Ayala Pharmaceuticals Announces First Patient Dosed with AL102 in Phase 3 Segment of RINGSIDE ...

REHOVOT, Israel and WILMINGTON, Del., Nov. 16, 2022 (GLOBE NEWSWIRE) -- Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare tumors and aggressive cancers, today announced that the first patient has been dosed in Part B of RINGSIDE, the Phase 3 randomized segment of the trial evaluating AL102 in desmoid tumors. AL102 is a potent, selective, oral gamma-secretase inhibitor (GSI).

“We are pleased to begin enrollment in the Phase 3 segment of RINGSIDE, which is a significant milestone in our AL102 development program,” said Roni Mamluk, Ph.D., President and Chief Executive Officer of Ayala. “The emerging data from Phase 2 / Part A have been very promising and we have selected a dose of 1.2mg once-daily for the randomized portion. If approved, AL102 has the potential to improve the lives of people living with desmoid tumors.”

The Phase 3 segment of RINGSIDE 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 (PFS) with secondary endpoints including objective response rate (ORR), duration of response (DOR), and patient-reported Quality of Life (QOL) measures.

Positive interim data from Part A, the Phase 2 segment of RINGSIDE were presented at ESMO in September 2022. Data showed efficacy across all cohorts, with early responses that deepened over time. The first confirmed partial response (PR) was achieved at week 16 and 3 additional unconfirmed PRs over the follow-up period. AL102 was well tolerated with no dose-limiting toxicities and no Grade 4/5 adverse events. Longer-term data from Phase 2 / Part A of RINGSIDE are expected in mid-2023.