On September 28, 2023, Regeneron published the results of their Phase 2 LUMINA-1 Clinical Trial of the drug garetosmab in Nature Medicine, a peer-reviewed publication.

Regeneron also published clinical pharmacology results from the LUMINA-1 Trial in the Journal of Clinical Pharmacology.

Also on September 28, Vanderbilt University Medical Center, one of the sites for the LUMINA-1 Trial, issued this press release announcing the peer-reviewed publication of Phase 2 results and sharing the story of Sharon Kantanie, a trial participant.

The IFOPA is grateful to the 44 individuals with FOP who enrolled in the LUMINA-1 Phase 2 Trial, including the five community members who passed during the open-label period. The willingness of families to participate in clinical trial research is the only way we will ever learn if drugs are safe and effective treatments for FOP. We also appreciate the work of the trial investigators and their commitment to FOP families. We are also grateful to Regeneron for their commitment to the FOP community and the development of garetosmab.  

The investigation of garetosmab as a treatment for FOP has now moved forward in the Phase 3 OPTIMA trial. You can learn more at ifopa.org/regn2477. 

Questions about these publications or the Regeneron trial? Contact us at [email protected]