(CercleFinance.com) – Aelis Farma has received the positive opinion of the Data Safety Monitoring Board (DSMB) for the continuation without change to the protocol of its phase 2b clinical study with AEF0117 in cannabis addiction.
A DSMB is a committee of independent experts, specialized in clinical research, which reviews data from studies with particular attention to tolerance and safety.
The DSMB, which analyzed the data from the phase 2b study of AEF0117, met to assess the safety and tolerance 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 events related to the treatment and recommended the continuation of the study without modification of the protocol.
Phase 2b of AEF0117, conducted at 11 clinical centers in the United States, aims to demonstrate the efficacy of AEF0117 in the treatment of cannabis use disorder, the modern medical definition of cannabis addiction.
Pier Vincenzo Piazza, CEO of Aelis Farma, said: ‘The fact that it is safe and well tolerated in patients in real life conditions is crucial and very favorable for the further development of AEF0117, the only molecule that represents to this day a real hope for many people suffering from the pathologies caused by the excessive use of cannabis. ‘