La Force is happy to share the latest edition of the Catabasis Connection newsletter. As we are all faced with an unimaginable situation, Catabasis wanted to reach out and share information in response to questions they have been receiving about edasalonexent and COVID-19.
Catabasis is monitoring the trial for the safety of participating boys. To date, they did not identify any safety concerns related to COVID-19. We encourage reviewing your local recommendations to reduce the risk for boys and their families, and please consult your physician regarding specific medical advice. > Catabasis Connection <
Does edasalonexent affect the immune system?
Long-term toxicology studies with edasalonexent using higher doses than those in their clinical trials have found no evidence for immunosuppression using standard clinical and anatomic physiology methods. In clinical studies, now with over 100 patient-years of exposure to edasalonexent, Catabasis has found no evidence of immunosuppression or increased infections. In the Phase 3 PolarisDMD trial of edasalonexent, as well as the GalaxyDMD open-label trial, boys are not on steroids.
Should trial participants still go to the hospital for their assessments?
They are fortunate that site visits are relatively infrequent during the Phase 3 PolarisDMD trial with assessments every 3 months. Currently, they are focused on ensuring that patients have uninterrupted drug supply as well as safety monitoring. Catabasis is working closely with its clinical trial sites with frequent communication.
Will the outcome of ongoing trials be endangered by not being able to carry them out as per protocol?
Catabasis is actively monitoring the situation and has plans in place to address potential disruptions. Fortunately, they designed their clinical trial so that visits are relatively infrequent. Catabasis is working with sites to support drug supply, as well as safety and efficacy assessments.
About Catabasis
The mission of Catabasis Pharmaceuticals is to bring hope and life-changing therapies to patients and their families. There lead program is edasalonexent, an NF-kB inhibitor in Phase 3 development for the treatment of Duchenne muscular dystrophy. For more information on edasalonexent and the Phase 3 trial, please visit www.catabasis.com.
- Watch this video recorded in November 2016, Dr. Joanne Donovan answers our questions about edasalonexent (CAT-1004)
- Learn more about PolarisDMD clinical trial
- Join Catabasis mailing list
- CatabasisPharma on Facebook, Twitter and Instagram if you are interested in the latest updates
About La Force DMD
The Force’s mission is to unite the DMD community to raise awareness around a common objective: that of providing access to new treatments as fast as possible and to participate in the funding of promising research projects. Where access to treatments for rare diseases is concerned, it is essential that our community be strong: each member must be an active spokesperson who helps raise awareness for DMD among the general public, as well as for the challenges associated with access to treatment.
Edasalonexent is an investigational drug that is not yet approved in any territory.
