Phase 3 RINGSIDE Study Enrollment Complete for AL102 in Desmoid Tumors

Ayala Pharmaceuticals, a clinical-stage oncology firm, has achieved a significant development in its Phase 3 RINGSIDE study. The study, which is focused on evaluating the efficacy of AL102 in treating desmoid tumors, has successfully completed patient enrollment with a total of 156 participants. This accomplishment is a major step forward in the advancement of AL102, a potential gamma secretase inhibitor that could offer a once-daily treatment option for desmoid tumor patients.

The RINGSIDE study is structured as a seamless global multi-center trial, allowing for a direct transition from Phase 2 to Phase 3 without a conclusion to the earlier segment. In Phase 2, the study assessed the efficacy, safety, and tolerability of three different doses of AL102 in 42 patients. The Phase 3 segment is a double-blind, placebo-controlled trial, which aims to measure the progression-free survival (PFS) of patients with progressive desmoid tumors, with secondary endpoints encompassing objective response rate (ORR), duration of response (DOR), and patient-reported quality of life (QOL).

Kenneth Berlin, CEO of Ayala Pharmaceuticals, expressed gratitude to all those involved in the RINGSIDE study, including patients, families, clinical investigators, operational partners, and the Ayala team. He emphasized the enthusiasm and support received from clinical trial investigators and support staff during the enrollment process. The completion of enrollment is a crucial step towards offering a new treatment option for desmoid tumors and is a testament to the potential of AL102 as a leading therapy in this field.

Ayala Pharmaceuticals is dedicated to developing and commercializing therapeutics for individuals with rare tumors and aggressive cancers. The company's lead candidates include AL102, which has received Fast Track Designation and Orphan Drug Designation from the U.S. FDA, and is currently in the pivotal Phase 3 study (RINGSIDE). Additionally, the company is developing aspacytarabine (BST-236) for the first-line treatment of unfit acute myeloid leukemia (AML) patients.

Ayala Pharmaceuticals continues to focus on its mission to provide innovative treatments for rare and aggressive forms of cancer, with the goal of improving the lives of those affected by these diseases.