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Recursion Announces Completion of Phase 1 Study for REC-3964 for Clostridioides Difficile Infection
REC-3964 has been well tolerated in healthy volunteers with no reported serious adverse events. Recursion to explore initiating a Phase 2 proof-of-concept
About this update from Recursion Pharmaceuticals, Inc.
[{"type":"text","content":"REC-3964 has been well tolerated in healthy volunteers with no reported serious adverse events. Recursion to explore initiating a Phase 2 proof-of-concept study in patients with recurrent Clostridioides difficile infection in 2024.\nSALT LAKE CITY, Sept. 05, 2023 (GLOBE NEWSWIRE) -- Recursion (NASDAQ: RXRX), a leading clinical stage TechBio company decoding biology to industrialize drug discovery, today announced it has completed the Phase 1 study for REC-3964 in healthy volunteers. The study achieved its primary objectives of assessing the safety, tolerability and pharmacokinetic profile of REC-3964. REC-3964 has been well tolerated with no serious adverse events (SAEs) reported. “This is an important step in our efforts to rapidly translate our first new chemical entity into a safe and effective therapy that has the potential to address a significant unmet need,” said David Mauro, M.D., Ph.D., Chief Medical Officer of Recursion. “We are encouraged by the strong safety and tolerability profile and are actively exploring the most expeditious path to advance this program to patients.” REC-3964 is a novel non-antibiotic small molecule inhibitor of C. difficile toxins that is being developed for the potential treatment of Clostridioides difficile (C. diff) infection, a bacterial disease that impacts more than 730,000 people in the US and EU5 every year. REC-3964 is Recursion’s first and most advanced new chemical entity, demonstrating the power of Recursion’s platform to rapidly identify, validate, optimize and translate novel insights into clinical candidates. REC-3964 represents a novel small molecule approach designed to selectively inhibit the toxin produced by Clostridioides difficile in the gastrointestinal tract. This molecule has the potential, when used as part of a treatment regimen, to prevent recurrent disease and/or other forms of C. diff infection, which is a leading cause of antibiotic-induced diarrhea sometimes leading to significant morbidity and mortality. More than 29,000 patients die in the US every year from C. diff infection. About the Trial The Phase 1 study was designed as a first-in-human protocol evaluating single and multiple doses of orally administered REC-3964 in healthy volunteers. The study assessed the safety, tolerability and pharmacokinetic (PK) profile of REC-3964 and consisted of two parts: sing...