Recursion Achieves Orphan Drug Designation for REC-4881 for Potential Treatment of Familial Adenomatous Polyposis
SALT LAKE CITY, September 29, 2021 / PRNewswire / – Recursion (NASDAQ: RXRX), a clinical-stage biotechnology company decoding biology by integrating technological innovations in biology, chemistry, automation, machine learning and engineering, today announced that the United States Food and Drug Administration (FDA) has granted the company’s orphan drug designation to REC-4881 for the potential treatment of familial adenomatous polyposis (FAP). REC-4881 is an orally bioavailable small molecule allosteric inhibitor non-competitive with ATP from MEK1 and MEK2 under development to reduce tumor size in patients with FAP.
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, waiver of user fees, and potentially seven years of market exclusivity if the drug is approved.
“The orphan drug designation for REC-4881 is an important addition to our work in developing this drug to treat patients with FAP, for whom there is a significant unmet need,” said Ramona doyle, MD Chief Medical Officer of Recursion. “I am delighted that the team continues to advance this drug into a Phase 2, randomized, double-blind, placebo-controlled study to assess safety, pharmacokinetics and efficacy in patients with FAP, for which we plan to start recruiting patients within the next three months. quarters. “
FAP is a rare tumor syndrome without approved therapies. In the USA, France, Germany, Italy, Spain and in the UK alone, the disease affects around 50,000 patients. FAP is caused by autosomal dominant inactivating mutations in the tumor suppressor gene APC. Patients with FAP develop polyps and adenomas in the gastrointestinal tract throughout their lives. These growths are at high risk for malignant transformation and can lead to invasive cancers of the colon, stomach, duodenum, and rectal tissues. The standard of care for patients with FAP is colectomy, and without surgery, patients with FAP will progress to colorectal cancer in adulthood. After colectomy, patients receive endoscopic monitoring every 6 to 12 months to monitor disease progression. While surgical management and monitoring have improved the prognosis of patients with PAF, duodenal and desmoid tumors remain a major cause of death in patients with PAF after colectomy.
Learn more about Recursion and see its pipeline on Recursion.com/pipeline.
Recursion is a clinical-stage biotechnology company decoding biology by integrating technological innovations in the fields of biology, chemistry, automation, machine learning and engineering. Our goal is to radically improve the lives of patients and industrialize drug discovery. At the heart of our mission is the Recursion operating system, which combines an advanced infrastructure layer to generate what we believe to be one of the largest and fastest growing proprietary biological and chemical datasets. in the world. We combine this with Recursion Map, a suite of custom software, algorithms, and machine learning tools that we use to explore fundamental biology without human coercion and navigate to new biological knowledge. Learn more at www.Recursion.com, or log on to Twitter and LinkedIn.
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