Ayala Pharmaceuticals Announces Completion of Enrollment in Phase 3 RINGSIDE Study Evaluating AL102 in Desmoid Tumors

2024-02-21

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Feb. 20, 2024-- Ayala Pharmaceuticals, Inc. (OTCQX: ADXS), a clinical-stage oncology company, today 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. ”Completion of enrollment in RINGSIDE represents a significant milestone in the development of AL102,” said Kenneth Berlin, President and Chief Executive Officer of Ayala. “There has been a high-level of enthusiasm from clinical trial investigators, support staff, and patients during the enrollment of RINGSIDE. We are extremely grateful to the patients and their families, clinical investigators, operational partners and the Ayala team who have helped us achieve this important milestone several months ahead of schedule. Completing enrollment is an important step toward our goal of providing patients and physicians with a once-daily treatment option for desmoid tumors. We believe that AL102 has the potential to be a best-in-class gamma secretase inhibitor for this disease.”

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.

About RINGSIDE

The RINGSIDE pivotal Phase 2/3 study is a randomized global multi-center trial, with a seamless design, which allowed Ayala to continue to Phase 3 without concluding the Phase 2 segment. The Phase 2 segment of the study (Part A) evaluated the efficacy, safety, tolerability, and tumor volume by MRI after 16 weeks of AL102 in patients with desmoid tumors. It enrolled 42 patients and evaluated 3 doses of AL102. Phase 3 of RINGSIDE (Part B) is a double-blind, placebo-controlled, clinical trial enrolled a total of 156 patients with progressive disease, comparing AL102 at 1.2 mg once-daily to placebo. For more information on the RINGSIDE Phase 2/3 study of AL102 for the treatment of desmoid tumors, please visit ClinicalTrials.gov and reference Identifier NCT04871282 (RINGSIDE).

About Ayala Pharmaceuticals, Inc.

Ayala Pharmaceuticals, Inc. is a clinical-stage oncology company primarily focused on developing and commercializing small molecule therapeutics for people living with rare tumors and aggressive cancers. The Company’s lead candidates under development are the oral gamma secretase inhibitor, AL102, for desmoid tumors, and aspacytarabine (BST-236), a novel proprietary anti-metabolite for first line treatment in unfit acute myeloid leukemia (AML). AL102 has received Fast Track Designation and Orphan Drug Designation from the U.S. FDA, and is currently in the Phase 3 segment of a pivotal study for patients with desmoid tumors (RINGSIDE). On February 6 2024, Ayala announced that it had entered into a definitive agreement with Immunome (Nasdaq:IMNM) whereby Immunome will acquire certain assets and liabilities relating to AL102 and related drug candidate AL101, constituting substantially all of Ayala’s assets.

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机构

Ayala Pharmaceuticals, Inc.