Nicox Announces First Patient Screened in the Whistler Phase 3b Trial of NCX 470 in Glaucoma
December 18 2023 - 12:30AM
Nicox Announces First Patient Screened in the Whistler Phase 3b
Trial of NCX 470 in Glaucoma
Press Release |
Nicox Announces First Patient Screened in the Whistler Phase 3b
Trial of NCX 470 in Glaucoma |
December 18, 2023 – release at 7:30 am CETSophia Antipolis,
FranceNicox SA (Euronext Growth Paris:
FR0013018124, ALCOX), an international ophthalmology company, today
announced that the first patient has been screened in the Whistler
Phase 3b clinical trial investigating the dual mechanism of action
(nitric oxide and prostaglandin analog) of NCX 470 in intraocular
pressure (IOP) lowering. NCX 470, a novel nitric oxide
(NO)-donating bimatoprost eye drop, is our lead product candidate
in Phase 3 clinical development for IOP lowering in patients with
open-angle glaucoma or ocular hypertension. “The model we are using
to investigate the effects on aqueous humor outflow is well
established and we are pleased to be working with one of the
experts in this field, Dr Arthur Sit at the Mayo Clinic. The data
from this trial is expected to provide further evidence of the dual
mechanism of action of NCX 470 as we should be able to tease out
parameters related to how the nitric oxide and the prostaglandin
analog components of NCX 470 function.” said Doug Hubatsch,
EVP, Chief Scientific Officer of Nicox.The Whistler Phase
3b trial will enroll ~20 healthy volunteers with ocular
hypertension in a double-masked, placebo-controlled study which
will investigate the action of NCX 470 on aqueous humor parameters
including trabecular meshwork outflow and episcleral venous
pressure. Each subject will participate in the trial for ~8 days
and will provide insight into the mechanism of action of NCX 470.
The trial is expected to take approximately 1 year to
complete.Nicox Corporate Status UpdateThe Company
is currently funded until the end of June 2024, exclusively on the
basis of the development of NCX 470. The Company is pursuing
licensing discussions which could extend the cash runway. In
parallel, the Company is exploring multiple strategic options and
is also discussing with its creditors to restructure its
debt.About NCX 470NCX 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. Results of Mont Blanc, the first of the two
Phase 3 clinical trials, were announced in October 2022. The second
Phase 3 clinical trial, Denali, is currently ongoing, and the
results are expected in 2025 based on current recruitment rates.
Mont Blanc and Denali have been designed to fulfill the regulatory
requirements for safety and efficacy Phase 3 trials to support NDA
submissions in both the U.S. and in China, where NCX 470 is
exclusively licensed to Ocumension Therapeutics. |
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 eye drop, for lowering
intraocular pressure in patients with open-angle glaucoma or ocular
hypertension. Nicox generates revenue from VYZULTA® in glaucoma,
licensed exclusively worldwide to Bausch + Lomb, and ZERVIATE® in
allergic conjunctivitis, licensed in multiple geographies,
including to Harrow, Inc. 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 Growth Paris (Ticker symbol: ALCOX) 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. |
|
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 report. |
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 section 2.7 of the “Rapport
Annuel 2022” and in section 4 of the “Rapport semestriel financier
et d’activité 2023” 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_NCX 470 Whistler Ph3b FPFV PR_20231218_F
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