Ayala Pharmaceuticals Announces Successful End-of-Phase 2 Meeting with FDA Regarding AL102 for the Treatment of Desmoid Tumors

Company confirms FDA agreement on key elements of the Phase 3 segment of ongoing RINGSIDE study, including dosing regimen of 1.2mg once daily

Enrollment in Phase 3 continuing as planned

Excerpt from the Press Release:

REHOVOT, Israel & MONMOUTH JUNCTION, N.J., July 05, 2023 (GLOBE NEWSWIRE) — Ayala Pharmaceuticals, Inc. (OTCQX: ADXS), a clinical-stage oncology company, today announced that it has concluded an instructive and successful End-of-Phase-2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA). 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.

“We are grateful for the FDA’s continued support and guidance, and very pleased to have reached agreement with the Agency on these items,” said Ken Berlin, President and Chief Executive Officer of Ayala. “Supported by the clinical data generated from studies to date, we believe AL102 has the potential to be a best-in-class gamma secretase inhibitor and may offer a promising new treatment option to patients with unresectable, recurrent or progressive desmoid tumors. There are currently no approved therapies for these rare tumors. Current standards of care, which include off-label chemotherapy, radiation and tyrosine kinase inhibitors, are often poorly tolerated and offer inconsistent efficacy. We look forward to completing enrollment of the Phase 3 segment of this important study.”

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

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