Addex ADX71149 Phase 2 Epilepsy Study Expected to Readout Data in Q2 2024
05 Septiembre 2023 - 12:00AM
- Cohort
1 is
completed, and
Cohort 2 is 80%
recruited
Ad Hoc Announcement Pursuant to
Art. 53 LR
Geneva, Switzerland,
September 5,
2023 - Addex
Therapeutics (SIX and Nasdaq: ADXN), a clinical-stage
pharmaceutical company pioneering allosteric modulation-based drug
discovery and development, today announced that the ADX71149
(JNJ-40411813) Phase 2 epilepsy clinical study is progressing well,
with Cohort 1 completed and 80% of patients recruited into Cohort
2. Results evaluating the efficacy, safety and tolerability of
ADX71149 in combination with levetiracetam or brivaracetam from
patient Cohorts 1 and Cohort 2 are anticipated for the second
quarter of 2024. The primary efficacy endpoint of this study is
time to baseline monthly seizure count. Collaboration partner
Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical
Companies of Johnson & Johnson, is responsible for the clinical
development of ADX71149.
As previously announced on May 10, 2023, an
independent Interim Review Committee (IRC) convened by our
collaboration partner recommended to continue the study following
review of unblinded data from Part 1 of patient Cohort 1.
“We are very happy with the progress made by our
partner in this study testing the efficacy of ADX71149 in epilepsy
patients and to be able to provide guidance on the expected release
of results in the second quarter of 2024,” said Tim Dyer, CEO of
Addex. “As a reminder, the recommendation of the IRC following the
review of unblinded data from Cohort 1 and the decision of our
collaboration partner to advance into Cohort 2 is very encouraging
for this patient population.”
ADX71149 is a selective metabotropic glutamate
sub-type 2 (mGlu2) receptor positive allosteric modulator (PAM).
The multi-center Phase 2 study has been designed to assess the
efficacy, safety, tolerability, and pharmacokinetics of adjunctive
ADX71149 administration in patients with focal onset seizures with
suboptimal response to levetiracetam or brivaracetam. The primary
objective of the study is to evaluate the efficacy of ADX71149 in
combination with levetiracetam or brivaracetam using a time to
baseline seizure count endpoint. Part 1 of the study evaluates the
acute efficacy of ADX71149 over 4 weeks. Subjects who do not reach
their monthly baseline seizure count in Part 1 continue
double-blind treatment during Part 2 until they reach their monthly
baseline seizure count or 8 weeks, deemed the maintenance efficacy
phase.
In addition, patients who complete Part 1 and/or
Part 2 of the study have the option to continue treatment in the
open-label extension part of the study, which evaluates the
long-term efficacy and safety of ADX71149. More information on the
study can be found with Clinicaltrials.gov identifier
NCT04836559.
About Glutamate mGlu2 Receptors and
Epilepsy:Glutamate is the primary excitatory
neurotransmitter in the brain and plays a key role in the
initiation and spread of seizures. When activated, the mGlu2
receptor decreases the release of glutamate and consequently, helps
to maintain neurotransmitter balance. In the presence of
agonist-induced activation, positive allosteric modulation of mGlu2
receptors could result in the normalization of the excessive
glutamate release seen during a seizure. There is still an urgent
need for more effective treatments for epilepsy, with improved
tolerability and safety. ADX71149 was described in the Eilat 15
conference summary review as a promising novel approach currently
in development (Bialer et al., 2020. Epilepsia). Proof of concept
data with ADX71149 and other mGlu2 PAMs in animal models of
epilepsy have been published in peer-reviewed journals (Metcalf et
al., 2017 and 2018. Epilepsia).
About Our Collaboration:Under
the research collaboration and license agreement, Addex granted
Janssen Pharmaceuticals, Inc. an exclusive worldwide license to
develop and commercialize mGlu2 PAM compounds including ADX71149.
Addex is eligible for up to a total of €109 million in
success-based development and regulatory milestone payments. In
addition, Addex is eligible for low double-digit royalties on net
sales of compounds developed under the agreement.
About Addex
Therapeutics: Addex Therapeutics is a clinical-stage
pharmaceutical company focused on the development and
commercialization of an emerging class of novel orally available,
small molecule drugs known as allosteric modulators for
neurological disorders. Allosteric modulators offer several
potential advantages over conventional, non-allosteric molecules
and may offer an improved therapeutic approach to conventional
"orthosteric" small molecule or biological drugs. Addex's
allosteric modulator drug discovery platform targets receptors and
other proteins that are recognized as essential for therapeutic
intervention. Addex's lead drug candidate, ADX71149 (mGlu2 positive
allosteric modulator or PAM) is in a Phase 2 clinical trial for the
treatment of epilepsy. The company’s second clinical program,
dipraglurant (mGlu5 negative allosteric modulator or NAM), is under
evaluation for future development in post-stroke recovery. Indivior
PLC has licensed Addex’s GABAB PAM program for the development of
drug candidates, with a focus on substance use disorder. Addex is
also advancing a broad preclinical pipeline, which includes
development of a range of GABAB PAM for chronic cough, mGlu7 NAM
for stress related disorders, M4 PAM for schizophrenia and other
forms of psychosis and mGlu2 NAM for mild neurocognitive disorders
and depression. Addex shares are listed on the SIX Swiss Exchange
and American Depositary Shares representing its shares are listed
on the NASDAQ Capital Market, and trade under the ticker symbol
"ADXN" on each exchange.
Contacts:
Tim Dyer Chief Executive Officer Telephone: +41 22 884 15
55 PR@addextherapeutics.com |
Mike Sinclair Partner, Halsin Partners +44 (0)7968
022075 msinclair@halsin.com |
Addex Forward Looking
Statements: This press release contains
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995, as amended, including
statements about the intended use of proceeds of the offering. The
words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,”
“anticipate,” “intend,” “believe,” “estimate,” “predict,”
“project,” “potential,” “continue,” “target” and similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. Any forward-looking statements in this press
release, are based on management's current expectations and beliefs
and are subject to a number of risks, uncertainties and important
factors that may cause actual events or results to differ
materially from those expressed or implied by any forward-looking
statements contained in this press release, including, without
limitation, uncertainties related to market conditions. These and
other risks and uncertainties are described in greater detail in
the section entitled “Risk Factors” in Addex Therapeutics’ Annual
Report on Form 20-F for the year ended December 31, 2022, as filed
with the SEC on March 30, 2023, the final prospectus supplement and
accompanying prospectus and other filings that Addex Therapeutics
may make with the SEC in the future. Any forward-looking statements
contained in this press release represent Addex Therapeutics’ views
only as of the date hereof and should not be relied upon as
representing its views as of any subsequent date. Addex
Therapeutics explicitly disclaims any obligation to update any
forward-looking statements.
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