Recursion adds FAP and C. diff clinical trials

Clostridium difficile

Recursion Pharmaceuticals has initiated two additional clinical trials including its first in-house generated new chemical entity to enter the clinic. 

The phase 2 TUPELO clinical trial is evaluating REC-4881 for the potential treatment of familial adenomatous polyposis (FAP) in patients who have previously undergone a colectomy/proctocolectomy. 

REC-4881 is an orally bioavailable, non-ATP-competitive allosteric small molecule inhibitor of MEK1 and MEK2 being developed to reduce polyp burden and progression to adenocarcinoma in people living with FAP.

It has been granted Fast Track and Orphan Drug designations for the potential treatment of FAP by the U.S. Food and Drug Administration (FDA) as well as Orphan Drug designation by the European Commission. 

There are currently no FDA-approved therapies for the treatment of FAP, a rare tumor predisposition syndrome affecting approximately 50,000 people in the U.S., France, Germany, Italy, Spain and the U.K. Recursion Pharmaceuticals discovered REC-4881 as a potential candidate for treatment of FAP by leveraging its proprietary AI-powered drug discovery platform, the Recursion OS, against cellular models of loss of function of the APC gene. Mutations in the APC gene lead to FAP. 

Recursion Pharmaceuticals is accelerating drug discovery

The company said it believes its approach, in which machine learning is used to identify relationships between biological contexts and chemical entities, enables Recursion Pharmaceuticals to accelerate the drug discovery process and expand the scope of potential therapeutic candidates for numerous diseases.

“Despite progress with surgical management, the need for effective therapies for FAP remains high due to continued risk of tumors post-surgery,” said Niloy Jewel Samadder, Professor of Medicine at Mayo Clinic, Enterprise Co-Director, Office of Individualized/Precision Medicine, Mayo Clinic Comprehensive Cancer Center. 

“The initiation of the TUPELO trial is an important step toward potential treatment options to reduce or eliminate the burden of this devastating disease.”

The TUPELO Phase 2 trial is a multicenter, randomized, double-blind, placebo-controlled two-part clinical trial to evaluate efficacy, safety, and pharmacokinetics of REC-4881 in patients with FAP.

Phase 1 trial of REC-3964

Recursion also announced the initiation of its phase 1 clinical trial evaluating REC-3964 in healthy volunteers. REC-3964 is a novel non-antibiotic small molecule inhibitor of Clostridium difficile toxins, which is being developed for the potential treatment of C. difficile infection, a bacterial disease that impacts more than 730,000 people in the U.S. and EU every year. It is the first new chemical entity discovered by the Recursion OS to enter clinical trials.

Recursion Pharmaceuticals discovered REC-3964 using its proprietary AI-powered drug discovery platform, the Recursion OS, in which machine learning is used to identify relationships between biological contexts and chemical entities.

REC-3964 represents a novel small molecule approach designed to selectively inhibit the toxin produced by C. difficile in the GI 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, a leading cause of antibiotic-induced diarrhea sometimes leading to significant morbidity and mortality.

Shafique Virani, chief business officer and interim chief medical officer at Recursion Pharmaceuticals, said, “We are encouraged by the preclinical data from this program and look forward to advancing it rapidly through clinical studies.”

The phase 1 study is a first-in-human protocol evaluating single and multiple doses of REC-3964 in healthy volunteers. The study will assess the safety, tolerability and pharmacokinetic profile of REC-3964 and will provide the basis for establishing the therapeutic potential of this novel C. difficile antitoxin agent.

Chris Gibson, CEO and co-founder of Recursion Pharmaceuticals, said: “Our teams have worked tirelessly to advance our first new chemical entity into a first-in-human study and deliver on our goals, initiating four new clinical trials this year. These include initiating a phase 2 trial for cerebral cavernous malformation (CCM) in March, a phase 2/3 trial for neurofibromatosis type 2 (NF2)-mutated meningiomas in June, and now our phase 2 trial for FAP and phase 1 trial for C. diff.” 

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