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BORDEAUX – Aelis Farma, a biopharmaceutical company, has announced the completion of patient recruitment for its Phase 2b clinical trial, which is investigating AEF0117, a potential treatment for cannabis use disorder (CUD). The study successfully enrolled 333 patients across 11 U.S. clinical centers, marking a significant step in the development of this first-in-class drug.

AEF0117 is part of a new class of drugs known as Signaling Specific inhibitors of the CB1 receptor (CB1-SSi) and is designed to selectively inhibit the pathological activity of the CB1 receptor without affecting its normal physiological function. The Phase 2b trial is a double-blind, placebo-controlled study that aims to determine the drug’s efficacy in reducing cannabis consumption in individuals diagnosed with CUD.

The primary goal of the trial is to assess whether AEF0117 can increase the proportion of participants who consume cannabis one day per week or less compared to a placebo. Secondary endpoints include other levels of reduced consumption and potential improvements in quality of life. Initial results from the trial are expected by the end of the second quarter of 2024.

Professor Frances Levin from Columbia University, the principal investigator of the study, expressed gratitude toward the participants and medical teams involved and highlighted the demand for treatment options for CUD.

In preparation for a potential Phase 3 study, Aelis Farma has also conducted parallel toxicology studies, which have reportedly confirmed AEF0117’s favorable safety profile as observed by the independent Data Safety Monitoring Board for the initial 115 patients.

The CEO of Aelis Farma, Pier Vincenzo Piazza, stated the company’s commitment to continuing its roadmap with the aim of providing an effective treatment for cannabis addiction.

The Phase 2b study of AEF0117 is part of a clinical program funded by the National Institutes of Health (NIH), which contributed USD 7.8 million in total, with USD 4.5 million allocated for the current phase. Additionally, Aelis Farma has an exclusive option and license agreement with Indivior PLC for the development and commercialization of AEF0117, which could lead to significant financial benefits for Aelis Farma upon successful advancement of the drug.

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

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