Catabasis Pharmaceuticals has shared an update responding to questions about edasalonexent and COVID-19. To date, Catabasis has not identified any safety concerns related to COVID-19, and they continue to monitor the trial for the safety of the participants.
Read the update from Catabasis:
As we are all faced with a situation that we couldn’t imagine, we have been receiving questions about edasalonexent and COVID-19 and are providing additional information.
‣ PPMD has provided guidelines on general care: https://www.parentprojectmd.org/update-on-coronavirus-reco…/
PPMD commented on the risk for those with Duchenne: “As people with Duchenne are immunocompromised (if on steroids) and have heart and lung problems, this puts them at a higher risk.” In the Phase 3 PolarisDMD Trial of edasalonexent as well as the GalaxyDMD open label trial, boys are not on steroids.
‣ What we know about edasalonexent is that long-term toxicology studies of edasalonexent at doses that have exposures that exceed those in the clinic have found no evidence for immunosuppression using standard clinical and anatomic physiology methods. We have not found any evidence of immunosuppression or increased infections in clinical studies, now with over 100 patient-years of exposure to edasalonexent.
‣ As always, we are closely monitoring the trial for the safety of the participating boys. To date, we have not identified any safety concerns related to COVID-19. We recommend reviewing local recommendations to reduce risk for boys and their families.