warning Score (NEWS) is an objective scale developed by the Royal College of Physicians to identify patients at risk for rapid clinical deterioration requiring critical care intervention. NEWS2 (the latest version), is being used as an endpoint in several other COVID-19 clinical trials, including CytoDyn's severe-to-critical COVID-19 Phase 3 trial. It measures clinical parameters including respiratory rate, oxygen saturation, supplemental oxygen, temperature, systolic blood pressure, heart rate, and level of consciousness. In all treated patients, at the End of Treatment (or Day 14), patients in the leronlimab group were more than twice as likely to experience a beneficial improvement in scores compared to patients in the placebo group (50% vs 20%; p=0.0223).