Recursion announces first patient dosed in Phase 2 clinical study of REC-3964, a potential first-in-class, oral, non-antibiotic small molecule for recurrent Clostridioides difficile infection
RXRX 10.22.2024
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Recent News
- 01.13.2025 - 43nd Annual J.P. Morgan Healthcare Conference
- 01.07.2025 - Recursion Announces Two Key Investigational Oncology Drugs Advancing to Clinical Trials, Targeting High Unmet Needs in Hematologic Malignancies, Small-Cell Lung Cancer, & More
- 01.06.2025 - Recursion to Present at 43rd Annual JP Morgan Healthcare Conference
Recent Filings
- REC-3964 is Recursion’s first new chemical entity developed using the RecursionOS.
- REC-3964 represents a novel, non-antibiotic approach with a unique mechanism of action that binds and blocks catalytic activity of the toxin's innate glucosyltransferase in order to inhibit the toxin produced byC. diff.in the gastrointestinal tract.
- There are up to 175,000 cases of recurrentC. diff.each year and more than 29,000 patients die in the
U.S. fromC. diff.annually. Rates of recurrentC. diff.have increased significantly in recent years, representing a major public health challenge.
Increasing cases of recurrentC. diff.infections pose significant public health challenges. Antibiotics, the standard treatment forC. diff.infections, disturb the gut microbiome due to their non-selective nature. Despite initial success, antibiotics fail to prevent recurrence in 20-30% of primary cases. Further, the risk of subsequent recurrence rises to 40% after the first and 45-65% after two or more.
REC-3964 is the first novel small molecule developed through Recursion’s Operating System, and selectively inhibits the glucosyltransferase activity of toxin B produced byC. diffin the gastrointestinal tract, offering a unique mechanism of action. Unlike antibiotics, which disrupt the gut microbiome, REC-3964 precisely targets the bacterial toxin while sparing healthy tissue, potentially minimizing adverse events. It is being studied as part of a treatment regimen to prevent recurrentC. diffinfections, a leading cause of antibiotic-associated diarrhea that can lead to significant morbidity and mortality.
Presented at the6th Edition of
“There’s a significant unmet need for new treatment options for patients withC. diff.infection that are easier to use and more cost effective,” said
“Patients withC. diffface significant challenges, with 20-30% of initial infections recurring after standard treatment and a 40% chance of further recurrence, often leading to severe complications and a diminished quality of life,” said
The Phase 2 ALDER clinical trial is a multi-center randomized study to investigate the safety, tolerability, pharmacokinetics (PK) and efficacy of REC-3964 at doses of either 250 mg or 500 mg for the reduction ofC. diff.and will include an observation only arm. Approximately 80 individuals will ultimately be enrolled in the study across the
AboutClostridioides difficileinfectionClostridioides difficile(C. diff.) infection is a bacterial disease that impacts more than 730,000 people in the
About REC-3964REC-3964 is a potential first-in-class, orally bioavailable non-antibiotic small molecule that is being investigated for the potential treatment of recurrentClostridioides difficile(C. diff.) infection. This selective inhibitor is Recursion’s first new chemical entity to reach the clinic, and binds and blocks catalytic activity of the toxin's innate glucosyltransferase. In preclinical studies, REC-3964 was found to be superior to bezlotoxumab in a human disease relevantC. diff. hamster model, with significant difference in probability of survival versus bezlotoxumab alone at the end of treatment. REC-3964 was also well tolerated in Phase 1 healthy volunteer studies, demonstrating potential safety and tolerability with no serious adverse events (SAEs).
About the TrialOur Phase 2 ALDER clinical trial is a multi-center, open-label study to investigate the safety, tolerability, pharmacokinetics (PK) and efficacy of REC-3964 (doses of either 250 mg or 500 mg PO every 12 hours) for the reduction ofClostridioides Difficileinfection (C. diff.). Approximately 80 individuals will be enrolled in this open-label Phase 2 study, randomized 1:2:1 to receive oral doses of REC-3964, 250 mg, 500 mg or observation. The purpose of this study is to investigate the safety, tolerability, pharmacokinetics (PK) and efficacy of REC-3964 for the reduction of recurrentClostridioides difficileinfection (rCDI) after initial cure with vancomycin. Participants will receive treatment with REC-3964 for 28 days.
About RecursionRecursion (NASDAQ: RXRX) is a clinical stage TechBio company leading the space by decoding biology to radically improve lives. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously generate one of the world’s largest proprietary biological and chemical datasets. Recursion leverages sophisticated machine-learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale — up to millions of wet lab experiments weekly — and massive computational scale — owning and operating one of the most powerful supercomputers in the world, Recursion is uniting technology, biology and chemistry to advance the future of medicine.
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Forward-Looking Statements
This document contains information that includes or is based upon “forward-looking statements” within the meaning of the Securities Litigation Reform Act of 1995, including, without limitation, those regarding the potential efficacy of REC-3964; timing of the Phase 2 clinical trial of REC-3964; early and late stage discovery, preclinical, and clinical programs; licenses and collaborations; prospective products and their potential future indications and market opportunities; Recursion OS and other technologies; business and financial plans and performance; and all other statements that are not historical facts. Forward-looking statements may or may not include identifying words such as “plan,” “will,” “expect,” “anticipate,” “intend,” “believe,” “potential,” “continue,” and similar terms. These statements are subject to known or unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements, including but not limited to: challenges inherent in pharmaceutical research and development, including the timing and results of preclinical and clinical programs, where the risk of failure is high and failure can occur at any stage prior to or after regulatory approval due to lack of sufficient efficacy, safety considerations, or other factors; our ability to leverage and enhance our drug discovery platform; our ability to obtain financing for development activities and other corporate purposes; the success of our collaboration activities; our ability to obtain regulatory approval of, and ultimately commercialize, drug candidates; our ability to obtain, maintain, and enforce intellectual property protections; cyberattacks or other disruptions to our technology systems; our ability to attract, motivate, and retain key employees and manage our growth; inflation and other macroeconomic issues; and other risks and uncertainties such as those described under the heading “Risk Factors” in our filings with the
Source: Recursion Pharmaceuticals, Inc.