REC-994 / Recursion Pharma - LARVOL DELTA

SYCAMORE: The Symptomatic Cerebral Cavernous Malformation Trial of REC-994 (clinicaltrials.gov) - P2 | N=62 | Completed | Sponsor: Recursion Pharmaceuticals Inc. | Active, not recruiting ➔ Completed | Trial completion date: Dec 2025 ➔ Jun 2025 | Trial primary completion date: Dec 2025 ➔ Jun 2025

Trial completion • Trial completion date • Trial primary completion date

Recursion Reports First Quarter 2025 Financial Results and Provides Business Update (GlobeNewswire) - "As part of this prioritization, the Company will discontinue development and/or pursue partnering opportunities for the following clinical programs: REC-994 (CCM): Totality of data supports the discontinuation of study....New findings: Long-term extension results showed no promising trends in MRI or functional outcomes in the placebo-to-400mg crossover, and the 400mg-to-400mg arm did not continue prior trends and was indistinguishable from natural history."

Discontinued • CNS Disorders

Recursion Provides Business Updates and Reports Fourth Quarter and Fiscal Year 2024 Financial Results (GlobeNewswire) - "REC-994: A potential first-in-disease oral superoxide scavenger for symptomatic CCM, showing robust safety in chronic dosing in a Phase 2 study...Next steps in this program will be informed by regulatory discussions and long-term extension data expected in 2025."

P2 data • CNS Disorders • Genetic Disorders

The SYCAMORE Study Results: First Randomized, Placebo-Controlled Phase 2 Trial in Symptomatic Cerebral Cavernous Malformation (CCM) Evaluating REC-994 (ISC 2025) - "Overall, REC-994 has the potential to help CCM patients who have no pharmacologic treatment and few medical options. This is especially important to those with greatest unmet need such as patients with multiple lesions due to genetic abnormalities (chronic disease) and where CCM lesions are located in inaccessible locations too risky for resection."

Clinical • Late-breaking abstract • P2 data • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Epilepsy • Hematological Disorders • Pain • Rare Diseases

Clinical pharmacology and tolerability of REC-994, a redox-cycling nitroxide compound, in randomized phase 1 dose-finding studies. (PubMed, Pharmacol Res Perspect) - "REC-994 has a favorable safety profile and was well tolerated in single and multiple doses up to 800 mg with no dose-limiting adverse effects identified. Data support conducting a phase 2 clinical trial in patients with symptomatic CCM."

Clinical • Journal • P1 data • P1 data • Cardiovascular • Cerebral Hemorrhage • Genetic Disorders • Hematological Disorders