What do we know about the development of the AEF0117 molecule?
Aelis Farma, a biopharmaceutical company specializing in the development of treatments for brain diseases, announced the completion of phase "2b" of the clinical study on the molecule AEF0117, intended to treat cannabis addiction, or CUD (Cannabis Use Disorder).
This pivotal stage involved 333 patients and concluded with the last medical visit of the last participant in April 2024.
The AEF0117 molecule represents the first class of drugs that inhibit CB1 receptor signaling (CB1-SSi), which is found in the endocannabinoid system, disseminated throughout the body, particularly in the brain.
This compound has demonstrated a favorable safety profile, particularly in long-term toxicology studies in rats and dogs. It could be used for long-term treatments without causing heavy side effects. Studies also indicate possible administration in adolescents who are most affected by CUD in France.
With the completion of the toxicity studies and the non-clinical development phases, the AEF0117 molecule is ready to begin phase 3 clinical studies, pending positive results from the phase “2b” and approval from the National Agency for the Safety of Medicines and Health Products (ANSM) to move forward.
AEF0117: the subject of a partnership between Aelis Farma and Indivior
Following the promising results of phase “2a”, Aelis Farma signed an exclusive option and license agreement in 2021 with Indivior UK Limited, a subsidiary of the leading pharmaceutical group Indivior PLC, specializing in the treatment of addictions.
This agreement concerns the development and marketing of the AEF0117 molecule to treat disorders linked to excessive and sustained cannabis consumption. Aelis Farma also received a first payment of $30 million for the option.
If Indivior decides to exercise its licensing option following the completion of Phase 2 with the FDA, it will trigger a licensing fee payment of $100 million, followed by payments of up to $340 million dollars depending on the achievement of certain development, regulatory and commercial milestones.
In addition, Aelis Farma will receive royalties on net sales of its AEF0117 molecule, ranging between 12% and 20%. After the exercise of the option, Indivior will be responsible for all remaining stages of the development, registration and commercialization of the molecule. It would thus cover all costs associated with this project.
