CytoDyn: FDA Provides Guidance For Adding Open-Label Extension To Phase 3 Trial CD12

(RTTNews) - CytoDyn Inc. (CYDY) said the 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. CytoDyn completed enrollment of 390 patients in its phase 2b/3 randomized clinical trial for the severe-to-critically ill COVID-19 population and expects to release results in mid-January 2021.

CytoDyn said the CD12 protocol will be amended for adding the open-label arm extension and submitted to the FDA on 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.

Mahboob Rahman, Chief Scientific Officer, stated, "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."