Following an internal pipeline review, Santhera has decided to discontinue development of omigapil. We know this news is discouraging, especially for those of you who sacrificed so much to participate in the phase I study.
In partnership with our fellow advocacy organizations, researchers, and industry, Cure CMD will make every effort to identify an alternative path forward for the omigapil program in CMD.
We have and will continue to prioritize the development of treatments and clinical trial readiness for the CMD community.
The NIH team is working on a publication summarizing results of the CALLISTO study. This publication will highlight the successful recruitment and completion of a phase I clinical trial in CMD, lessons learned -- including the need for all patients to receive the standard level of care at the time of enrollment -- and which outcome measures are feasible for assessing potential efficacy in COL6 and LAMA2-RD. This publication will lay the foundation for future CMD clinical trials.
We will be in touch with any future developments.
On behalf of Cure CMD’s Board of Directors and Scientific Advisory Board,