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 |
Bryan, Garnier & Co
Hugo Solvet Paris, FranceInvest Securities
Martial Descoutures Paris, FranceGilbert Dupont
Damien Choplain Paris, France Stifel Olivia
Manser London, UK |
|
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Contacts |
NicoxGavin Spencer,Executive Vice President Corporate
Development T +33 (0)4 97 24 53 00communications@nicox.com |
Investor
RelationsEurope NewCap Julien Perez, Valentine BrouchotT +33
(0)1 44 71 94 94nicox@newcap.eu |
Media Relations
United Kingdom Jonathan BirtT +44 7860 361
746jonathan.birt@ymail.com |
United States Argot
Partners Melissa ForstT +1 (212)
600-1902melissa@argotpartners.com |
France NewCapNicolas
MerigeauT +33 (0)1 44 71 94 98nicox@newcap.eu |
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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 |
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