Press Release |
Nicox provides clinical and regulatory update for NCX 470 for
IOP lowering
-
Positive pre-IND meeting with
FDA completed
-
Expect to file IND in Q4 2017
-
First-in-Human Phase 2 clinical
study expected to start in Q1 2018
|
January 24,
2017
Sophia
Antipolis, France
Nicox S.A. (Euronext Paris: FR0013018124,
COX), the international ophthalmic R&D company, today provided
certain regulatory and clinical updates for NCX 470, its novel
nitric oxide (NO) donating bimatoprost analog being developed for
intraocular pressure (IOP) lowering. Increased IOP is one of
the principal risk factors of open-angle glaucoma and ocular
hypertension.
Nicox held a pre-Investigational New Drug (IND) meeting with the
U.S. Food and Drug Administration (FDA) at the end of 2016.
Based on the feedback from this meeting, Nicox is finalizing the
design of a first-in-human trial for NCX 470 which will be a Phase
2 multi-center, investigator masked, 28-day, parallel group,
dose-finding study in adult subjects with elevated IOP due to
open-angle glaucoma or ocular hypertension. Multiple doses of
NCX 470 will be compared in safety and efficacy to
bimatoprost. The primary endpoint of the study is the mean
reduction in IOP, and the objective is to identify the appropriate
safe and effective dose of NCX 470 to be taken into Phase 3
studies. Recruitment of subjects is expected to begin in
early 2018, subject to IND filing and acceptance1, and
the study is expected to take approximately 1 year to
complete.
Dr. Mike Bergamini, EVP and Chief Scientific
Officer of Nicox commented, "All
pharmacological treatments currently available and in advanced
stages of development for glaucoma target the lowering of IOP as
each additional mmHg reduction results in a 10 to 20% reduced risk
of vision loss. NCX 470 has been developed using a similar
NO-donation platform to latanoprostene bunod, the Nicox molecule
being developed for IOP lowering by our partner Bausch + Lomb,
which is expected to launch in the U.S. in mid-2017. We
believe the clinical results of latanoprostene bunod validate the
mechanism of action of NO-donating prostaglandin analogs, and we
expect NCX 470 to also demonstrate considerable IOP lowering
activity. Our R&D team is currently finalising the
necessary pre-IND activities to support filing of the IND in Q4
this year, allowing us to enroll subjects directly into Phase 2 in
early 2018."
"NCX 470 is the second candidate molecule for
which we have recently announced plans to move into the clinic
within the next 12 months, further solidifying our broad pipeline
of programs in ophthalmology," said Michele
Garufi, Chairman and Chief Executive Officer of Nicox, adding,
"As with latanoprostene bunod, NCX 470 has been
generated by our dedicated and experienced team of researchers who
are leaders in studying the role of NO in the eye. In
addition to our clinic-ready programs, we are working on other new
and innovative NO-based projects currently focused on IOP lowering
and glaucoma, including our proprietary next-generation of
stand-alone NO-donors."
About NO and NO-donating drugs
Nitric oxide (NO) is an endogenous cell-signalling molecule of
fundamental importance in physiology. Nicox has developed a
world-leading position in the therapeutic application of
NO-donating compounds, based on a strong research platform which
creates New Molecular Entities (NMEs). These compounds, known
as NO-donors, are designed to donate nitric oxide with a sustained
pharmacological effect at tissue level aiming at avoiding the
drawbacks related to the rapid burst of NO associated with
traditional nitrates. NO and other messengers involved in
NO-mediated signalling are present in ocular tissues, and NO plays
a role in the regulation of IOP, believed to be by improving
outflow of aqueous humor from the eye through the trabecular
meshwork/Schlemm's canal, a mechanism which is complementary to
that of prostaglandin analogs.
About NCX 470
NCX 470 is a proprietary novel nitric oxide (NO) donating
bimatoprost analog discovered in Nicox's Research Laboratories.
