In August, Regeneron Pharmaceuticals shared an update on the LUMINA-1 Clinical Trial which was placed on clinical hold by the FDA in October 2020. Today we are pleased to share a follow-up letter from the team leading the FOP clinical program and patient advocacy at Regeneron.
This letter provides more insights into the serious adverse events that were reported during the Phase II LUMINA-1 trial, the development of a phase III trial for garetosmab, the closure of the LUMINA-1 trial, compassionate use of garetosmab, and the publication of data from the LUMINA-1 trial.
As we share information about the continued testing of garetosmab as a potential treatment for FOP, we want to thank and recognize each person that volunteered to participate in the LUMINA-1 trial. Without patients willing to participate in trials, potential drug treatments cannot be tested for safety and efficacy in people living with FOP.
If you have additional questions regarding your participation in a clinical trial, please consult your physician.