18.03.2020 06:59:51
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Press Release: Addex Therapeutics Delays Start of Dipraglurant Pivotal Study and Reporting 2019 Full Year Audited Results
Geneva, Switzerland, March 18, 2020 --
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Addex Therapeutics (SIX: ADXN and Nasdaq: ADXN), a clinical-stage
pharmaceutical company pioneering allosteric modulation-based drug
discovery and development, announced today that due to the impact of the
COVID-19 coronavirus pandemic, the start of the registrational efficacy
and safety study (Study 301) of dipraglurant to treat levodopa induced
dyskinesia (PD-LID) in patients with Parkinson's disease has been
postponed. In addition, the company will delay reporting its full year
2019 audited financial results and associated investor conference call
till April 8, 2020.
Addex has taken the decision to postpone the start of the dipraglurant
study due to the fact that the intended patient population is among the
highest risk category for severe illness and death associated with
COVID-19. Public health authorities worldwide have recommended that
people at high risk stay at home as much as possible, cancel all
non-essential doctor's appointments and avoid unnecessary exposure to
people and public spaces.
"As the situation with COVID-19 has evolved, we have stayed in close
communication with study sites, vendors and colleagues and learned of
new institutional precautions being put in place for clinical research.
Sites are temporarily suspending on-site visits for monitors, vendors,
and all other non-patient visitors and several sites have cancelled all
non-essential patient visits," said Roger Mills, M.D., Chief Medical
Officer of Addex Therapeutics. "Priority is now rightly being placed on
how to manage regular care for patients in the light of the increasing
COVID-19 containment requirements. We care about the well-being of all
PD patients and do not wish to have them make the additional visits to
doctors' offices that are required in a clinical study, putting them at
increased risk of contracting COVID-19."
Addex will continue to work with its CRO and the study sites to continue
preparations to start the study as soon as it is appropriate to do so.
About Addex Therapeutics
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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
scheduled to enter a pivotal registration clinical trial for Parkinson's
disease levodopa induced dyskinesia (PD-LID). In parallel,
dipraglurant's therapeutic use in dystonia is being investigated in
preclinical models. Addex's second clinical program, ADX71149 (mGlu2
positive allosteric modulator or PAM) is being developed in
collaboration with Janssen Pharmaceuticals, Inc for the treatment of
epilepsy. In addition, Addex's GABA(B) PAM program has been licensed to
Indivior PLC for the treatment of addiction. Preclinical programs
include GABA(B) 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.
Press Contacts:
Tim Dyer Mike Sinclair
Chief Executive Officer Partner, Halsin Partners
Telephone: +41 22 884 15 55 +44 (0)20 7318 2955
Email: mailto:PR@addextherapeutics.com PR@addextherapeutics.com mailto:msinclair@halsin.com msinclair@halsin.com
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Forward Looking Statements
Certain statements made in this announcement are forward-looking
statements including with respect to the creation of a trading market
for ADSs representing the Company's shares in the United States. These
forward-looking statements are not historical facts but rather are based
on the Company's current expectations, estimates, and projections about
its industry; its beliefs; and assumptions. Words such as 'anticipates,'
'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and
similar expressions are intended to identify forward-looking statements.
These statements are not guarantees of future performance and are
subject to known and unknown risks, uncertainties, and other factors,
some of which are beyond the Company's control, are difficult to predict,
and could cause actual results to differ materially from those expressed
or forecasted in the forward-looking statements. The Company cautions
securityholders and prospective securityholders not to place undue
reliance on these forward-looking statements, which reflect the view of
the Company only as of the date of this announcement. The
forward-looking statements made in this announcement relate only to
events as of the date on which the statements are made. The Company will
not undertake any obligation to release publicly any revisions or
updates to these forward-looking statements to reflect events,
circumstances, or unanticipated events occurring after the date of this
announcement except as required by law or by any appropriate regulatory
authority.
(END) Dow Jones Newswires
March 18, 2020 02:00 ET (06:00 GMT)
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