Addex Therapeutics Initiates Phase 2 Clinical Study with Dipraglurant in Blepharospasm
29 September 2021 - 3:00PM
Addex Therapeutics Initiates Phase 2 Clinical Study with
Dipraglurant in Blepharospasm
Type of dystonia
characterized by involuntary spasms of the eyelid
muscles can lead to substantial visual disturbance
or functional blindness
Ad Hoc Announcement Pursuant to
Art. 53 LR
Geneva,
Switzerland, September
29,
2021 -
Addex Therapeutics Ltd (SIX: ADXN, Nasdaq: ADXN), a clinical-stage
pharmaceutical company pioneering allosteric modulation-based drug
discovery and development, announced today the initiation of a
Phase 2a clinical study with dipraglurant as a potential
treatment for blepharospasm, a type of dystonia characterized by
involuntary contractions or spasms of the eyelid muscles resulting
in sustained eyelid closure, which can result in substantial visual
disturbance or functional blindness. Dipraglurant selectively
targets the metabotropic glutamate receptor subtype 5 (mGlu5) to
downregulate neurotransmission through allosteric modulation.
This double-blind, randomized Phase 2a
feasibility study will enroll 15 patients with blepharospasm. It is
designed to assess the safety and tolerability of dipraglurant (50
and 100mg) as well as explore its effects on the severity and
frequency of blepharospasm signs and symptoms using objective
measures, clinical ratings and patient reported outcomes. Data from
the study are expected in Q1 2022.
“The only approved therapy for blepharospasm is
muscular injections of botulinum neurotoxin, but symptoms often
recur well before a patient can receive their next injection
cycle,” said Roger Mills, Chief Medical Officer of Addex. “By
modulating the overexcitation signal causing the blink reflex to
malfunction, dipraglurant may provide an oral therapy for patients
with blepharospasm that reduces the severity and frequency of
symptoms, and thereby reduces pain, which consequently improves
daily function and quality of life.”
“This study in blepharospasm is the third
clinical study we have started this year, a significant
achievement, particularly during these challenging times,” said Tim
Dyer, Chief Executive Officer of Addex. “We are now poised for a
significant year of reporting data in 2022, with results from this
initial blepharospasm study in Q1 and top-line data from our
pivotal study of dipraglurant in levodopa induced dyskinesia in
Parkinson’s and for ADX71149 in epilepsy later in 2022.”
Blepharospasm is a form of dystonia
characterized by involuntary contractions or spasms. It currently
affects around 50,000 people in the US, with approximately 2,000
new cases diagnosed each year. The cause of blepharospasm is
thought to involve overstimulation of the blink reflex resulting
from excessive glutamate stimulation. Botulinum toxin injections
are the only approved drug treatment.
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), in addition to the Phase 2 clinical
study for blepharospasm. 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 ongoing with Addex 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.
Contacts:
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.
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