{"id":450293,"date":"2021-03-04T01:33:25","date_gmt":"2021-03-04T06:33:25","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=450293"},"modified":"2021-03-04T01:33:25","modified_gmt":"2021-03-04T06:33:25","slug":"nicoxs-ncx-470-receives-approval-by-chinese-authorities-for-local-start-of-denali-phase-3-trial","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/nicoxs-ncx-470-receives-approval-by-chinese-authorities-for-local-start-of-denali-phase-3-trial\/","title":{"rendered":"Nicox\u2019s NCX 470 Receives Approval by Chinese Authorities for Local Start of Denali Phase 3 Trial"},"content":{"rendered":"
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\n Press Release<\/strong>\n <\/td>\n<\/tr>\n
Nicox\u2019s NCX 470 Receives Approval by Chinese Authorities for Local Start of Denali Phase 3 Trial<\/td>\n<\/tr>\n
\u00a0<\/p>\n

March 4, 2021 \u2013 release at 7:30 am CET
Sophia Antipolis, France<\/p>\n

Nicox SA<\/strong> (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that its partner, Ocumension Therapeutics, has received approval from China\u2019s Center for Drug Evaluation of the National Medical Products Administration to conduct the Chinese part of the ongoing NCX 470 Denali Phase 3 clinical trial for the lowering of intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension.<\/p>\n

Nicox\u2019s lead clinical product candidate, NCX 470, is a novel nitric oxide (NO)-donating prostaglandin analog licensed exclusively to Ocumension Therapeutics for the Chinese, Korean and South East Asian markets.<\/p>\n

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Dr. Jos\u00e9 Boyer, Interim Head of R&D <\/strong>at Nicox<\/strong>, said: \u201cThis approval allows us to initiate Chinese patients in the Denali trial on schedule. \u00a0This will pave the way for Nicox and Ocumension to submit New Drug Applications in parallel in the U.S. and China, respectively, and potentially bring NCX 470 to these two important markets in similar timeframes.\u201d<\/em><\/p>\n

\u00a0<\/em><\/p>\n

The Press Release by Ocumension can be found here<\/u><\/a>.<\/p>\n

Denali, the second Phase 3 trial of NCX 470<\/u><\/a><\/strong> for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension, was initiated in the U.S. on November 9, 2020.\u00a0 Denali is a 3-month trial evaluating the safety and efficacy of NCX 470 ophthalmic solution, 0.1% versus latanoprost ophthalmic solution, 0.005% and will also include a long-term safety extension.\u00a0 The trial is financed jointly and in equal parts by Nicox and Ocumension and includes clinical sites in both the U.S. and China, with the majority of the patients to be recruited in the U.S.\u00a0 The Denali trial, together with the ongoing Mont Blanc trial, are designed to fulfill the regulatory requirements for Phase 3 safety and efficacy trials to support New Drug Application (NDA) submissions in the U.S. and China.\u00a0 Top-line results are currently expected in Q4 2022. <\/p>\n

NCX 470 is also being studied in Mont Blanc, a 3-month trial evaluating the safety and efficacy of NCX 470 ophthalmic solution, 0.1%, against latanoprost ophthalmic solution, 0.005%, for lowering of IOP in patients with open-angle glaucoma or ocular hypertension.\u00a0 Top-line results are currently expected in H1 2022.<\/td>\n<\/tr>\n

\n About NCX 470<\/strong>\n <\/td>\n<\/tr>\n
NCX 470 is a novel, potential best-in-class, nitric oxide (NO)-donating prostaglandin analog in development to reduce intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.\u00a0 Glaucoma is a group of ocular diseases in which the optic nerve is injured, leading to peripheral and, ultimately, central visual field loss and it can eventually lead to blindness if not treated.\u00a0 It is frequently linked to abnormally high IOP (~90% of patients) due to blockage or malfunction of the eye\u2019s aqueous humor drainage system in the front of the eye.\u00a0 In 2019, worldwide sales of treatments targeting glaucoma were over $6.0 billion out of a $21.9 billion worldwide market for ophthalmic drugs.\u00a0 <\/p>\n

