Indivior Updates on Aelis Farma's Phase 2B Study Results for AEF0117 in Cannabis Use Disorder Participants

Indivior PLC has provided an update following Aelis Farma's announcement regarding the results of its Phase 2B trial of AEF0117, a drug intended to treat moderate to severe Cannabis Use Disorder (CUD). This trial's primary objectives were to demonstrate that AEF0117 could reduce cannabis consumption and to identify the optimal dosage and endpoints for future studies. The trial included treatment-seeking participants, with a significant 84% suffering from severe CUD.

The Phase 2B trial involved administering AEF0117 at doses of 0.1, 0.3, and 1 mg once daily for 12 weeks. Unfortunately, the study did not meet its primary endpoint, which was the proportion of participants who reduced their cannabis use to one day per week or less. Additionally, the secondary endpoints, which included achieving complete abstinence or reducing use to two days per week or less, were also not met. These results underscore the complexity of treating severe CUD and suggest that further research is necessary to identify effective treatments for different patient subpopulations.

This Phase 2B study is a part of a strategic collaboration between Aelis Farma and Indivior, which includes an exclusive option for Indivior to license the global rights to AEF0117. However, due to the lack of significant difference from the placebo in primary and secondary endpoints, Indivior does not currently expect to exercise this option unless additional favorable clinical data emerges.

Indivior is a global pharmaceutical company focused on developing treatments for substance use disorders (SUD), overdoses, and serious mental illnesses. The company's vision is to ensure that all patients globally have access to evidence-based treatment for the chronic conditions and co-occurring disorders associated with SUD. Indivior aims to transform SUD from a widespread human crisis into a recognized and treatable chronic disease.

Indivior's portfolio is built on treatments for opioid use disorder (OUD), and it continues to develop product candidates to expand its impact in this category and potentially address other chronic conditions related to SUD. Headquartered in Richmond, VA, Indivior employs more than 1,000 individuals worldwide, and its products are available in over 30 countries. The company is dedicated to improving patient outcomes and ensuring access to effective treatments for those struggling with addiction and related disorders.