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Ayala Pharmaceuticals Reports Favorable Results from End-of-Phase 2 Meeting with FDA Regarding AL102 for Desmoid Tumor Treatment

Thursday, July 06, 2023

Ayala Pharmaceuticals, Inc. (OTCQX: ADXS) recently announced the successful conclusion of an End-of-Phase-2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA). During the meeting, Ayala reached an agreement with the FDA on key elements of the randomized Phase 3 segment of the RINGSIDE study. The FDA accepted Ayala's selection of the 1.2 mg once-daily dose and the proposed clinical pharmacology plan for the ongoing Phase 3 trial.

The Phase 3 segment of the RINGSIDE study is a double-blind, multi-center trial aiming to enroll up to 156 patients with progressive desmoid tumors. Patients will be randomized to receive either AL102 1.2mg once daily or a placebo. The primary endpoint of the study 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.

Desmoid tumors, also known as aggressive fibromatosis or desmoid-type fibromatosis, are rare connective tissue tumors that can infiltrate nearby structures and organs. They do not metastasize but can cause significant pain, functional deficits, and a decrease in the quality of life for affected individuals. Currently, there are no FDA-approved systemic therapies for unresectable, recurrent, or progressive desmoid tumors.

AL102, an investigational small molecule gamma secretase inhibitor (GSI), has received Fast Track designation from the FDA for the treatment of progressing desmoid tumors. AL102 is designed to selectively inhibit Notch 1, 2, 3, and 4, and it holds potential as a best-in-class gamma secretase inhibitor. Ayala obtained an exclusive, worldwide license to develop and commercialize AL102 from Bristol-Myers Squibb Company in November 2017.

The RINGSIDE study is a pivotal Phase 2/3 trial that has a seamless design, allowing Ayala to progress from Phase 2 to Phase 3 without concluding the Phase 2 segment. The Phase 2 segment of the study evaluated the efficacy, safety, tolerability, and tumor volume in patients with desmoid tumors who received AL102. The Phase 3 segment, currently underway, will provide further evidence of AL102's effectiveness in treating desmoid tumors.

Ayala's agreement with the FDA on the Phase 3 segment of the RINGSIDE study marks a significant milestone in the development of AL102 as a potential treatment option for patients with desmoid tumors. The company is grateful for the FDA's support and guidance and is committed to completing the enrollment of the Phase 3 segment of the study.

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