NCX 470 is designed to release both bimatoprost and NO following instillation into the eye.\u00a0 Bimatoprost, marketed under the brand name LUMIGAN\u00ae by Allergan, Inc., is one of the leading products in the class of prostaglandin analogs, the most widely used class of drugs for IOP-lowering in patients with open-angle glaucoma or ocular hypertension.<\/td>\n<\/tr>\n

\n About Nicox<\/strong>\n <\/td>\n<\/tr>\n
Nicox S.A. is an international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health.\u00a0 Nicox\u2019s lead program in clinical development is NCX 470, a novel nitric oxide-donating prostaglandin analog, for lowering intraocular pressure in patients with glaucoma.\u00a0 The company is also developing NCX 4251, a proprietary formulation of fluticasone, for acute exacerbations of blepharitis.\u00a0 Nicox generates revenue from VYZULTA\u00ae in glaucoma, licensed exclusively worldwide to Bausch + Lomb, and ZERVIATE\u00ae<\/sup> in allergic conjunctivitis, licensed in multiple geographies, including to Eyevance Pharmaceuticals, LLC, in the U.S. and Ocumension Therapeutics in the Chinese and in the majority of South East Asian markets.\u00a0 <\/p>\n

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. <\/p>\n

For more information on Nicox, its products or pipeline, please visit: www.nicox.com<\/u><\/a>.<\/u><\/td>\n<\/tr>\n

\n Analyst coverage<\/strong>\n <\/td>\n<\/tr>\n
\u00a0<\/p>\n

Bryan, Garnier & Co \u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Victor Floc\u2019h\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Paris, France
Cantor Fitzgerald\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Louise Chen\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 New York, U.S.
Edison Investment Research Pooya Hemami\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 London, UK
H.C. Wainwright & Co\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Yi Chen\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 New York, U.S.
Kepler Cheuvreux\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Damien Choplain\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Paris, France<\/p>\n

\u00a0<\/em><\/td>\n

\u00a0<\/td>\n<\/tr>\n
\n 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. \u00a0Nicox disavows any obligation to correct or to update the information contained in analyst reports.<\/em>\n <\/td>\n<\/tr>\n
\n Contacts<\/strong>\n <\/td>\n<\/tr>\n
\n Nicox<\/strong>
\n
Gavin Spencer
Executive Vice President, Chief Business Officer
& Head of Corporate Development\u00a0
T +33 (0)4 97 24 53 00
communications@nicox.com <\/u><\/a><\/td>\n<\/tr>\n
Investors & Media
United States & Europe
LifeSci Advisors, LLC
Mary-Ann Chang
T +44 7483 284 853
mchang@lifesciadvisors.com<\/u><\/a><\/td>\n		Media
France
LifeSci Advisors, LLC
Sophie Baumont
M +33 (0)6 27 74 74 49
sophie@lifesciadvisors.com<\/u><\/a><\/td>\n<\/tr>\n
\n Forward-Looking Statements<\/strong>\n <\/td>\n<\/tr>\n
The information contained in this document may be modified without prior notice.\u00a0 This information includes forward-looking statements. Such forward-looking statements are not guarantees of future performance.\u00a0 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.\u00a0 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.<\/p>\n

Risks factors which are likely to have a material effect on Nicox\u2019s business are presented in the 3rd<\/sup> chapter of the \u2018Document d\u2019enregistrement universel, rapport financier annuel et rapport de gestion 2020<\/em>\u2019 filed with the French Autorit\u00e9 des March\u00e9s Financiers<\/em> (AMF) on March 1, 2021 which are available on Nicox\u2019s website (www.nicox.com<\/u><\/a>).<\/td>\n<\/tr>\n

\n Nicox S.A.<\/strong>
\n
Drakkar 2
B\u00e2t 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<\/td>\n<\/tr>\n<\/table>\n

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\n Attachment<\/strong>\n <\/p>\n