Pause in Dosing for the LUMINA-1 FOP Clinical Trial

Dear FOP community,
 
Recently, Regeneron announced that the dosing of garetosmab, an investigational drug for FOP, has been paused. While we are disappointed to see this pause, we believe Regeneron is taking the necessary steps to assess whether the observed deaths in the Phase 2 LUMINA-1 trial are related to garetosmab. To date, no conclusion concerning the relatedness of these deaths to garetosmab has been made. 
 
Developing drugs for any disease is a long and risky endeavor, and many investigational drugs do not become approved medicines for a variety of reasons. It is therefore essential that we recognize clinical trials not as treatments, but research studies conducted to determine whether a drug is both safe and effective. When safety concerns are raised during a drug’s development, it is important that researchers, investigators, and regulators take the necessary time and steps to assess whether its safe for patients to continue in the trial. Currently, we do not know the timetable for evaluating the potential safety concerns observed in the LUMINA-1 trial.
 
Irrespective of this evaluation, the IFOPA remains committed to funding research and development of new treatments for FOP, and eventually a cure. And we remain steadfast to this mission.
 
If you would like to read more about the dosing pause for the LUMINA-1 trial, please see Regeneron’s press release. If you are a patient currently enrolled in the LUMINA-1 trial and have any questions or concerns, please contact your trial investigator. If you would like to learn more about drug development and clinical trials, please visit the IFOPA’s clinical research website.
 
We will provide further updates as we learn more. In the meantime, please let the IFOPA know if you have any additional questions by sending an email to together@ifopa.org.

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