Recursion’s SYCAMORE trial meets primary endpoint of safety and demonstrates encouraging trends in objective MRI-based exploratory efficacy measures
SALT LAKE CITY, Sept. 03, 2024 (GLOBE NEWSWIRE) — Recursion (NASDAQ: RXRX), a leading clinical stage TechBio company decoding biology to radically improve lives, today announced top-line results of the SYCAMORE trial, a 12-month Phase 2 randomized double-blind, placebo-controlled, safety, tolerability and exploratory efficacy study for REC-994 in symptomatic CCM patients.
REC-994 met its primary endpoint of safety and tolerability, demonstrating a similar profile across placebo and both 200mg and 400mg dosage-arms with regard to the frequency and severity of adverse events after 12 months of treatment. Magnetic resonance imaging-based secondary efficacy endpoints showed a trend towards reduced lesion volume and hemosiderin ring size in patients at the highest dose (400mg) as compared to placebo. Time-dependent improvement in these trends at the 400mg dose was also observed in this signal-finding study. Improvements in either patient or physician-reported outcomes were not yet seen at the 12 month time point. A meeting with the FDA is anticipated as soon as practical to discuss plans for an additional clinical study. Recursion plans to present data from this trial at a forthcoming medical conference and intends to submit these data for publication in a peer reviewed scientific journal. Read Recursion’s Full Press Release
Recursion CEO Dr. Chris Gibson thanks CCM community members
In a video statement, Recursion Co-Founder and CEO Dr. Chris Gibson thanked the Alliance to Cure Cavernous Malformation, Connie Lee, and the CCM community for a decade-long partnership that enabled the first industry-sponsored Phase 2 trial evaluating a potential treatment for CCM.
“When Recursion was looking for patients to participate in this trial, so many of you raised your hand and were willing to volunteer. You gave of your valuable time and for that we are eternally thankful. We also appreciate your commitment to advancements in CCM science and treatment and look forward to continued partnership with all of you,” Gibson said.
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