FDAnews
www.fdanews.com/articles/196693-cytodyn-doses-first-patient-in-phase-2b3-trial-of-leronlimab-for-covid-19

CytoDyn Doses First Patient in Phase 2b/3 Trial of Leronlimab for COVID-19

April 16, 2020

CytoDyn’s phase 2b/3 trial of its investigational drug leronlimab as a COVID-19 treatment got underway yesterday.

The company has enrolled 15 participants in its phase 2b trial for patients with mild-to-moderate COVID-19 infections.

The trial will be expanded to include 390 patients.  The company said it will issue an interim analysis on the data from 50 patients.

Leronlimab, which is under investigation for treatment of HIV and breast cancer, has been administered to more than 30 COVID-19 patients under an emergency investigational new drug application.

The FDA granted the drug a fast-track approval for HIV and breast cancer. The drug has also received an orphan drug designation for preventing graft-vs.-host disease. — Jordan Williams