Business
Recursion is Granted EU Orphan Drug Designation for REC-4881 for the Potential Treatment of Familial Adenomatous Polyposis
SALT LAKE CITY, July 21, 2022 /PRNewswire/ -- Recursion (NASDAQ: RXRX), the clinical-stage biotechnology company industrializing drug discovery by decoding
About this update from Recursion Pharmaceuticals, Inc.
[{"type":"text","content":"SALT LAKE CITY, July 21, 2022 /PRNewswire/ -- Recursion (NASDAQ: RXRX), the clinical-stage biotechnology company industrializing drug discovery by decoding biology, today announced that the European Commission has granted Recursion 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 polyp burden and progression to adenocarcinoma in FAP patients. \n\n \n \n \n \n \n \n\n \nRecursion discovered REC-4881 as a potential candidate for treatment of FAP by leveraging its proprietary AI-powered drug discovery platform, the Recursion OS.\n\"FAP is a rare tumor syndrome that affects approximately 50,000 patients in the US, France, Germany, Italy, Spain and the UK, with no approved therapies\", said Meredith Brown-Tuttle, Vice President of Regulatory Affairs. \"Recursion is excited about this Orphan Drug Designation in the European Union as we continue to advance towards initiating a Phase 2 clinical trial.\"\nWithin the past 10 months, the U.S. 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.\nLearn more about Recursion at https://www.recursion.com/.\nAbout REC-4881REC-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. REC-4881 has been well tolerated in prior clinical studies, consistent with the intended use, and has a gut-localized PK profile that may be advantageous for FAP, and potentially other APC-driven gastrointestinal tumors. We expect to initiate a Phase 2, double-blind, randomized, placebo-controlled clinical trial of REC-4881 in FAP by the end of this quarter.\nAbout Familial Adenomatous PolyposisFAP 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 in the gastrointestinal tract throughout their lives. These growths have a high risk of malignant...