To the STXBP1 Community:
It is with heavy hearts that we share that the first patient to participate in our SYNRGY trial for STXBP1-Related Disorders passed away. We wish to express our deepest condolences to the patient’s family and know that the entire community is grieving this loss.
We understand this devastating news will raise questions and uncertainty, and we are working with urgency to gather information and find answers. We have voluntarily paused the CAP-002 SYNRGY study while we determine the root cause of the patient’s passing. As we continue to work closely with our partners and relevant experts, we have alerted the FDA and will be providing them with a full report in compliance with regulations. Once this work is complete, we can begin to assess next steps with respect to this important program.
We are committed to keeping the community informed about what happened and our plans for the program as soon as we have information to share.
We understand that a letter will not ease the pain you are all feeling, but we want you to know we are mourning together with the patient’s family and all of you. We are committed to timely and transparent communication with the STXBP1 community.
Sincerely,
The entire Capsida Biotherapeutics team