Addex Announces ADX71149 Phase 2 Epilepsy Clinical Study’s Independent Interim Review Committee Recommends Continuing Study
10 Maggio 2023 - 7:00AM
Addex Announces ADX71149 Phase 2 Epilepsy Clinical Study’s
Independent Interim Review Committee Recommends Continuing Study
- Cohort
1 progressing through Part
2
- Cohort
2 recruiting patients
Ad Hoc Announcement Pursuant to
Art. 53 LR
Geneva, Switzerland,
May 10, 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
has been recommended to continue by an Independent Interim Review
Committee (IRC) following review of unblinded data from Part 1 of
patient Cohort 1. The clinical study is being conducted by Janssen
Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies
of Johnson & Johnson.
“The recommendation of the IRC and the decision
of our collaboration partner to continue the study is very
encouraging and suggests ADX71149 is potentially safe and well
tolerated and may have a positive impact on this patient
population,” said Tim Dyer, CEO of Addex. “We look forward to
providing further updates on the progression of this important
clinical study in the second half of this year.”
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. Up to 3 doses
(low, medium, high) of ADX71149 in up to 160 patients will be
evaluated. 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 or exceed 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. Cohort 1 has completed Part
1 and is currently in Part 2. Cohort 2 has started to recruit
patients in Part 1. 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 for up to 2 years.
More information on the study can be found with Clinicaltrials.gov
identifier NCT04836559.
Glutamate mGlu2 Receptors and
EpilepsyGlutamate 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
CollaborationUnder 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 TherapeuticsAddex
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. Addex's second
clinical program, dipraglurant (mGlu5 negative allosteric modulator
or NAM), is under evaluation for future development in a range of
indications. 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 PAMs for CMT1A,
chronic cough and several types of pain, mGlu7 NAM for stress
related disorders, mGlu2 NAM for mild neurocognitive disorders and
depression, M4 PAM for schizophrenia and other forms of
psychosis, as well as mGlu4 PAM and mGlu3 PAM. 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.
Press Contacts
Tim DyerChief Executive OfficerTelephone: +41 22 884 15
55PR@addextherapeutics.com |
Mike SinclairPartner, Halsin Partners+44 (0)7968
022075msinclair@halsin.com |
Forward Looking StatementsThis
press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995, as
amended, including the ability to discover molecules as part of the
Indivior collaboration, the progress of clinical trials and
preclinical studies, including the timing of data read-outs from
the ADX71149 epilepsy study, and our intended strategic direction.
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, such as receipt of ongoing research payments and timing of
the collaboration conclusion, 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, 2021, as filed with the SEC on March 10, 2022, the
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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