New Data on Two Nicox’s Assets, NCX 470 and NCX 1728, Presented at ARVO 2023

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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, France

Nicox 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, France
Edison Investment Research        Pooya Hemami        London, UK
H.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  
Nicox
Gavin Spencer
Executive Vice President, Chief Business Officer
& Head of Corporate Development
T +33 (0)4 97 24 53 00
[email protected]
 
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 2
Bât D, 2405 route des Dolines
06560 Valbonne, France
T +33 (0)4 97 24 53 00
F +33 (0)4 97 24 53 99
 

 

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