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.
To support the understanding of these results by FOP families, a graphical plain language summary of the results was published in Future Medicine on April 11, 2024. Translated versions of the Plain Language Summary will be available soon. Watch for an announcement from the IFOPA.
“The LUMINA-1 study showed that in people with FOP, garetosmab stopped new heterotopic bone from developing in areas that it should not and also reduced flare-ups. This shows that garetosmab may be a useful treatment for people with FOP. More testing is needed to better understand the benefits and risks of garetosmab.”
In November 2022, Regeneron opened OPTIMA, a Phase 3 trial of the drug garetosmab. More information is also available at optimatrial.com