Recursion is Granted FDA Fast Track Designation for REC-2282 for the Potential Treatment of NF2-Mutated Meningiomas
Published On: 11/18/2021
Recursion, a clinical-stage biotechnology company decoding biology by integrating technological innovations across biology, chemistry, automation, machine learning and engineering, today announced that the U.S. Food and Drug Administration (FDA) has granted the company Fast Track designation for the investigation of REC-2282 for treatment of patients with NF2-mutated meningiomas, including neurofibromatosis type-2 disease-related meningiomas. REC-2282 is a potentially first-in-class, orally bioavailable, CNS-penetrant small molecule HDAC inhibitor being developed for the treatment of NF2-mutated meningiomas.
The FDA's Fast Track designation was established to expedite the review of investigational drugs to treat serious conditions and address unmet medical needs by enabling important drugs to get to patients earlier if approved. Fast Track designation can lead to more frequent interactions with the FDA, as well as Accelerated Approval and/or Priority Review eligibility if certain criteria are met.
"The Fast Track designation for REC-2282 is an important addition to our work to develop this medicine to treat patients with neurofibromatosis type-2 and patients with sporadic meningiomas driven by mutations in the NF2 gene, for which there is a significant unmet need," said Recursion Chief Medical Officer Ramona Doyle, M.D. "I am pleased that the team continues to advance this important medicine towards a Phase 2/3, randomized, multi-center study in patients with NF2-mutated meningiomas, for which we expect to begin enrollment early next year."