CytoDyn to File Accelerated Rolling Review with MHRA and Interim Order (IO) with Health Canada for COVID-19
U.S. FDA Reviewing Protocol for More COVID-19 Critical Patients to be Enrolled to Support Potential EUA
CytoDyn submitted protocol to U.S. FDA for immediate enrollment of 140 critical COVID-19 patients with same sites as CD12 trial – enrollment to commence upon FDA comments
VANCOUVER, Washington, March 08, 2021 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing Vyrologix (leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today multiple regulatory pathways for approval of leronlimab as a treatment for critical COVID-19 patients in the U.S., U.K. and Canada.
MHRA has told the Company it will accept more data from the open-label portion of the current CD12 trial. To date, an additional 46 patients have been enrolled, but the results have not yet been communicated to any agency.
The Company anticipates the Health Canada Interim Order (IO) could allow the Company to sell leronlimab in Canada, while additional critical COVID-19 patients are enrolled. These discussions are on going, and the Company has initiated the process to submit an IO with Health Canada.
The Company also confirms the U.S. FDA has received its protocol for enrolling 140 critically ill COVID-19 patients with the primary endpoint defined as length of hospital stay.
CytoDyn is pleased to show strong data for critically ill COVID-19 patients. Considering the fact that:
(1) A higher proportion of patients over 65 were enrolled in the leronlimab arm (33%) compared to the placebo arm (23%), and
(2) Of the 384 treated patients, 117 were over 65 with an overall mortality rate 3.5 times higher (42% - 49/117) than for patients under 65 (12% - 31/267).
Therefore, an “age adjustment” analysis was performed and consequently, the updated results from the primary endpoint analysis are as follows:
1) Statistically significant results (p-value = 0.0319) reported for the primary endpoint (all-cause mortality at Day 28) in participants receiving leronlimab + “commonly used COVID-19 treatments” compared to participants who received “commonly used COVID-19 treatments” alone in the placebo group in the overall modified intent-to-treat (“mITT”) population.