Indivior Reports on Aelis Farma's AEF0117 Cannabis Study
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Indivior's Update on Aelis Farma's Phase 2B Cannabis Study
Indivior PLC (Nasdaq/LSE: INDV) has provided an important update regarding the results of Aelis Farma's recent clinical Phase 2B trial focused on AEF0117. This study aimed to examine the efficacy and safety of AEF0117 in participants suffering from Cannabis Use Disorder (CUD), a condition characterized by a problematic pattern of cannabis use leading to clinically significant impairment or distress.
Study Objectives and Results
The trial was intended to accomplish two primary objectives: first, to demonstrate that the administration of AEF0117 (in doses of 0.1, 0.3, and 1 mg once daily over a 12-week period) would lead to a significant reduction in cannabis usage among patients; secondly, to identify effective dosage levels and endpoints for subsequent studies. However, the findings of this Phase 2B study revealed that neither the primary endpoint—reducing cannabis use to one day or less per week—nor the secondary endpoints concerning abstinence were achieved.
84% of trial participants were classified as having severe CUD, which highlights the complexity of this patient population and the challenges faced in treatment. Despite the disappointment surrounding the unmet endpoints, the outcomes underscore the necessity for further research into the diverse subpopulations affected by CUD.
Implications for Indivior
As part of its strategic collaboration with Aelis Farma, Indivior had an exclusive option to acquire global rights for AEF0117. However, in light of the current study results, Indivior is refraining from exercising this option until additional positive clinical data is presented. This cautious approach reflects a commitment to ensuring patient safety and confirming the efficacy of potential treatments before further investment.
Forward-Looking Considerations
While this update features critical forward-looking statements about AEF0117 and its potential use, Indivior acknowledges the inherent risks and uncertainties in drug development. Actual results could vary significantly from expectations due to several influencing factors, including market conditions and regulatory developments.
About Indivior
Indivior is a leading global pharmaceutical company dedicated to transforming the landscape of substance use disorder treatment. By developing innovative medicines, the company's mission is to ensure patients around the world have access to evidence-based therapies that address chronic substance use disorders and co-occurring mental health issues.
Headquartered in Richmond, VA, Indivior employs over 1,000 people and extends its product offerings internationally across more than 30 countries. Developers of treatments for opioid use disorder, Indivior is committed to evolving its portfolio to include new candidates that may address additional chronic conditions.
Frequently Asked Questions
What was the main focus of the Phase 2B trial?
The trial primarily focused on assessing the efficacy and safety of AEF0117 in patients seeking treatment for Cannabis Use Disorder.
What were the outcomes of this clinical study?
The study did not meet its primary and secondary endpoints, indicating challenges in demonstrating cannabis use reduction effectively.
What does Indivior plan to do following these results?
Indivior currently does not plan to exercise its option for AEF0117 until further favorable clinical data becomes available.
How does this impact Indivior's drug development strategy?
This situation highlights the cautious approach Indivior takes in its drug development strategy, focusing on safety and efficacy before proceeding with licensing.
What is Indivior's mission?
Indivior’s mission is to change patients' lives by ensuring access to effective treatments for substance use disorders globally.
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