UPDATE - Impressive Results From CytoDyn’s Phase 2 COVID-19 Trial

39% (11 SAEs in 28 Patients) in Placebo Arm as Compared to Only 14% (8 SAEs in 56 Patients) in Leronlimab Arm Reported Serious Adverse Events (SAEs), Which Were Unrelated to Leronlimab. The Efficacy Portion of the Trial Will Be Announced Along With a Full Report as Soon as Statistical Analyses Are Completed

Evaluation of safety data indicates the following:

• Leronlimab: 5 patients out of 56 (about 9%) reported serious adverse events, none were related to leronlimab
   
• Placebo: 6 patients out of 28 (about 21%) reported serious adverse events

VANCOUVER, Washington, July 21, 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 the results of the patient safety data from the Company’s over-enrolled COVID-19 Phase 2 trial for mild-to-moderate indications. 

A total of 84 patients were treated across 8 study sites in the randomized, double-blind, placebo-controlled Phase 2 study. Fifty-six (56) patients were assigned to the leronlimab arm compared to 28 patients in the randomized placebo arm with a 2:1 active drug to placebo ratio. This trial was designed to evaluate the safety and efficacy of leronlimab and the results of efficacy portion of the data is anticipated to be released as soon as the statistical analyses of all primary and secondary endpoints are completed.  

In this Phase 2 study, 34% (19 of 56 patients) treated with leronlimab compared to 50% (14 of 28 patients) treated with placebo reported at least one adverse event. A total of 19 serious adverse events (SAEs) were reported during the study. Eleven (11) SAEs were reported in 6 patients (6/28; 21.4%) receiving placebo compared to eight (8) SAEs in 5 patients (5/56; 8.9%) receiving leronlimab. None of the SAEs in the leronlimab arm were deemed related to study drug administration by the investigators. Of the 84 patients treated, one patient died 33 days after enrollment due to an event unrelated to leronlimab.

Scott Kelly, M.D., CytoDyn’s Chief Medical Officer, commented, “We are very pleased with the safety results in the double-blinded, placebo-controlled study of the mild-to-moderate COVID-19 population. When considering treatment options in the COVID-19 population, it is paramount in treating this complex disease to provide patients with therapeutic options that minimize SAEs. We believe the significant reduction in SAEs in the leronlimab group ultimately translates into improved patient clinical outcomes. Prior drugs in clinical trials for the treatment of COVID-19 have resulted in an increase in SAEs in the drug treated arm versus placebo. We are extremely proud of these results.“