Indivior Announces First Patient Included in Aelis Farma's Phase 2b Study Assessing the Efficacy, Safety and Tolerability of AEF0117 in Treatment-Seeking Subjects With Moderate to Severe Cannabis Use Disorder

SLOUGH, England and RICHMOND, Va., June 1, 2022 /PRNewswire/ -- Indivior PLC (LON: INDV) announces the enrollment of the first patient in the Phase 2b study of AEF0117 for the treatment of cannabis use disorder (CUD). This follows less than a year after Indivior and Aelis Farma announced a strategic collaboration that includes an exclusive option and license agreement for the global rights to AEF0117, a first-in-class synthetic Signaling Specific Inhibitor ("SSI") engineered to inhibit the cannabinoid type 1 ("CB1") receptor ("CB1-SSI").

"Following the promising results of a Phase 2a study showing that AEF0117 reduced the subjective effects of cannabis and cannabis self-administration in subjects with moderate to severe CUD, this Phase 2b clinical trial aims at demonstrating the efficacy, tolerability and safety of AEF0117 for the treatment of CUD," said Christian Heidbreder, PhD, Chief Scientific Officer, Indivior. "Excessive cannabis use and its related disorders have become an increasing societal concern. Roughly 200 million people used cannabis in 2019 representing 4% of the global population.¹ In the US, 49.6 million people aged 12 or older used cannabis in 2020 and 14.2 million people had a CUD in the past year during the same period.²"

The Phase 2b, that will be conducted by Aelis Farma, is a randomized, double-blind, placebo-controlled, 4-arm, parallel-group, prospective, multicenter study in treatment-seeking subjects with moderate to severe CUD.  The primary objective of the study is to demonstrate that AEF0117 (0.1, 0.3, or 1 mg once a day for 12 weeks) induces a greater proportion of subjects with a response of ≤1 day of cannabis use per week compared to placebo. The proportion of subjects that reach various levels of reduction of use and how this influences their quality of life will also be investigated. The initiation of this Phase 2b trial represents a key development in the Company's pipeline, which upon completion would enable AEF0117 to move forward into a Phase 3 study in subjects with CUD.

"Indivior has been dedicated to helping patients struggling with substance use disorder for over 25 years," said Mark Crossley, Chief Executive Officer, Indivior. "Currently, cannabis is the most commonly misused substance in the U.S. after alcohol and tobacco.³ We are excited about our collaboration with Aelis Farma and the development of the promising asset AEF0117, which potentially represents a unique opportunity to address a growing unmet public health need."

The United Nations recently estimated that the number of cannabis users increased by nearly 18% over the past decade, and cannabis products almost quadrupled in strength in the US and doubled in Europe in the last two decades (2002-2019).¹ D9-THC, the main psychoactive component in cannabis, is responsible for the development of mental health disorders in long-term, heavy users of cannabis.¹

About AEF0117 Phase 2b Study

This Phase 2b study is part of the clinical development program of AEF0117 that has received a total of $7.8 million in grant from the National Institute of Health (NIH) of which $4.5 million was allocated for this new phase of development.

Background on lead compound AEF0117 & milestones

Aelis' lead CB1-SSi compound AEF0117 is a new chemical entity (NCE) with U.S. composition of matter patent expiry in 2033 and a method of use patent that could extend protection up to 2039.

Completed Phase 1 clinical (single and multiple ascending dose) studies for AEF0117 have suggested good safety and tolerability and a recently completed 29-patient Phase 2a study in subjects with CUD demonstrated positive signals of efficacy and good tolerability ("Effect of AEF0117 on Subjective Effects of Cannabis in CUD Subjects"; ClinicalTrials.gov Identifier: NCT03717272).

Under the Agreement, Aelis will fund and manage the Phase 2b proof of concept study of AEF0117.  Assuming successful completion of the Phase 2b study, the exclusive option gives Indivior the right to assume full control of clinical development and commercialization of AEF0117 in return for a payment to Aelis of $100 million. Phase 3 studies and commercialization would then be at Indivior's direction and expense. Aelis would also be entitled to certain other development and sales milestones, including payments linked to U.S. NDA filing acceptance and NDA approval, as well as royalties in the mid-teen percentage range on global net sales.

About Indivior

Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD) and serious mental illnesses. Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of SUD. Indivior is dedicated to transforming SUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category and potentially address other chronic conditions and co-occurring disorders of SUD, including alcohol use disorder and cannabis use disorder. Headquartered in the United States in Richmond, VA, Indivior employs more than 900 individuals globally and its portfolio of products is available in over 40 countries worldwide. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/indivior.

References:

1. World Drug Report 2021 (United Nations publication, Sales No. E.21.XI.8).
2. Substance Abuse and Mental Health Services Administration. (2021). Key substance use and mental health indicators in the United States: Results from the 2020 National Survey on Drug Use and Health (HHS Publication No. PEP21-07-01-003, NSDUH Series H-56). Rockville, MD: Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration. Retrieved from https://www.samhsa.gov/data/ 
3. Carliner et al. Prevent. Med. 2017; 104:13-23.

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