AYALA PHARMACEUTICALS, INC. Ayala Pharmaceuticals, Inc. announced that patient enrollment has been completed in the Phase 3 RINGSIDE study evaluating AL102 in desmoid tumors. A total of 156 patients were enrolled. The Phase 3 segment of the RINGSIDE study is a double-blind, multi-center trial enrolling patients with progressive disease, randomized between AL102 1.2 mg dosed once daily or placebo.
The primary endpoint is progression-free survival (PFS) with secondary endpoints including objective response rate (ORR), duration of response (DOR), and patient-reported Quality of Life (QOL) measures. RINGSIDE has been designed as a registration study to support a New Drug Application (NDA) in desmoid tumors.
