Regeneron and Sanofi provided interim update in randomized phase 2/3 trial of Kevzara, and IL6-inhibitor. They decided moving forward to focus only on critical patients in phase 3 part of the trial, and eliminate the low dose arm and only keep the high dose arm.
This is being portrayed in media headlines as negative, but as can be seen from the preliminary results below, the high dose does pretty darn good. It clearly reduces the change from baseline in C-reactive protein, the biological endpoint, but look at the other clinical endpoints in the clinical group. Compares with placebo, 1/3 the level on ventilator, 40%+ showing clinical improvement and off oxygenation, and 30%+ greater discharge rate. These are secondary endpoints, but promising, and these will become key endpoints in the revised phase 3 study.
Good example of how we have to look past the headlines, and also the importance of recognizing the specific medical setting, in this case advanced patients at risk of acute respiratory syndrome (ARS) induced by cytokine storm, is important to consider depending on the mode of operation of the specific drug.