CYD - CytoDyn to amend Phase 3 trial protocol for COVID-19 therapy

CytoDyn (CYD) has announced that the FDA has issued guidance to add an open-label extension to its Phase 3 trial (CD12) for Vyrologix™ (leronlimab-PRO 140) in severe-to-critically ill COVID-19 patients, including specific criteria for the continuation of eINDs for patients meeting the inclusion/exclusion criteria of CD12.The company expects to amend the trial protocol and seek FDA submission on December 28. Upon regulatory clearance, the trial sites will have the option of enrolling additional qualified patients who will undergo the treatment until the trial’s data is unblinded.The CEO of CytoDyn said the company will specify the requirements for the open-label extension study and physicians seeking eINDs, adding that the results of the CD10 Phase 2 clinical trial will not support an eIND request.Earlier, the Phase 2 clinical trial (CD10) generated positive results, and the Phase 3 randomized trial completed the enrollment on December 16, with results expected in mid-January 2021.

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CytoDyn to amend Phase 3 trial protocol for COVID-19 therapy