Nicox Announces Recruitment of Last Patient in U.S. in Denali Phase 3 Trial of NCX 470
25 Julio 2024 - 12:30AM
Press Release |
Nicox Announces Recruitment of Last Patient in U.S. in Denali Phase
3 Trial of NCX 470 |
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Recruitment continues in China, on track for topline
results in H2 2025
- NCX 470
demonstrated robust efficacy and safety in topline results from
first Phase 3 trial, Mont Blanc
July 25, 2024 – release at 7:30 am CET Sophia
Antipolis, FranceNicox SA (Euronext Paris:
FR0013018124, ALCOX), an international ophthalmology company, today
announced the recruitment and randomization of the last patient in
the U.S. in its Denali Phase 3 trial of NCX 470.The Denali trial is
evaluating NCX 470 safety and efficacy in patients with open-angle
glaucoma or ocular hypertension and topline results continue to be
expected in H2 2025, based on this completion of recruitment of
patients in the U.S. and continuing good progress of the trial in
China, where recruitment of patients is still ongoing.
More than 95% of the total target number of patients have been
randomized in this trial so far.“I would like to thank our
patients, the clinical sites, our internal team and our investors
for their efforts and support in enabling us to reach this
important milestone, the completion of U.S. recruitment in the
Denali trial. We will remain fully focused on NCX 470 and on
continuing recruitment of patients in China to complete Denali as
we move towards expected topline results in H2 2025.” said
Doug Hubatsch, Chief Scientific Officer of Nicox.
The Denali trial is evaluating the intraocular pressure (IOP)
lowering efficacy of once-daily dosed NCX 470 ophthalmic solution
0.1% compared to latanoprost ophthalmic solution 0.005% in patients
with open-angle glaucoma or ocular hypertension. It is a
multi-country (U.S. and China) clinical trial financed equally by
Nicox and Ocumension, Nicox’s exclusive licensee for China, Korea
and Southeast Asia. The Denali trial, together with the Mont Blanc
trial, was designed to fulfill the regulatory requirements to
support New Drug Application (NDA) submissions of NCX 470 in the
U.S. and China. The U.S. NDA for NCX 470 is expected to
be submitted in H1 2026.Topline results from the first Phase 3
trial, Mont Blanc, showed the IOP-lowering effect from baseline was
8.0 to 9.7 mmHg for NCX 470 vs. 7.1 to 9.4 mmHg for latanoprost.
Statistical non-inferiority was met vs. latanoprost in the primary
efficacy analysis and 4 out of 6 timepoints additionally
demonstrated superiority; the trial therefore met the efficacy
requirements for approval in the U.S. NCX 470 was well tolerated
and discontinuation rates were low. The results of the Mont Blanc
trial have been published in the prestigious American Journal of
Ophthalmology, and numerous post hoc analyses have been presented.
Full details of all presentations and publications can be found at
nicox.com/pipeline-markets-and-science/#publications. |
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
(bimatoprost grenod), 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
www.nicox.com |
Analyst coverage |
H.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 reports. |
Contacts |
|
NicoxGavin SpencerChief Executive OfficerT +33
(0)4 97 24 53 00communications@nicox.com |
Media / Investors Sophie Baumont Cohesion Bureau
+33 6 27 74 74 49 sophie.baumont@cohesionbureau.com |
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.Risks factors which are likely to have a material effect
on Nicox’s business are presented in section 3 of the “Rapport
Annuel 2023” which is available on Nicox’s website
(www.nicox.com).Finally, this press release may be drafted in the
French and English languages. If both versions are interpreted
differently, the French language version shall prevail. |
Nicox S.A.Sundesk Sophia Antipolis, Bâtiment C,
Emerald Square, Rue Evariste Galois, 06410 Biot, FranceT +33 (0)4
97 24 53 00 |
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