FDA Provides Guidance for Adding an Open-Label Extension to CytoDyn’s Phase 3 Trial for Severe-to-Critical COVID-19 Patients Until Trial Data is Unblinded
The agency will also consider eINDs for patients in other hospitals who qualify for inclusion criteria similar to CD12
The CD12 trial completed enrollment with 394 patients on December 16
VANCOUVER, Washington, Dec. 24, 2020 (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 the U.S. Food and Drug Administration (“FDA”) provided guidance to the Company to add an open-label extension to its Phase 3 trial (“CD12”) and specific criteria for the continuation of eINDs for patients meeting the inclusion/exclusion criteria of CD12.
The CD12 protocol will be amended for adding the open-label arm extension and submitted to the FDA on Monday, December 28, 2020. Upon clearance, each CD12 participating clinical trial site will have the option of enrolling additional qualified patients, with all patients receiving leronlimab. Treatment of qualified patients will continue until the trial’s data is unblinded.
The FDA also provided specific guidance for the benefit of physicians seeking an eIND for COVID-19 patients, which must first meet the inclusion/exclusion criteria of the CD12 study, and such criteria will be provided to them in the form of a checklist.
Mahboob Rahman, M.D., Ph.D., Chief Scientific Officer and Head of Clinical Development for CytoDyn, stated, “We are pleased that at a time when COVID-19 cases and mortality continue to increase, the FDA’s thoughtful advice will allow a specified subset of patients access to leronlimab, while we await the results of the randomized placebo-controlled portion of the Phase 3 study. We are committed to work with the FDA and the health care providers to improve the outcomes of COVID patients.”
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented, “We are very thankful to the FDA for providing guidance on accessing our drug pending the results of CD12, especially during these unprecedented times. CytoDyn will provide the precise requirements for potential participation in the new CD12 open-label extension and physicians seeking eINDs, while we eagerly await the unblinding of the data. The results of our CD10 trial will not support an eIND request.”