Aelis Farma S.A. announces the enrollment of the 1st patient in the phase 2b study of AEF0117 for the treatment of cannabis use disorder, the current medical definition of cannabis addiction. AEF0117 is the first drug candidate of a proprietary new class of drugs developed by Aelis Farma, the Signaling Specific inhibitors of the CB1 receptor, the "CB1-SSi". The CB1 is the principal receptor of the endocannabinoid system and one of the most expressed neurotransmitter receptors of the brain.

This receptor is involved in the regulation of several brain functions, and it is also the main target of the active ingredient of cannabis, THC. CB1-SSi, by mimicking a recently discovered natural defense mechanism of the brain1 has the potential to treat various brain pathologies without disrupting normal brain functions and behavior. The phase 2b clinical trial aims to demonstrate the efficacy of AEF0117 for the treatment of cannabis use disorder.

The study is expected to include approximately 330 patients at 9 participating clinical centers in the United States. This double-blind, placebo-controlled study will include four separate patient arms, which will be administered either a placebo or one of the three test doses of AEF0117 (0.1 mg, 0.3 mg and 1 mg) once daily for 3 months. The primary objective of the study is to demonstrate if AEF0117 reduces cannabis use, as measured by the increase in the proportion of subjects with a response of =1 day of cannabis use per week compared to placebo.

The proportion of patients reaching other levels of reduction of use and the potential improvement of their quality of life will also be investigated. The results of the study are expected in 2024. This phase 2b study is part of the clinical development program of AEF0117 that has received a total of $7.8 million in grants from the National Institutes of Health (NIH) of which $4.5 million was allocated at the end of 2021 for this new phase of development.

A previous phase 2a study in subjects with cannabis use disorder, performed at Columbia University (NY) by Dr. Margaret Haney, provided preliminary evidence of the efficacy of AEF0117 with a good safety profile. Based on encouraging phase 2a results, in June 2021, Aelis Farma entered in an exclusive option and license agreement with Indivior PLC, an international leader in addiction medicine, for the development and commercialization of AEF0117 as a treatment for disorders linked to excessive cannabis use. As part of this collaboration, Aelis Farma received $30 million (option payment).

If Indivior exercises the license option at the end of the phase 2b study, Indivior will pay Aelis Farma $100 million to acquire the license (potentially in 2024) and up to an additional $340 million if development, regulatory and commercial milestones are achieved, as well as royalties on net sales of AEF0117 of between 12% and 20%. Following the exercise of the option, all development, registration, and commercialization costs of AEF0117 will be borne by Indivior.