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On Wednesday, Indivior (LSE:INDV) reported that the Phase 2B clinical trial conducted by Aelis Farma on the drug AEF0117 for treating cannabis use disorder (CUD) did not achieve its primary and secondary endpoints. The trial was designed with two key objectives: to demonstrate that AEF0117 could effectively reduce cannabis use and to establish the optimal dosage and endpoints for future studies.
The primary endpoint of the study was to determine if AEF0117 could reduce cannabis use to less than one day per week among participants. Additionally, the secondary endpoints aimed to assess whether participants could either achieve complete abstinence or reduce their cannabis use to fewer than two days per week. The results indicated that neither of these goals was met.
Indivior, a London-listed pharmaceutical company, expressed disappointment with the findings. The trial did not show a significant difference in outcomes between AEF0117 and a placebo, indicating that the drug did not perform better than the placebo in reducing cannabis use. The company noted that these results underscore the need for further research to better understand patient subpopulations with severe CUD, which might require different treatment approaches.
In response to the trial outcomes, Indivior stated that, given the lack of positive separation from the placebo on the primary and secondary endpoints, and until further favorable clinical data is available, the company does not plan to exercise its option related to AEF0117 at this time. This decision reflects the need for additional data to determine whether the drug could be a viable treatment option for CUD.
As of 0850 BST, Indivior's shares had fallen by 1.86% to 896.0p, reflecting investor reaction to the disappointing trial results. The company is now focused on analyzing the data from the trial and evaluating its next steps in the development of treatments for cannabis use disorder. Indivior continues to explore other avenues in its pipeline while assessing the implications of this trial's outcomes for its overall strategy.
