Indivior Extends Leadership Position in Substance Use Disorder Treatment with Exclusive Agreement for Leading Asset Targeting Cannabis-Related Disorders
Indivior PLC, announced that it is extending its leadership position in substance use disorder (“SUD”) treatment by expanding into the under treated cannabis-related disorders, including cannabis use disorder (“CUD”) and cannabis-induced psychosis (“CIP”). Indivior has entered into a strategic collaboration with Aelis Farma (“Aelis”), a private biotechnology company based in Bordeaux, France, that includes an exclusive option and license agreement (the “Agreement”) for the global rights to AEF0117, Aelis’ first-in-class synthetic Signaling Specific inhibitor (“SSi”) engineered to inhibit the cannabinoid type 1 (“CB1”) receptor (“CB1-SSi”).
Under the Agreement, Indivior will pay an initial $30 million to secure an exclusive global option for AEF0117. In clinical Phase 1 studies, AEF0117 has shown promising safety and tolerability signals. Furthermore, in a recently completed Phase 2a study, AEF0117 has shown positive signals of efficacy in subjects with CUD1. The option gives Indivior the right to assume all development and commercialization activities for AEF0117 upon successful completion of a planned Phase 2b study by Aelis in return for an exercise fee of an additional $100 million and a series of potential milestone payments and sales-based royalties. The Agreement also includes exclusive global rights on a patent covering AEF0117 and related compounds and on a methods of use patent for treating cannabis-related disorders, including CUD and CIP.
“Our heritage and focus at Indivior is helping address unmet needs for people struggling with substance use disorders,” said Mark Crossley, Chief Executive Officer. “Increasing prevalence of cannabis from the growing movement to legalize medical and recreational marijuana use is leading to greater concern for the potential of adverse outcomes, including elevated addiction risk2. Cannabis is the most commonly used substance of abuse in the US after alcohol and tobacco3; however, we have no FDA-approved medications for cannabis-related disorders, which are complex and concerning. AEF0117 is the most advanced new chemical entity under investigation in the clinic and potentially represents a unique opportunity to address a growing unmet public health need.”
Over 48 million4 people used marijuana in the U.S. in 2019 and 4.8 million4 people had a CUD during the same period. The United Nations also recently estimated that 192 million people globally used cannabis in 20185, making it the most used drug in the world. The most recent global burden of disease study including 195 countries over the 1990-2016 period estimated that 22.1 million people met the diagnostic criteria for CUD (289.7 cases per 100,000 people)6.
“We are excited about the potential for our partnership with Aelis,” said Christian Heidbreder, Chief Scientific Officer. “Our collaboration to advance the clinical development of AEF0117 reflects the success of our Connect and Develop R&D strategy that seeks to marry our drug discovery and development capabilities with innovators targeting the most promising pharmacological mechanisms in substance use disorders and related CNS diseases. Favorable data in support of Aelis’ new CB1-SSis have the potential to yield the necessary clinical proof of concept to advance AEF0117 closer to regulatory approval as the first medication to treat CUD.”