European Commission grants orphan drug designation to Recursion’s REC-4881

At present, the standard of care for patients with FAP is colectomy, and without surgical intervention, affected patients will progress to colorectal cancer in adulthood.

European Commission grants orphan drug designation to Recursion’s REC-4881
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Recursion, the clinical-stage biotechnology company, announced on Friday that the European Commission has granted Recursion Orphan Drug Designation for REC-4881 for the potential treatment of familial adenomatous polyposis (FAP).

According to reports, 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 FAP patients. Reportedly, Recursion discovered REC-4881 as a potential candidate for the treatment of FAP by leveraging its proprietary AI-powered drug discovery platform, the Recursion OS.

“FAP is a rare tumour syndrome that affects approximately 50,000 patients in the US, France, Germany, Italy, Spain and the UK, with no approved therapies. Recursion is excited about this Orphan Drug Designation in the European Union as we continue to advance towards initiating a phase 2 clinical trial”, said Meredith Brown-Tuttle, vice president of regulatory affairs.

Within the past 10 months, the US Food and Drug Administration (FDA) granted the company Orphan Drug and Fast Track designations for REC-4881 to support the development and evaluation of new treatments for FAP.

FAP is a rare tumour syndrome with no approved therapies yet. In countries like 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 tumour suppressor gene APC. According to experts, these growths have a high risk of malignant transformation and can give rise to invasive cancers of the colon, stomach, duodenum, rectum, and other tissues.

At present, the standard of care for patients with FAP is colectomy, and without surgical intervention, affected patients will progress to colorectal cancer in adulthood. Even after colectomy, patients receive endoscopic surveillance every 6-12 months to monitor disease progression.

Although surgical procedures and monitoring have improved the prognosis for FAP patients, duodenal and desmoid tumours remain major causes of death following colectomy in patients with FAP.

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