Roivant Provides Updates for Pivotal BREATHE Clinical Trial Evaluating Gimsilumab in COVID-19

Roivant Sciences today announced several updates for its adaptive, randomized, double-blind, placebo-controlled, multi-center pivotal BREATHE trial evaluating the impact of intravenous (IV) treatment with gimsilumab on mortality in COVID-19 patients with lung injury or ARDS. The independent Data Monitoring Committee (DMC) for BREATHE unanimously recommended that the trial continue after a pre-specified safety assessment evaluating data from the first 10% of randomized subjects after six days of follow-up. In addition, Roivant recently amended the protocol to permit the use of investigational antivirals (e.g. remdesivir) during the study, as well as treatment with convalescent plasma prior to enrollment. 56 patients have been enrolled in the study to date, and a total of 7 sites have been initiated in New York, Philadelphia, Detroit, New Orleans, Dallas, and Atlanta. "We are pleased with the rapid progress we have made to date on the BREATHE program. The adjustments to our protocol reflect our desire to ensure patients receive the best possible treatment.  We believe gimsilumab may prove to be complementary with antivirals and convalescent plasma and anticipate providing a definitive answer to the question of whether an anti-GM-CSF antibody can provide benefit to COVID-19 patients," said Simon Lowry, MD, the program's lead.