Nicox Presented NCX 470 Phase 3 Mont Blanc Adaptive Design Data and Additional Subset Analysis Showing Superiority over Latanoprost at the World Glaucoma Congress
July 03 2023 - 1:30AM
Nicox Presented NCX 470 Phase 3 Mont Blanc Adaptive Design Data and
Additional Subset Analysis Showing Superiority over Latanoprost at
the World Glaucoma Congress
Press Release |
Nicox Presented NCX 470 Phase 3 Mont Blanc Adaptive Design Data and
Additional Subset Analysis Showing Superiority over Latanoprost at
the World Glaucoma Congress |
- NCX 470
0.1% showed up to 1.73mmHg greater mean
diurnal intraocular pressure
(IOP) reduction
from baseline than latanoprost in the adaptive
dose selection period of the Phase 3
Mont Blanc trial
- NCX 470
demonstrated a statistically greater proportion of subjects with 10
mmHg or more IOP reduction compared to latanoprost
in the Mont Blanc trial
July 3, 2023 – release at 7:30 am CET Sophia Antipolis,
FranceNicox SA (Euronext Growth Paris:
FR0013018124, ALCOX), an international ophthalmology company, today
announced that additional data on NCX 470 have been presented at
the 10th World Glaucoma Congress (WGC) being held from June 28 to
July 1, 2023 in Rome, Italy.“The large volume of data generated in
the Mont Blanc Phase 3 trial on NCX 470 has provided us with the
opportunity to look in detail at patient subgroups to further
evaluate where NCX 470 has the greatest effect, some of which we
are reporting here. Our first poster at the World Glaucoma Congress
presents the adaptive dose selection data, justifying the choice of
the 0.1% NCX 470 dose for the rest of the trial. We have also
looked across the whole trial and report is that more patients
achieve a reduction of IOP of 10mmHg or more when on NCX 470 than
those on latanoprost. We look forward to reporting other data at
conferences and in planned publications.” said Doug
Hubatsch, Chief Scientific Officer of NicoxPoster
Title: NCX 470, a Nitric Oxide Donating Bimatoprost Compared with
Latanoprost - Adaptive Design Period Results from the Phase 3 Mont
Blanc Clinical Trial A dose finding Phase 2 trial
(Dolomites) tested NCX 470 at several concentrations and the
results suggested that the highest studied dose might still be
below the top of the dose response curve. To test this a
concentration of 0.065% and 0.1% were included in an adaptive dose
selection period of the Phase 3 Mont Blanc trial, which compared
the safety and efficacy of NCX 470 ophthalmic solution vs.
latanoprost ophthalmic solution in adult subjects with open-angle
glaucoma or ocular hypertension. At the Week 2 timepoint, NCX 470
0.065% demonstrated 1.37 mmHg greater mean diurnal IOP reduction
from baseline than latanoprost and NCX 0.1% demonstrated 1.73 mmHg
greater mean diurnal IOP reduction from baseline than latanoprost.
The adaptive dose selection period was used in place of additional
dose ranging studies to select the 0.1% concentration of NCX 470
for the duration of the 3-month Phase 3 Mont Blanc clinical trial
as well as the second Phase 3 trial, Denali. Poster Title:
NCX 470, a Nitric Oxide Donating Bimatoprost versus Latanoprost has
Greater Proportion of Subjects Achieving
≥10 mmHg IOP Decrease in Phase 3
Trial NCX 470 met the primary efficacy endpoint of
non-inferiority to latanoprost at all 9 of 9 timepoints measured in
the Mont Blanc trial. Furthermore, NCX 470 demonstrated a
statistically greater proportion of subjects with 10 mmHg or more
IOP reduction compared to latanoprost at Week 2, Week 6, and Month
3 ranging from 69% to 46% in the NCX 470 group compared to 60% to
34% in the latanoprost group. NCX 470 was safe and well
tolerated.Poster Title: Effects of NCX 470, a Nitric Oxide
(NO)-Donating Bimatoprost, in in vitro
3D-Human Trabecular Meshwork (TM) / Schlemm's Canal (SC)
Tissue ModelBioengineered 3D-human TM/SC (3D-HTM/HSCTM)
constructs and Cynomolgus monkeys were used to provide insights on
the cellular and molecular mechanism/s accounting for NCX
470-mediated intraocular pressure (IOP)-lowering activity. NCX 470
significantly improved outflow facility in 3D-HTM/HSCTM.
Furthermore, unlike most IOP-lowering agents, a clinically
effective dose (0.1% ophthalmic solution) of NCX 470 affected both
conventional and uveoscleral pathways to increase aqueous humor
drainage from monkey eyes. NCX 470 dual-acting modality (NO and
prostaglandin analog) explains the robust reduction of IOP exerted
by this drug in patients with open-angle glaucoma or ocular
hypertension.About NCX 470NCX 470 is a novel
NO-donating bimatoprost eye drop currently in Phase 3 clinical
development for the lowering of IOP in patients with open-angle
glaucoma or ocular hypertension. The first Phase 3 trial, Mont
Blanc, a randomized, double-masked, multi-center, parallel group
trial that was conducted in the U.S., compared NCX 470 (0.1%) to
latanoprost (0.005%) was completed in October 2022. The second
Phase 3 trial, Denali, similarly designed to the Mont Blanc trial,
and which includes a long-term safety extension, is
ongoing.Update on planned Phase 3b trials on NCX
470The timing of the planned Phase 3b trials investigating
the dual mechanism of action (nitric oxide and prostaglandin
analog) in IOP lowering and potential retinal benefits of NCX 470
is currently being assessed and we will provide an update on these
in the Q2 Press Release in mid-July. |
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 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.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 section 2.7 of the ‘Rapport
Annuel 2022’ which is 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 abstracts presented at WGC2023_20230703_F1
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