Aelis Farma announced that it has received a unanimous positive recommendation from the Data Safety Monitoring Board (DSMB) to continue, without modifying the protocol, the phase 2b clinical study with AEF0117 for the treatment of cannabis addiction. A DSMB is a committee of independent experts, specialized in clinical research, that reviews studies’ data with a particular emphasis on tolerability and safety. The DSMB that analyzed the data from the phase 2b study with AEF0117 met to assess the safety and tolerability data on the first 115 patients treated for at least 4 weeks with AEF0117.

Following the meeting, the committee observed no serious adverse events or significant events associated with the treatment and recommended that the study be continued without any modifications to the protocol. The phase 2b study with AEF0117, currently being undertaken in 11 clinical centers in the United States, aims to demonstrate the efficacy of AEF0117 in treating cannabis use disorder, the modern medical definition of cannabis addiction. This double-blind placebo-controlled study should include a total of around 330 patients who 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 this study is to evaluate whether AEF0117 reduces cannabis use, measured by the increase in the proportion of subjects who use cannabis =1 day a week compared to the placebo. The proportion of patients achieving other levels of reduction of their use and a potential improvement in their quality of life will also be investigated. Enrollment in the study is continuing at a sustained pace, enabling the first results to be anticipated in mid-2024, as expected.