Aclaris Therapeutics Inc. (NASDAQ: ACRS) says it has received an update from the U.S. Food and Drug Administration (FDA) indicating that the agency has allowed an investigational New Drug Application (NDA) to evaluate ATI-450 in hospitalized patients with COVID-19. Shares jumped on Wednesday in response to the news.
Aclaris is supporting an investigator-initiated trial of ATI-450 for cytokine release syndrome (CRS) in 36 hospitalized patients with COVID-19, and it will provide funding and clinical drug supply to the University of Kansas Medical Center (KUMC), the sponsor of the trial.
This is a Phase 2a randomized, double-blind, placebo-controlled trial that will investigate the safety and efficacy of ATI-450 when used in addition to standard of care therapy. Also, the primary endpoint is the proportion of subjects who are free from respiratory failure by day 14.
Previously, ATI-450 has been observed to regulate pro-inflammatory cytokines associated with CRS.
Dr. David Gordon, chief medical officer of Aclaris, noted that inhibiting multiple cytokines has the potential to achieve clinical benefits in patients with CRS, and this study will explore if ATI-450 is an effective approach in these patients. Gordon was quick to thank KUMC for sponsoring the trial.
Gordon also noted that if the trial is successful, Aclaris hopes to explore further the role that ATI-450 may have in helping patients with COVID-19, as well as addressing the health care challenges of the pandemic.
Aclaris Therapeutics stock traded up about 33% at $1.97 Wednesday morning, in a 52-week range of $0.70 to $5.37.