Aelis Farma has received a positive opinion from the Data Safety Monitoring Board (DSMB) to continue its Phase 2b clinical study with AEF0117 in cannabis addiction, without any change to the protocol.

A DSMB is a committee of independent experts, specialized in clinical research, which reviews study data with particular attention to safety and tolerability.

The DSMB which analyzed the data from the AEF0117 Phase 2b study met to evaluate the safety and tolerability data on the first 115 patients who had been treated for at least 4 weeks with AEF0117.

Following this meeting, the committee noted no serious adverse events or significant treatment-related events, and recommended continuation of the study without protocol modification.

Phase 2b of AEF0117, conducted at 11 clinical centers in the U.S., aims to demonstrate the efficacy of AEF0117 in the treatment of cannabis use disorders, the modern medical definition of cannabis addiction.

Pier Vincenzo Piazza, Chief Executive Officer of Aelis Farma, commented: ' The fact that it is safe and well tolerated in patients under real-life conditions is crucial and very favorable for the further development of AEF0117, the only molecule that to date represents real hope for many people suffering from the pathologies engendered by excessive cannabis use. '

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