Ayala announces End-of-Phase 2 meeting with FDA on AL102 in desmoid tumors

Ayala Pharmaceuticals has concluded an instructive and successful End-of-Phase-2 meeting with the U.S. Food and Drug Administration. As a result of the meeting, the company confirms that it is in agreement with the FDA on key elements of the randomized Phase 3 segment of RINGSIDE. The Agency accepted the Company’s selection of the 1.2 mg once daily dose being evaluated in the currently-enrolling Phase 3 and the completed and proposed clinical pharmacology plan. As previously agreed with the FDA on a seamless Phase 2/3 design, enrollment in the Phase 3 segment of RINGSIDE commenced in November 2022, and is continuing globally as planned, with target enrollment of 156 patients. The Phase 3 segment of the RINGSIDE study is a double-blind, multi-center trial enrolling up to 156 patients with progressive disease, randomized between AL102 1.2mg dosed once daily or placebo. The primary endpoint is progression-free survival with secondary endpoints including objective response rate, duration of response, and patient-reported Quality of Life measures. AL102 received Fast Track designation from the U.S. FDA for the treatment of progressing desmoid tumors, a rare disease with no currently approved treatments.