Pharmaceutical company Indivior PLC (Nasdaq: INDV) (LSE: INDV) reported on Wednesday that the clinical Phase 2B study conducted by Aelis Farma on AEF0117, aimed at treating Cannabis Use Disorder (CUD), did not meet its primary or secondary endpoints. The trial, which included treatment-seeking participants with moderate to severe CUD, evaluated the efficacy of AEF0117 at dosages of 0.1, 0.3, and 1 mg once daily over 12 weeks.
The primary endpoint, reducing cannabis use to ≤1 day per week, and secondary endpoints, including complete abstinence or reduction to ≤2 days per week, were not achieved. These results highlight the ongoing challenges in treating severe CUD and the need for further research to better understand patient subpopulations.
As a result of the trial's outcomes and the lack of significant differentiation from placebo, Indivior does not currently plan to exercise its option to license the global rights to AEF0117 under its strategic collaboration with Aelis Farma.
Indivior, headquartered in Richmond, VA, is committed to developing treatments for substance use disorders (SUD) and related mental health conditions. Despite this setback, the company continues to focus on expanding its portfolio of treatments for opioid use disorder (OUD) and other chronic conditions associated with SUD. Indivior's products are available in over 30 countries, and the company employs more than 1,000 people worldwide.
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