Ayala Pharmaceuticals AL102 gets FDA fast track status in desmoid tumors
Ayala Pharmaceuticals has been granted fast track designation for its oral gamma-secretase inhibitor AL102 by the US Food and Drug Administration (FDA) for the treatment of progressing desmoid tumors.
AL102 is currently being assessed by the clinical-stage oncology company in the phase 2/3 RINGSIDE clinical trial in desmoid tumors.
According to Ayala Pharmaceuticals, in Part A, that is phase 2 segment of the study, AL102 showed efficacy in all cohorts, with early tumor responses that extended over time.
AL102 was well tolerated in Part A of the RINGSIDE clinical trial.
Ayala Pharmaceuticals has started Part B of the RINGSIDE trial, which is phase 3, and is taking in patients in an open label extension study.
Roni Mamluk — Ayala Pharmaceuticals CEO said: “We are pleased to receive FDA Fast Track designation for AL102 in progressing desmoid tumors, which we believe reinforces the large unmet medical need for patients with this serious disease. This designation holds important advantages that may expedite the development and regulatory review of AL102.
“We are very encouraged by the emerging body of clinical data supporting AL102 and, if approved, believe that this product could have a meaningful impact on patients’ lives.”