Nature Medicine Publishes Discovery of New Pharmacological Class by Aelis Farma, Phase 2a Study of First Drug Candidate for Cannabis Use Disorder

Regulatory News:

Aelis Farma (ISIN: FR0014007ZB4 – Ticker: AELIS), a clinical-stage biopharmaceutical company focused on developing treatments for brain diseases, today announced publication of a series of studies describing a new pharmacological class, cannabinoid receptor 1 signaling-specific inhibitors (CB₁-SSi), and its first drug candidate, AEF0117, for the treatment of cannabis use disorder (CUD).

The report, “Signaling-specific inhibition of the CB₁ receptor for cannabis use disorder: phase 1 and phase 2a randomized trials,” was published online by the journal Nature Medicine.

AEF0117 is the first compound that selectively inhibits the CB₁ receptor signaling pathway responsible for the addictive effects of cannabis, without interfering with the receptor's fundamental physiological and behavioral functions. This breakthrough approach differs from previous CB₁ receptor antagonists that, due to their broad blockade of all CB₁ receptor activity, caused significant adverse effects preventing their clinical use.

AEF0117, discovered and developed by Aelis Farma, is the first of the new pharmacologic class, CB₁-SSi, which is based on a natural brain mechanism that combats CB₁ receptor hyperactivity. This mechanism was discovered by the research group of Aelis Farma Chief Executive Officer Pier Vincenzo Piazza, MD, PhD, when he was the director of the Neurocentre Magendie of the French National Institute of Health and Medical Research (INSERM) in Bordeaux.¹ This unique mechanism of action enables CB₁-SSi to inhibit only the cellular signals involved in CUD – without disrupting the receptor’s physiological activity. The CB₁-SSi class and AEF0117 represent a breakthrough in CB₁ pharmacology.

“This landmark article culminates more than a decade of research, from discovery of this natural brain mechanism to our proof-of-concept clinical trial,” said Dr. Piazza. “We are delighted to contribute to the field of neuropharmacology with a class of drugs never tested in humans before. Now, we at Aelis are sponsoring a large, placebo-controlled phase 2b study in collaboration with Columbia University Irving Medical Center, enrolling 330 participants with CUD to evaluate three dose levels of AEF0117 in treating cannabis addiction. Results should be available by mid-2024.”