Nicox owns worldwide rights to NCX 470.
In three preclinical models of glaucoma and ocular hypertension,
NCX 470 appeared well-tolerated and more effective than equimolar
bimatoprost in reducing intraocular pressure (IOP)2.
Notably, in a preclinical model in which prostaglandin
analogs are known to be inactive, NCX 470 lowered IOP suggesting
that its nitric oxide-donating moiety produces an IOP-lowering
effect. Bimatoprost, marketed under the brand name
Lumigan®3, is one of
the leading products in the class of prostaglandin analogs, the
most widely used class of IOP lowering drugs. Based on the
positive Phase 3 results for latanoprostene bunod and increased
interest in the potential of nitric oxide (NO)-donors in
ophthalmology, Nicox's Board of Directors selected NCX 470 as the
lead follow-on glaucoma candidate for internal
development.
About glaucoma
Glaucoma is a group of ocular diseases in which the optic nerve is
injured, leading to the loss of the peripheral visual field and can
eventually lead to blindness if not treated. Glaucoma is
frequently linked to abnormally high pressure in the eye, due to
blockage or malfunction of the eye's drainage system. In
2010, open-angle glaucoma (the most common form of glaucoma) was
estimated to affect 8 million individuals in the 7 worldwide major
markets (US, Japan, UK, France, Germany, Italy, Spain)4. |
Notes:
-
Once an IND has been filed, the FDA has 30 days
to notify the sponsor of any questions they have. In the
absence of questions, or once any questions from the FDA have been
resolved, the sponsor may start the clinical study detailed in the
IND
-
Impagnatiello F, Bastia E, Toris CB, Krauss AH,
Prasanna G, Ongini E, NCX 470, a nitric oxide (NO)-donating
bimatoprost lowers intraocular pressure in rabbits, dogs and
non-human primate models of glaucoma. Abstract No. 5809. Presented
at ARVO 2015.
-
Lumigan is a registered trademark of Allergan,
Inc
-
The Ophthalmic Pharmaceutical Market Outlook to
2016 - Business Insight, Sept 2011, BI00042-019
|
About Nicox |
Nicox is an international ophthalmic R&D company
utilizing innovative science to maintain vision and improve ocular
health. By leveraging its proprietary expertise in nitric
oxide donation and other technologies, the Company is developing an
extensive portfolio of novel therapies that target multiple
ophthalmic conditions, including glaucoma. Nicox currently
has two products at the pre-approval stage with the U.S. Food and
Drug Administration (FDA) and a promising pipeline including
next-generation stand-alone nitric-oxide donors, with the potential
to treat a range of ophthalmic indications. Nicox is
headquartered in Sophia Antipolis, France, is listed on Euronext
Paris (Compartment B: Mid Caps; Ticker symbol: COX) and is part of
the CAC Healthcare, CAC Pharma & Bio and Next 150
indexes.
For more information on Nicox, its products or pipeline, please
visit: www.nicox.com
. |
Analyst coverage |
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Paris, France
Invest Securities
Martial Descoutures Paris, France
Gilbert Dupont
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France
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Olivia Manser
London, UK |
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T +33 (0)4 97 24 53 00
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Disclaimer |
The information contained in this document may be modified
without prior notice. This information includes forward-looking
statements. Such forward-looking statements are not guarantees of
future performance. These statements are based on current
expectations or beliefs of the management of Nicox S.A. and are
subject to a number of factors and uncertainties that could cause
actual results to differ materially from those described in the
forward-looking statements. Nicox S.A. and its affiliates,
directors, officers, employees, advisers or agents, do not
undertake, nor do they have any obligation, to provide updates or
to revise any forward-looking statements. |
Nicox S.A.
Drakkar 2
Bât D, 2405 route des Dolines
CS 10313, Sophia Antipolis
06560 Valbonne, France
T: +33 (0)4 97 24 53 00
F: +33 (0)4 97 24 53 99 |