REG - Indivior PLC - First patient enrolled in AEF0117 Phase 2b study

IndiviorAnnouncement

01/06/2022 13:00

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RNS Number : 5483N  Indivior PLC  01 June 2022

 

 

 

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, UK and Richmond, VA - June 1, 2022 - 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
(http://www.linkedin.com/company/indivior) .

Media Contacts:

UK

Tulchan Communications

+44 207-353-4200

 

US

IndiviorMediaContacts@indivior.com

+1 804-594-0836

 

Investor Contact:

Jason Thompson

Vice President, Investor Relations

Indivior PLC (LON: INDV)

Mobile: 804-402-7123

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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