New Data on Two Nicox’s Assets, NCX 470 and NCX 1728, Presented at ARVO 2023
April 26 2023 - 12:30AM
New Data on Two Nicox’s Assets, NCX 470 and NCX 1728, Presented at
ARVO 2023
Press Release |
New Data on Two Nicox’s Assets, NCX 470 and NCX 1728, Presented at
ARVO 2023 |
April
26, 2023 – release at 7:30 am CET Sophia Antipolis,
FranceNicox SA (Euronext Paris: FR0013018124,
COX), an international ophthalmology company, today announced that
studies highlighting nonclinical data on NCX 470 and NCX 1728 have
been presented at the Association for Research in Vision and
Ophthalmology (ARVO) Annual Meeting 2023 being held April 23-27,
2023 in New Orleans, LA, United States.Poster title: NCX
470, a nitric oxide (NO)-donating
bimatoprost, preserves rabbit eyes from
biochemical and functional changes associated with endothelin-1
(ET-1)-induced ischemia/reperfusion injury of optic nerve head and
retina. Retina and optic nerve head vascular dysfunction
in glaucoma is an important therapeutic target. Effectively
managing the ocular blood flow may slow the progressive worsening
of retinal cell function seen in glaucoma patients. This work shows
compelling new evidence of retinal cell protective activity with
NCX 470 in addition to its IOP lowering ability. Specifically, NCX
470 is found to reverse both hemodynamic and retinal cell
impairments consequent to ET-1 induced ischemia/reperfusion injury
in rabbits.NCX 470, a novel NO-donating bimatoprost eye drop, is
currently in Phase 3 clinical development for the lowering of IOP
in patients with open-angle glaucoma or ocular hypertension. Mont
Blanc, the first of the two Phase 3 clinical trials, has been
completed and the results announced in October 2022. The second
Phase 3 clinical trial, Denali, is currently ongoing, and the
results are expected in 2025. Mont Blanc and Denali trials have
been designed to fulfill the regulatory requirements for safety and
efficacy Phase 3 trials to support NDA submissions in the U.S. and
China. Two new Phase 3b clinical trials to evaluate the dual
mechanism of action (NO and prostaglandin analog) in IOP lowering
and the potential retinal benefits of NCX 470 are planned to start
in H1 2023.Paper presentation
title: NCX 1728, a nitric oxide (NO)-donating
phosphodiesterase type-5 inhibitor, but not its des-nitro
derivative (NCX 1880), enhances ocular perfusion and improves
photoreceptor function in rabbits with endothelin-1 (ET-1)-induced
ischemia/reperfusion injury of optic nerve head and
retina. Nitric oxide has a well-established role in ocular
blood flow and visual function. This work shows for the first time
that our NO-donating avanafil derivative, NCX 1728, abolishes ET-1
induced retinal and vascular dysfunction in rabbits. Data point to
nitric oxide/soluble guanylyl cyclase signaling pathway stimulation
as the main contributor for these effects. NCX 1728 holds promise
for the treatment of retinopathies where dysfunctional ocular
perfusion and neovascularization are key pathophysiological
features in disease progression.NCX 1728 is an NO-donating
phosphodiesterase-5 (PDE5) inhibitor, the lead compound of a new
class of NO-donating molecules based entirely on NO-mediated
activity. NCX 1728 is currently under preclinical evaluation for
development in retinal conditions. |
About Nicox |
Nicox SA is an international ophthalmology company developing
innovative solutions to help maintain vision and improve ocular
health. Nicox’s lead program in clinical development is NCX 470, a
novel nitric oxide-donating bimatoprost, for lowering intraocular
pressure in patients with open-angle glaucoma or ocular
hypertension. The company is also conducting research on NCX 1728,
a nitric oxide-donating phosphodiesterase 5 inhibitor, in retinal
conditions. NCX 4251, a novel, patented, ophthalmic suspension of
fluticasone propionate nanocrystals for topical ocular application
for dry eye disease, is being developed by Ocumension Therapeutics
in China under an exclusive license agreement and is available for
partnering elsewhere. Nicox generates revenue from VYZULTA® in
glaucoma, licensed exclusively worldwide to Bausch + Lomb, and
ZERVIATE® in allergic conjunctivitis, licensed in multiple
geographies, including to Eyevance Pharmaceuticals, LLC (a wholly
owned subsidiary of Santen Pharmaceutical Co., Ltd.), in the U.S.
and Ocumension Therapeutics in the Chinese and in the majority of
Southeast Asian markets. Nicox, headquartered in
Sophia Antipolis, France, is listed on Euronext Paris (Compartment
C: Mid Caps; Ticker symbol: COX) and is part of the CAC Healthcare
index.For more information on Nicox, its products or pipeline,
please visit: www.nicox.com. |
Analyst coverage |
Bryan, Garnier & Co
Eric
Yoo Paris,
FranceEdison Investment
Research Pooya
Hemami London,
UKH.C. Wainwright &
Co Yi
Chen New York,
U.S.Kepler
Cheuvreux Arsene
Guekam Paris,
France |
|
The views expressed by analysts in their coverage of Nicox are
those of the author and do not reflect the views of Nicox.
Additionally, the information contained in their reports may not be
correct or current. Nicox disavows any obligation to correct or to
update the information contained in analyst reports. |
Contacts |
|
NicoxGavin SpencerExecutive Vice President, Chief
Business Officer& Head of Corporate Development T +33 (0)4 97
24 53 00communications@nicox.com |
|
Forward-Looking Statements |
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.Risks factors which are likely to have a material effect
on Nicox’s business are presented in the 3rd chapter of the
‘Document d’enregistrement universel, rapport financier annuel et
rapport de gestion 2021’ filed with the French Autorité des Marchés
Financiers (AMF) on April 29, 2022 whose first amendment has been
filed with the AMF on May 19, 2022, in the 2nd chapter of the
second amendment filed with the AMF on November 22, 2022 and in the
2nd chapter of the Securities noted filed with the AMF on November
22, 2022 which are available on Nicox’s website
(www.nicox.com) |
Nicox S.A.Drakkar 2Bât D, 2405 route des
Dolines06560 Valbonne, FranceT +33 (0)4 97 24 53 00F +33 (0)4 97 24
53 99 |
|
- EN_ARVO 2023 PR_F_20230426
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