NEW YORK – Recursion announced on Monday the launch of a Phase II/III trial evaluating its histone deacetylase (HDAC) inhibitor REC-2282 for NF2-mutated meningiomas.
The POPLAR-NF2 clinical trial, which Salt Lake City-based Recursion announced during the Children's Tumor Foundation NF Conference, is designed to evaluate REC-2282 in roughly 90 patients over age 12 who have sporadic meningioma with confirmed neurofibromatosis type 2 (NF2) mutations; confirmed diagnoses of NF2 disease; or at least one NF2-related tumor, meaning a tumor with a pathogenic germline or proven mosaic NF2 variant.
The randomized trial pits REC-2282 against placebo, and its primary aim is to evaluate whether REC-2282 can improve patients' progression-free survival versus the control arm.
Recursion developed the REC-2282 using a machine learning approach, dubbed Recursion OS. The US Food and Drug Administration has given REC-2282 orphan drug and fast-track status. The European Commission has also granted the drug orphan designation for NF2-mutated meningiomas.
According to the firm, if REC-2282 successfully reaches the market, it could be the first approved treatment for NF2-mutated meningiomas, which affect around 33,000 patients in the US every year.