Aelis Farma Announces Completion of Patient Randomization for Phase 2b Study with AEF0117 for the Treatment of Cannabis Addiction - Seite 2

To ensure a smooth transition of AEF0117 to the Phase 3 study after a positive Phase 2b, Aelis Farma initiated, in parallel with the Phase 2b, a series of toxicology studies required by the regulatory authorities. Announced last November, the favourable safety profile observed in this context validates the positive observations of the independent Data Safety Monitoring Board (DSMB) for the initial 115 patients in the Phase 2b study, confirming the good tolerance of AEF0117 in individuals with cannabis addiction. Thanks to the completion of these non-clinical developments ahead of schedule, AEF0117 will be ready to enter the Phase 3 clinical study for cannabis addiction at the end of a positive Phase 2b, subject to regulatory approval of the Phase 3 design.

Pier Vincenzo Piazza, CEO of Aelis Farma, concluded: “We are delighted to announce the completion of the recruitment phase of this study, which is the largest ever conducted for the treatment of cannabis addiction. This important milestone, once again, demonstrates Aelis Farma's ability to deliver and meet deadlines. We are determined to continue our roadmap with the goal of offering an effective treatment against cannabis addiction, a condition affecting an increasing number of people worldwide. In this regard, I would like to thank Professor Levin, the investigators, the Aelis team, and naturally, the participants to the study for their trust and dedication to the development of this promising new treatment.”

The Phase 2b study is an integral part of the clinical program for AEF0117, which received USD 7.8 million of total funding from the National Institutes of Health (NIH), with USD 4.5 million allocated in late 2021 for the current development phase. Previously, a Phase 2a study, conducted by Pr. Margaret Haney (Columbia University, NY) in volunteers with cannabis addiction, provided initial evidence of the efficacy of AEF0117 with a favourable safety profile.

Based on encouraging Phase 2a results, Aelis Farma entered into an exclusive option and license agreement in 2021 with Indivior PLC, a leading pharmaceutical group in addiction treatment, for the development and commercialization of AEF0117 as a treatment for disorders due to excessive cannabis use. As part of this agreement, Aelis Farma has received already USD 30 million (option payment). If Indivior exercises the license option at the end of the Phase 2b (H2 2024), Aelis Farma will receive a USD 100 million license fee and up to USD 340 million in additional payments contingent on the achievement of development, regulatory and commercial milestones as well as, royalties on net sales of AEF0117 ranging between 12% and 20%. Following the exercise of the option, all development, registration, and commercialization costs of AEF0117 will be borne by Indivior.