Addex Provides Year End Pipeline Development Update
December 15 2021 - 1:00AM
Ad Hoc Announcement Pursuant to Art. 53
LR
Geneva, Switzerland, 15
December 2021 - Addex
Therapeutics (SIX: ADXN and Nasdaq: ADXN), a clinical-stage
pharmaceutical company pioneering allosteric modulation-based drug
discovery and development, today provided an update on progress in
its product pipeline.
“During 2021, we made great progress across our
clinical pipeline and now have three active programs set to start
delivering data as early as the first quarter of 2022. We are also
making great progress in our earlier stage pipeline, with three
programs on track to enter IND enabling studies in 2022,” said Tim
Dyer, CEO of Addex.
Pipeline Update
- Dipraglurant Study 301 for
Parkinson’s disease levodopa-induced dyskinesia (PD-LID): We
initiated a pivotal Phase 2B/3 study in June 2021 and are making
solid progress with activating sites and enrolling patients. We
expect to report top-line data at the end of Q4 2022. In parallel
we have activated Study 302, a 12-month open label safety study,
and enrolment of patients from Study 301 into this study is
progressing as planned.
- Dipraglurant Study 203 for
blepharospasm: Enrolment is progressing as planned and we expect
top-line data around the end of Q1 2022. Blepharospasm is a type of
dystonia characterized by involuntary muscle contractions and
spasms of the eyelid muscles resulting in sustained eyelid closure,
which can cause substantial visual disturbance or functional
blindness.
- ADX71149: Our partner, Janssen
Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies
of Johnson & Johnson, is progressing well with a Phase 2a
clinical study of ADX71149 in epilepsy patients. Data from this
study is expected during Q3 2022. Recently, we announced that Phase
1 studies in Japan had been successfully completed, allowing Japan
to be included in a potential future global development
program.
- GABAB PAM for substance use
disorder and Charcot-Marie-Tooth type 1A neuropathy (CMT1A): We are
advancing several drug candidates through clinical candidate
selection phase and expect to initiate IND enabling studies in
2022. During 2021, we extended our strategic collaboration with
Indivior in substance use disorder until mid-2022, securing
$4million in additional funding. We also entered into a
collaboration with the Charcot–Marie–Tooth Association to evaluate
selected drug candidates in preclinical models of CMT1A.
- mGlu7 NAM for post-traumatic stress
disorder: We have started clinical candidate selection phase with
our lead series and continue in late lead optimization with
multiple back-up series of compounds. We expect to initiate IND
enabling studies in 2022. This program is partially funded by a
grant from Eurostars / Innosuisse.
- mGlu2 NAM for mild neurocognitive
disorders associated with Alzheimer’s disease, Parkinson’s disease
and depressive disorders: We are in late lead optimization phase
with multiple series of compounds and expect to enter clinical
candidate selection phase early in 2022.
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, dipraglurant (mGlu5
negative allosteric modulator or NAM), is in a pivotal registration
clinical trial for Parkinson’s disease levodopa induced dyskinesia
(PD-LID) and has entered a Phase 2 clinical study for the treatment
of blepharospasm, a form of dystonia. Addex's third clinical
program, ADX71149 (mGlu2 positive allosteric modulator or PAM),
developed in collaboration with Janssen Pharmaceuticals, Inc., is
in a Phase 2a proof of concept clinical trial for the treatment of
epilepsy. Indivior PLC has licensed Addex’s GABAB PAM program for
the development of drug candidates with a focus in addiction.
Preclinical programs include GABAB PAM for CMT1A, mGlu7 NAM for
PTSD, mGlu2 NAM for mild neurocognitive disorders, mGlu4 PAM for
Parkinson’s disease and mGlu3 PAM for neurodegenerative disorders.
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.
Contact:
Tim DyerChief Executive OfficerTelephone: +41 22 884 15
55 PR@addextherapeutics.com |
Mike SinclairPartner, Halsin Partners+44 (0)20 7318
2955msinclair@halsin.com |
James
CarbonaraHayden IR(646)-755-7412james@haydenir.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 in respect of the
anticipated initiation of clinical trials. 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 the Company’s Annual Report on Form 20-F filed with
the SEC on March 11, 2021, as well as market conditions and
regulatory review. 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.
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, except as
required by law.
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