Recursion is Granted EU Orphan Drug Designation for REC-4881 for the Potential Treatment of Familial Adenomatous Polyposis
Recursion (NASDAQ: RXRX) announced that the European Commission granted Orphan Drug Designation for REC-4881, aimed at treating familial adenomatous polyposis (FAP). REC-4881 is a small molecule MEK1 and MEK2 inhibitor, designed to reduce polyp burden in FAP patients. Currently, there are no approved therapies for FAP, which affects about 50,000 patients in the US and Europe. This designation follows similar approvals by the FDA, helping to advance REC-4881 towards a Phase 2 clinical trial by the end of Q3 2022.
- European Commission granted Orphan Drug Designation for REC-4881, enhancing its development prospects.
- REC-4881 is being developed for a rare condition (FAP) with no approved therapies, indicating potential market opportunity.
- Previous FDA designations (Orphan Drug and Fast Track) support the rapid advancement of REC-4881.
- None.
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.
Recursion discovered REC-4881 as a potential candidate for treatment of FAP by leveraging its proprietary AI-powered drug discovery platform, the Recursion OS.
"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."
Within 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.
Learn more about Recursion at https://www.recursion.com/.
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. 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.
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 in the gastrointestinal tract throughout their lives. 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. 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. While surgical management and surveillance have improved the prognosis for FAP patients, duodenal and desmoid tumors remain major causes of death following colectomy in patients with FAP.
Recursion is the clinical-stage biotechnology company industrializing drug discovery by decoding biology. Enabling its mission is the Recursion Operating System, a platform built across diverse technologies that continuously expands one of the world's largest proprietary biological and chemical datasets, the Recursion Data Universe. Recursion leverages sophisticated machine-learning algorithms to distill from its dataset the Recursion Map, a collection of hundreds of billions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale — up to millions of wet lab experiments weekly — and massive computational scale — owning and operating one of the most powerful supercomputers in the world, Recursion is uniting technology, biology and chemistry to advance the future of medicine.
The Company is headquartered in Salt Lake City, where it is a founding member of BioHive, the Utah life sciences industry collective. Recursion also has offices in Toronto, Montréal and the San Francisco Bay Area. Learn more at www.Recursion.com, or connect on Twitter and LinkedIn.
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FAQ
What is REC-4881 and its significance for RXRX?
What recent approval has RXRX received for REC-4881?
What is familial adenomatous polyposis (FAP)?
When does Recursion plan to initiate the Phase 2 clinical trial for REC-4881?
How does REC-4881 work in the treatment of FAP?
