Investigational, Non-Antibiotic Begins Phase 2 Trial for Recurrent C difficile

Recursion, a company based in Salt Lake City, Utah, announced it has begun its phase 2 ALDER clinical trial to investigate the safety, tolerability, pharmacokinetics and efficacy of their investigational non-antibiotic therapy, REC-3964, for the treatment of recurrent C difficile. This is a multi-center randomized study that will examine doses of either 250 mg or 500 mg for the reduction of C diff, and will include an observation only arm. Approximately 80 individuals will ultimately be enrolled in the study across the US and Europe. The study will randomize using 1:2:1 to receive oral doses of REC-3964, 250 mg, 500 mg or observation. This study is looking to include participants initially cured with vancomycin. Participants will receive treatment with REC-3964 for 28 days.

There’s a significant unmet need for new treatment options for patients with C diff infection that are easier to use and more cost effective,” said Recursion CEO Chris Gibson, PhD, said in a statement. “We are encouraged by the progress of REC-3964, the first new chemical entity from our platform to advance to phase 2 clinical trials, and now, to the first patient dosed. We look forward to continuing to advance this trial to help patients in need and drive down billions in costs to the healthcare system for treatment.”

REC-3964 is a novel small molecule developed by the company’s operating system (OS) that selectively inhibits the glucosyltransferase activity of toxin B produced by C diff in 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.

The company says its Recursion OS is a platform built across diverse technologies that continuously generate one of the world’s largest proprietary biological and chemical datasets. Recursion leverages machine-learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. The company is able to scale up to millions of wet lab experiments weekly.

According to the company, preclinical studies demonstrated its superiority over bezlotoxumab in an animal model. Additionally, phase 1 studies in healthy volunteers showed REC-3964 was well tolerated with no serious adverse events (SAEs), underscoring its potential safety and tolerability.

“For these patients and their families, the need for safe, effective, non-antibiotic treatment options is critical. REC-3964 offers a novel, targeted approach by selectively inhibiting the bacterial toxin while sparing the host,” Recursion Chief Commercial Officer and Chief R&D Officer Najat Khan, PhD, said in a statement. “With encouraging preclinical data and strong tolerability demonstrated in phase 1 studies, it’s particularly rewarding to see the first drug developed using the Recursion OS and advancing to phase 2 trials.”

Reference

1. 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. Recursion press release. October 22, 2024. Assessed October 28, 2024. https://ir.recursion.com/news-releases/news-release-details/recursion-announces-first-patient-dosed-phase-2-clinical-study