The Food and Drug Administration (FDA) has granted Fast Track designation to REC-4881 for the treatment of familial adenomatous polyposis in patients who have previously undergone a colectomy or proctocolectomy.
Familial adenomatous polyposis is a rare tumor syndrome caused by autosomal dominant inactivating mutations in the tumor suppressor gene APC. The disease is characterized by precancerous colorectal polyps that have a high risk of malignant transformation.
REC-4881 is an orally bioavailable, non-ATP-competitive allosteric small molecule inhibitor of MEK1 and MEK2. It is designed to reduce polyp burden and progression to adenocarcinoma in familial adenomatous polyposis patients. Prior clinical studies have found the investigational treatment to be well tolerated with a favorable gut-localized pharmacokinetic profile.
The Company expects to begin a phase 2, double-blind, randomized, placebo-controlled basket trial in the third quarter of 2022. The FDA previously granted Orphan Drug designation to REC-4881 for this indication.
Recursion is granted Fast Track designation for REC-4881 for the potential treatment of familial adenomatous polyposis. News release. Recursion. Accessed April 11, 2022. https://www.prnewswire.com/news-releases/recursion-is-granted-fast-track-designation-for-rec-4881-for-the-potential-treatment-of-familial-adenomatous-polyposis-301521102.html