THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR
THE PURPOSES OF ARTICLE 7 OF THE MARKET ABUSE REGULATION (EU)
596/2014 (AS IT FORMS PART OF DOMESTIC LAW IN THE UK BY VIRTUE OF
THE EUROPEAN UNION (WITHDRAWAL) ACT 2018).
- Primary and Secondary End Points of the Study were Not
Met
- Indivior Does Not Currently Expect to Exercise AEF0117
Option
SLOUGH, United Kingdom and
RICHMOND, Va., Sept. 4, 2024 /PRNewswire/ -- Indivior
PLC (Nasdaq/LSE: INDV) is today providing an update
following Aelis Farma's announcement of the results from its
clinical Phase 2B trial with
AEF01171, evaluating the efficacy and safety in
treatment-seeking participants with moderate to severe Cannabis Use
Disorder (CUD). The purpose of this trial was twofold: (1) to show
that AEF0117 (0.1, 0.3, 1 mg once a day for 12 weeks) lowers
cannabis use and (2) to determine the endpoints and optimal dosage
of AEF0117 for use in future studies. In this phase 2B study, patients were treatment-seeking
participants, 84% of whom had severe CUD.
The results of the study demonstrated that the primary endpoint,
the proportion of participants who reduced their cannabis use to ≤1
day per week, as well as secondary endpoints measuring the
proportion of participants reaching either complete abstinence or
who used ≤2 day per week, were not met. Although these results are
disappointing, they indicate that significant work remains to be
done to understand subpopulations of patients with CUD,
specifically those with severe CUD.
This clinical Phase 2B study is
part of the strategic collaboration between Aelis Farma and
Indivior, which includes an exclusive option for Indivior to
license the global rights to AEF0117. Given the lack of separation
from placebo on primary and secondary endpoints and before seeing
further additional favorable clinical data, Indivior does not
currently expect to exercise its option.
Important Cautionary Note Regarding Forward-Looking
Statements
This news release contains certain statements that are
forward-looking. Forward-looking statements include, among other
things, express and implied statements regarding whether: we will
be able to ultimately demonstrate the safety and efficacy of
AEF0117, which is a prerequisite to filing any New Drug
Application; we might ever exercise our option for AEF0117 and, if
so, when; and other statements containing the words "believe,"
"anticipate," "plan," "expect," "intend," "estimate," "forecast,"
"strategy," "target," "guidance," "outlook," "potential,"
"project," "priority," "may," "will," "should," "would," "could,"
"can," "outlook," "guidance," the negatives thereof, and variations
thereon and similar expressions. By their nature, forward-looking
statements involve risks and uncertainties as they relate to events
or circumstances that may or may not occur in the future.
Actual results may differ materially from those because they
relate to future events. Various factors may cause differences
between Indivior's expectations and actual results, including,
among others, the risks described in our most recent annual report
on Form 20-F beginning on page 9 as filed with the U.S. SEC and in
subsequent releases; legal and market restrictions that may limit
how quickly we can repurchaser our shares; the substantial
litigation and ongoing investigations to which we are or may become
a party; our reliance on third parties to manufacture commercial
supplies of most of our products, conduct our clinical trials and
at times to collaborate on products in our pipeline; our ability to
comply with legal and regulatory settlements, healthcare laws and
regulations, requirements imposed by regulatory agencies and
payment and reporting obligations under government pricing
programs; risks related to the manufacture and distribution of our
products, most of which contain controlled substances; market
acceptance of our products as well as our ability to commercialize
our products and compete with other market participants;
competition; the uncertainties related to the development of new
products, including through acquisitions, and the related
regulatory approval process; our dependence on third-party payors
for the reimbursement of our products and the increasing focus on
pricing and competition in our industry; unintended side effects
caused by the clinical study or commercial use of our products; our
ability to successfully execute acquisitions, partnerships, joint
ventures, dispositions or other strategic acquisitions; our ability
to protect our intellectual property rights and the substantial
cost of litigation or other proceedings related to intellectual
property rights; the risks related to product liability claims or
product recalls; the significant amount of laws and regulations
that we are subject to, including due to the international nature
of our business; macroeconomic trends and other global developments
such as armed conflicts and pandemics; the terms of our debt
instruments, changes in our credit ratings and our ability to
service our indebtedness and other obligations as they come due;
changes in applicable tax rate or tax rules, regulations or
interpretations and our ability to realize our deferred tax assets;
and volatility in our share price due to factors unrelated to our
operating performance or that may result from the potential move of
our primary listing to the U.S.
Forward-looking statements speak only as of the date that they
are made and should be regarded solely as our current plans,
estimates and beliefs. Except as required by law, we do not
undertake and specifically decline any obligation to update,
republish or revise forward-looking statements to reflect future
events or circumstances or to reflect the occurrences of
unanticipated events.
This release is being made by Kathryn
Hudson, Company Secretary Indivior PLC.
About Indivior
Indivior is a global pharmaceutical company working to help
change patients' lives by developing medicines to treat substance
use disorders (SUD), overdose 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. Headquartered in the United
States in Richmond,
VA, Indivior employs over 1,000 individuals globally and its
portfolio of products is available in over 30 countries worldwide.
Visit www.indivior.com to learn more. Connect with Indivior on
LinkedIn by visiting www.linkedin.com/company/indivior.
References:
- National Library of Medicine (U.S.) (2022, April). Effect of
AEF0117 on treatment-seeking patients with cannabis use disorder
(CUD) (SICA2). Identifier
NCT05322941
https://www.clinicaltrials.gov/study/NCT05322941
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