Ayala Pharmaceuticals, Inc. has successfully concluded an End-of-Phase 2 meeting with the FDA regarding AL102, a potential treatment for desmoid tumors. The company confirms agreement with the FDA on key elements of the Phase 3 segment of the ongoing RINGSIDE study, including the dosing regimen. Enrollment in Phase 3 is continuing as planned.
Desmoid tumors are rare connective tissue tumors that currently have no approved treatments. Ayala Pharmaceuticals believes that AL102 has the potential to be a best-in-class gamma secretase inhibitor and offer a promising new treatment option for patients with these tumors.
The Phase 3 segment of the RINGSIDE study is a double-blind, multi-center trial enrolling up to 156 patients with progressive disease. They will be randomized between receiving AL102 or placebo, and the primary endpoint is progression-free survival.
AL102 received Fast Track designation from the FDA for the treatment of desmoid tumors. The RINGSIDE study is a pivotal Phase 2/3 study evaluating AL102's efficacy and safety in patients with desmoid