Aelis Farma Announces the Last Patient, Last Visit in its Clinical Phase 2b Trial with AEF0117 for the Treatment of Cannabis Use Disorder - Seite 3

The Phase 2b study is part of the clinical program for AEF0117, which received $7.8 million of total funding from the National Institutes of Health (NIH), with $4.5 million allocated in late 2021 for the current developmental phase, aiming to ready the compound to enter phase 3. The remaining $3.3 million were previously dedicated to help financing phase 1 and a Phase 2a study with AEF0117. The phase 2a study, conducted by Pr. Margaret Haney (Columbia University, NY) in volunteers with cannabis addiction, provided initial evidence of the efficacy of AEF0117 and confirmed a favorable safety profile.

License Option with Indivior

Based on promising phase 2a results, Aelis Farma entered an exclusive option and license agreement in 2021 with Indivior UK Limited, a subsidiary of Indivior PLC, which is a leading pharmaceutical group in addiction treatment, for the development and commercialization of AEF0117 as a treatment for disorders due to excessive cannabis use. Per agreement, Aelis Farma has already received $30 million (license option fee). Within three months following the end of phase 2 meeting with the FDA, Indivior will be able to exercise its license option, triggering the payment of a $100 million license fee, up to an additional $340 million in milestone payments contingent upon the achievement of development, regulatory, and commercial milestones, as well as royalties on net sales of AEF0117 ranging from 12% to 20%. Following the exercise of the option, all development, registration, and commercialization activities for AEF0117 in CUD shall be conducted by Indivior and those costs will be borne by Indivior.

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About AELIS FARMA

Founded in Bordeaux in 2013, Aelis Farma is a biopharmaceutical company that is developing a new class of drugs, the Signaling-Specific inhibitors of the CB₁ receptor of the endocannabinoid system (CB₁-SSi). CB₁-SSi have been developed by Aelis Farma based on the discovery of a natural regulatory mechanism of CB₁ hyperactivity made by the team led by Dr. Pier Vincenzo Piazza, the Company’s CEO, when he was the director of the Neurocentre Magendie of INSERM in Bordeaux. By mimicking this natural mechanism, CB₁-SSi appear to selectively inhibit the disease-related activity of the CB₁ receptor without disrupting its normal physiological activity. CB₁-SSi have consequently the potential to provide new safe treatments for several brain diseases.