French biotechnology company Aelis Farma has announced disappointing results from its Phase 2B clinical trial for AEF0117, a potential treatment for moderate to severe cannabis use disorder (CUD). The trial, which aimed to assess the efficacy and safety of AEF0117, failed to meet its primary endpoint of reducing cannabis use to one day or less per week. It also did not meet other goals, such as getting participants to stop using marijuana completely or reduce their consumption to two days or less per week.
Aelis Farma noted that the placebo effect was very low, suggesting that participants in the study might be resistant to changing their cannabis usage patterns. However, AEF0117 was well-tolerated, and no safety concerns were observed during the trial.
This clinical trial was part of a strategic collaboration between Aelis Farma and Indivior PLC, a global pharmaceutical company focused on developing medicines for substance use disorders and serious mental illnesses. Indivior had an exclusive option to license the global rights to AEF0117. In light of the trial results, Indivior has announced that it does not currently plan to exercise its option, citing the lack of separation from placebo on primary and secondary endpoints.
Indivior and Aelis Farma previously entered into a collaboration agreement in 2021, with Indivior paying $30 million for the option to license AEF0117. The drug is a first-in-class synthetic signaling specific inhibitor designed to inhibit the cannabinoid type 1 receptor.
Following the announcement of the trial results, Indivior’s shares traded down 0.25% at $12.14 per share at market close Wednesday. The disappointing results of the Aelis Farma trial represent a setback in the search for effective treatments for cannabis use disorder. Further research and development will be necessary to identify potential therapies for this condition.
