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Recursion is Granted Orphan Drug Designation for REC-4881 for the Potential Treatment of Familial Adenomatous Polyposis

October 5, 2021

Recursion, a clinical-stage biotechnology company decoding biology by integrating technological innovations across biology, chemistry, automation, machine learning and engineering, today announced that the U.S. Food and Drug Administration (FDA) has granted the company orphan drug designation for REC-4881 for the potential treatment of familial adenomatous polyposis (FAP). REC-4881 is an orally bioavailable, non-ATP-competitive allosteric small molecule inhibitor of MEK1 and MEK2 being developed to reduce tumor size in FAP patients.

The FDA designates orphan products to support the development and evaluation of new treatments for rare diseases. The designation qualifies the sponsor for incentives including tax credits for qualified clinical trials, exemption from user fees and potentially seven years of market exclusivity if the medicine is approved.

“The orphan drug designation for REC-4881 is an important addition to our work to develop this medicine to treat patients with FAP, for which there is significant unmet need,” said Ramona Doyle, M.D. chief medical officer of Recursion. “I am pleased that the team continues to advance this medicine towards a Phase 2, randomized, double-blind, placebo-controlled study to evaluate safety, pharmacokinetics and efficacy in FAP patients, for which we expect to begin enrolling patients within the next three quarters.”

FAP is a rare tumor syndrome with no approved therapies. In the US, France, Germany, Italy, Spain and the UK alone the disease affects approximately 50,000 patients. FAP is caused by autosomal dominant inactivating mutations in the tumor suppressor gene APC. FAP patients develop polyps and adenomas in the gastrointestinal tract throughout life. These growths have a high risk of malignant transformation and can give rise to invasive cancers of the colon, stomach, duodenum and rectal tissues. Standard of care for patients with FAP is colectomy, and without surgical intervention, affected patients will progress to colorectal cancer in adulthood. Post-colectomy, patients receive endoscopic surveillance every 6-12 months to monitor disease progression. While surgical management and surveillance have improved the prognosis for FAP patients, duodenal and desmoid tumors remain a major cause of death in patients with FAP following colectomy.

Learn more about Recursion and view its pipeline at Recursion.com/pipeline.