Nicox’s Announces Publication of New Nonclinical Data Demonstrating More Effective Intraocular Pressure Lowering of NCX 470 compared to Lumigan

Nicox’s Announces Publication of New Nonclinical Data Demonstrating More Effective Intraocular Pressure Lowering of NCX 470 compared to Lumigan




Nicox’s Announces Publication of New Nonclinical Data Demonstrating More Effective Intraocular Pressure Lowering of NCX 470 compared to Lumigan

Press Release
Nicox’s Announces Publication of New Nonclinical Data Demonstrating More Effective Intraocular Pressure Lowering of NCX 470 compared to Lumigan
December 14, 2023 – release at 7:30 am CET
Sophia Antipolis, France

Nicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced that new nonclinical data on NCX 470 (0.1%) demonstrating greater intraocular pressure (IOP) lowering than Lumigan® (bimatoprost ophthalmic solution, 0.01%) upon both single and repeated (5-day) dosing in an in vivo nonclinical model has been published in the peer-reviewed Journal of Ocular Pharmacology and Therapeutics. The publication also includes outflow data on NCX 470 in a different in vivo non clinical model and on NCX 470 compared to equimolar bimatoprost in in vitro human trabecular meshwork/Schlemm’s canal constructs suggesting that NCX 470-mediated increase in outflow facility and uveoscleral outflow accounts for the robust IOP reduction exerted by this compound.

The publication “NCX 470 Reduces Intraocular Pressure More Effectively Than Lumigan in Dogs and Enhances Conventional and Uveoscleral Outflow in Non-Human Primates and Human Trabecular Meshwork/Schlemm’s Canal Constructs” by Galli et al. is available by clicking here.

NCX 470, a novel nitric oxide (NO)-donating bimatoprost eyedrop, is in Phase 3 clinical development for the lowering of IOP in patients with open angle glaucoma or ocular hypertension. NCX 470 is designed to release both bimatoprost and NO into the eye to lower IOP by two pathways. Lumigan, marketed by Allergan, Inc., is the leading branded product by sales 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.

IOP Lowering Study

IOP lowering was measured in ocular normotensive beagle dogs following either single or repeat once-daily morning dosing over 5 consecutive days, in an open-label crossover design, of either NCX 470 (0.1%), Lumigan® (bimatoprost ophthalmic solution, 0.01%) or vehicle. After single-dosing, NCX 470 demonstrated greater IOP reduction than Lumigan at most timepoints tested up to 24 hours post-dosing, with the greatest difference seen at 5 hours.   In the repeat dosing study, the effects of both NCX 470 and Lumigan were generally stable throughout the period of the study, with NCX 470 showing consistently greater IOP reduction than Lumigan® at all timepoints tested.

Outflow Study

Aqueous humor dynamics were studied in ocular normotensive non-human primates treated in a crossover design with either NCX 470 or vehicle over 4 days. Measurements were taken on the fourth day and demonstrated that NCX 470 increased both outflow facility and uveoscleral outflow compared to vehicle. Aqueous humor outflow was also investigated in human trabecular meshwork/Schlemm’s canal constructs treated with equimolar NCX 470 or bimatoprost, or vehicle. Outflow facility was increased by both NCX 470 and bimatoprost compared to vehicle, with NCX 470 having a greater effect than bimatoprost. This data has been previously presented at the 2023 World Glaucoma Congress.

Nicox Corporate Status Update

The 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 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, France
Edison Investment Research        Pooya Hemami        London, UK
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  

Nicox
Gavin Spencer
Executive Vice President, Chief Business Officer
& Head of Corporate Development
T +33 (0)4 97 24 53 00
communications@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 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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