CytoDyn gets regulatory clearance for protocol change in COVID-19 trial

 

• CytoDyn (OTCQB:CYDY) has announced that the FDA has accepted its amended protocol for adding an open-label extension to its Phase 3 trial (CD12) for Vyrologix™ (leronlimab-PRO 140) in severe-to-critically ill COVID-19.
• Last week, the company said it was on track to submit the amended protocol to the FDA on December 28, and upon regulatory clearance, each CD12 participating clinical trial site would have the option of enrolling additional qualified patients, with all patients receiving leronlimab.
• For physicians seeking access to leronlimab under an eIND for COVID-19 patients, the agency has issued specific guidance with the eIND first required to meet the inclusion/exclusion criteria of the CD12 study.
• Several patient subgroups will be excluded from eIND authorization: those with mild/moderate COVID-19, mechanically ventilated with PEEP <15 cmH20 with Pa02/FiO2 >150 mmHg, and on vasopressors >48 hours.
• Meanwhile, a research manuscript, the results of which were based on four critically ill COVID-19 patients treated with leronlimab under eIND, has also been accepted for publication in the Journal of Translational Autoimmunity.
• Noting that all four patients covered in the paper were on a mechanical ventilator and fully recovered, Nader Pourhassan, the CEO of CytoDyn called the publication submitted by Nicholas J. Agresti M.D., “as a validation of leronlimab as an important potential therapeutic in the treatment of seriously ill COVID-19 patients.”
• The clinical development of Leronlimab-PRO 140, a CCR5 antagonist with the potential for multiple therapeutic indications, will be the subject of a webcast scheduled by the company for January 06.
• https://seekingalpha.com/news/3648085-cytodyn-gets-regulatory-clearance-for-protocol-change-in-covidminus-19-trial