Aelis Farma, a clinical-stage biopharmaceutical company specializing in the development of treatments for brain diseases, announced that it has received a positive and unanimous recommendation from the Data Safety Monitoring Board (DSMB) to continue the Phase 2b clinical trial of AEF0117 in cannabis addiction without any changes to the protocol.The DSMB analyzed the data from the Phase 2b trial of AEF0117. The DSMB is a U.S. committee of independent experts specializing in clinical research that reviews study data with a particular focus on tolerability and safety. The DSMB, which analyzed the data from the Phase 2b trial of AEF0117, met to evaluate the safety and tolerability data for the first 115 patients treated for at least four weeks with AEF0117. Following this important meeting, the committee noted no serious adverse events or significant treatment-related events and recommended that the study continue without any changes to the protocol. The Phase 2b trial 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. This double-blind, placebo-controlled trial is expected to include approximately 330 patients in total. These patients will receive either a placebo or one of the three tested doses of AEF0117 (i.e., 0.1 mg, 0.3 mg, and 1 mg) once daily for three days. The main objective of this study is to evaluate whether AEF0117 reduces cannabis consumption by demonstrating an increase in the proportion of subjects who consume cannabis less than one day per week compared to placebo. The proportion of patients achieving further levels of consumption reduction, as well as the potential improvement in their quality of life, will also be studied. Study recruitment continues at a steady pace, allowing us to anticipate the first results by mid-2024. According to a statement by Pier Vincenzo Piazza, CEO of Aelis Farma: “First and foremost, we would like to thank all the study participants and the investigator teams who are contributing to advancing our understanding of AEF0117 in the critical field of cannabis addiction. This positive recommendation from the DSMB confirms the very good safety and tolerability profile of our drug candidate, already observed during its previous evaluation phases, recently published in Nature Medicine.” The fact that it is safe and well-tolerated in patients under real-life conditions is crucial and very favorable for the continued development of AEF0117, the only molecule that currently represents real hope for many people suffering from pathologies caused by excessive cannabis use.
AEF0117, discovered and being tested by Aelis Farma, is the first drug candidate in the new CB1-SSi pharmacological class, which is based on a natural mechanism used by the brain to combat CB1 receptor hyperactivity.
Source: https://www.newsweed.fr/aelis-farma-recoit-lavis-positif-du-dsmb-pour-la-poursuite-sans-changement-au-protocole-de-son-etude-clinique-de-phase-2b-avec-aef0117-dans-laddiction-au-cannabis/
