Recursion’s message to our patients regarding the discontinuation of the REC-994 trial:
We have difficult news to share today. Recursion has made the decision to discontinue the SYCAMORE trial of REC-994, a treatment for Symptomatic Cerebral Cavernous Malformation. We understand this news may be disappointing, and we want to explain why this decision was made.
Early data from the trial, after patients had been on REC-994 for one year, suggested some promising trends with the 400mg dose. However, these positive trends were not sustained in the long-term extension of the trial, whether patients stayed on the 400mg dose, switched from the 200mg dose to 400mg, or most importantly those who were switched from the placebo (no active treatment) to 400 mg dose for the long term extension.
Further analysis of the long-term extension data showed that there were no significant improvements in MRI results or functional outcomes. The results were unfortunately similar to what we might expect without any treatment. The decision to discontinue the trial was made after a thorough review of all the data, especially the long-term results.
If you were participating in the trial, your study team will be reaching out to you very soon to discuss your individual situation and next steps. We know this is not the outcome we all hoped for, and we sincerely share in your disappointment that REC-994 did not prove to be the treatment we needed. However, we want to emphasize that the research conducted by Recursion and participation by many patients in the CCM community is invaluable and contributes to our overall understanding and search for a cure.
Chris Gibson, Recursion’s CEO, shared the following:
“This program has always held a special place in Recursion’s history. CCM was the first area we explored using AI-driven drug discovery, and the community impacted by this disease is one we deeply care about. We understand this is disappointing news for the CCM community and for us. We are deeply grateful to all the patients and families who participated in these trials. Our commitment to finding solutions for unmet medical needs remains strong, and what we have learned from the REC-994 program will guide our future research and efforts to find effective treatments for patients.”
From the Alliance to Cure Cavernous Malformation:
How did the REC-994 trial advance CCM science?
We know that the vast majority of drugs tested in clinical trials do not end up becoming approved treatments, but clinical trials are a necessary part of drug development. Even though the REC-994 trial did not end in an approved treatment for CCM, it did get us closer to a cure. We now have the infrastructure, tools, and know-how to run CCM clinical trials in the future. We are immensely grateful to the volunteers who participated in the REC-994 trial and moved CCM research forward.
What are our next steps for CCM research?
The REC-994 trial discontinuation does not affect our mission to drive a cure for CCM. We continue to move critical research projects like the following forward:
- speeding up drug development by testing compounds in our CCM CureDriver Lab
- planning a clinical safety trial of focused ultrasound
- working with researchers on gene therapy and targeted drug-delivery.
