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).
Similar, statistically significant, results were observed at Day 3 and Day 14 in the analysis of per protocol population (p<0.03 and p<0.02, respectively).
Safety Endpoints:
The incidence, frequency, and severity of adverse events (AEs) and serious adverse events (SAEs) were lower in the leronlimab group compared to the placebo group. Patients treated with placebo were more than twice as likely to experience SAEs or AEs compared to patients treated with leronlimab.
Harish Seethamraju, M.D., Lead Principal Investigator at Montefiore Medical Center NY, stated, “The results demonstrate that CCR5 blockade by leronlimab given as a weekly subcutaneous injection in mild-to-moderate COVID-19 patients is reasonably safe and associated with rapid improvement in viral symptoms with fewer adverse events than when compared to placebo.”
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, “In the mild- to-moderate population, it is important to have a therapeutic option for COVID-19 in patients who are showing signs of rapid clinical deterioration. Patients receiving leronlimab showed a statistically significant improvement using NEWS2 clinical parameters. We will make a case for immediate approval of leronlimab for this population of COVID-19 patients, not only in the U.S., but in the U.K. and other countries around the world.”
Scott A. Kelly, M.D., Chief Medical Officer of CytoDyn, said, “We are thrilled with the results of leronlimab in mild-to-moderate COVID-19 patients. It is paramount to determine which patients will deteriorate and require critical care interventions, including patients at risk for ICU admission, cardiac arrest, or death within 24 hours. The NEWS2 aims to identify those patients most at risk. We are pleased that leronlimab showed a statistically significant result in a randomized, double-blinded study for NEWS2. The decreased probability in serious adverse events, as well as overall adverse events with leronlimab compared to placebo further supports the use of leronlimab as a treatment option for COVID-19.”
Jacob P. Lalezari, M.D., Senior Science Advisor to CytoDyn, said, "Treatment with leronlimab demonstrated reductions in both serious adverse events, as well as predictors of pulmonary collapse in patients with mild-to-moderate COVID-19. We initiated the study hoping to reduce flu-like symptoms, such as fever, cough, and muscle aches. In the end, use of leronlimab was not only correlated with improved symptom scores in patients with measurable symptoms at baseline, but also provided significant and consequential benefits on far more serious endpoints. Demonstrating these efficacy signals in a population with mostly mild illness at study entry bodes well for leronlimab’s activity in patients with more severe illness.”
