Aelis Farma Completes Patient Enrollment for Marijuana Addiction Study

Bordeaux – Biopharmaceutical company Aelis Farma announced the completion of patient recruitment for a Phase 2b clinical trial investigating AEF0117, a potential treatment for cannabis use disorder (CUD). The study successfully enrolled 333 patients at 11 clinical centers in the United States, marking an important step in the development of the first drug.

AEF0117 is part of a new class of drugs called CB1 receptor-specific signaling inhibitors (CB1-SSi), designed to selectively inhibit the pathological activity of CB1 receptors without affecting their normal physiological functions. The Phase 2b trial is a double-blind, placebo-controlled study designed to determine the drug’s effectiveness in reducing cannabis consumption in patients with CUD.

The primary objective of the trial is to evaluate whether AEF0117 can increase the proportion of participants who smoke marijuana once a week or less compared with placebo. Secondary endpoints include additional reductions in consumption and potential improvements in quality of life. Preliminary results from the trial are expected by the end of the second quarter of 2024.

The study’s principal investigator, Professor Frances Levin of Columbia University, thanked the participants and participating medical teams and emphasized the need for more treatment options for CUD.

In preparation for the potential Phase 3 study, Aelis Farma also conducted parallel toxicity studies that confirmed the favorable safety profile of AEF0117 observed by the Data Safety Monitoring Board. The first 115 patients were treated independently.

Aelis Farma CEO Pier Vincenzo Piazza announced the company’s commitment to continue its journey aimed at providing effective treatments for cannabis addiction.

The Phase 2b study of AEF0117 is part of a National Institutes of Health (NIH)-funded clinical program with a total contribution of $7.8 million, of which $4.5 million was allocated for the current phase. In addition, Aelis Farma has an exclusive option and license agreement with Indivior PLC to develop and commercialize AEF0117. The successful development of the drug may bring significant economic benefits to Aelis Farma.

This news is based on a press release from Aelis Farma.

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