Nicox Announces the Publication in Leading Scientific Journal of Pre-Clinical Efficacy Results on a New Class of Non-PGA NO-donating IOP-Lowering Compounds

Press Release
Nicox Announces the Publication in Leading Scientific Journal of Pre-Clinical Efficacy Results on a New Class of Non-PGA NO-donating IOP-Lowering Compounds
New class works solely through nitric oxide (NO)-mediated activity Equivalent intraocular pressure (IOP) lowering and faster onset of activity demonstrated vs. the prostaglandin analog (PGA) travoprost February 23, 2021 – release at 7:30 am CET Sophia Antipolis, France Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced the publication of pre-clinical intraocular pressure (IOP)-lowering results on a new class of non-prostaglandin analog (PGA), nitric oxide (NO)-donating compounds, in the Journal of Ocular Pharmacology and Therapeutics1.  Increased IOP is one of the principal risk factors of open-angle glaucoma.  The NO-mediated IOP-lowering effect in this new class of compounds is enhanced by concomitant action of phosphodiesterase type-5 (PDE5) inhibition within the same molecule. Michele Garufi, Chairman and CEO of Nicox, said “This new class of compounds, in which we optimized and enhanced the activity of nitric oxide, has been developed using the years of expertise and research in this area within Nicox.  We have shown with VYZULTA and our promising Phase 3 product candidate, NCX 470, that nitric oxide can bring additional efficacy on top of a prostaglandin analog.  This new class of compounds enhance the nitric oxide-mediated intraocular pressure lowering effect with the concomitant action of phosphodiesterase type-5 inhibition.  We identified product candidates in this class which could potentially be used as monotherapy, or in combination with prostaglandin analogs or other intraocular pressure lowering agents, to add efficacy to existing therapies.” The published data on NCX 1741, an analog of Nicox’s development candidate NCX 1728, compared its IOP lowering effect to that of travoprost in a non-human primate model of ocular hypertension.  This publication reports that NCX 1741 reduced IOP to a similar extent to travoprost, with faster onset of activity.  Travoprost is a prostaglandin analog, a class of molecules which are considered standard of care for IOP lowering in humans. NCX 1728 is the first in this new class of compounds to be selected for development (See Press Release of October 23, 2020).  Nicox will conduct a full characterization of the ophthalmic formulations of NCX 1728 prior to initiating non-clinical testing required for filing an IND application.  Nicox owns all exclusive worldwide rights to NCX 1728 and NCX 1741. The publication can be found at https://pubmed.ncbi.nlm.nih.gov/33595367/. NO-mediated IOP lowering agents It has been established that NO plays a key role in the regulation of IOP.  An NO-donating moiety can be linked to other pharmaceutical agents to improve IOP-lowering efficacy, as is the case with our lead clinical development candidate NCX 470, a novel NO-donating prostaglandin analog, and our commercialized product with the same mechanism of action, VYZULTA® (latanoprostene bunod ophthalmic solution), 0.024%.  VYZULTA®, indicated for the reduction of IOP in patients with open-angle glaucoma or ocular hypertension, is exclusively licensed worldwide to our partner Bausch + Lomb, who is commercializing it in the U.S., Canada, Argentina and Mexico.  The effect of NO on IOP lowering may be further increased and/or prolonged by PDE5 inhibitors, which inhibit the degradation of cyclic guanosine monophosphate (cGMP), a key intracellular messenger that is produced as a result of stimulation by NO.
About Nicox
Nicox S.A. 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 prostaglandin analog, for lowering intraocular pressure in patients with glaucoma.  The company is also developing NCX 4251, a proprietary formulation of fluticasone, for acute exacerbations of blepharitis.  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, in the U.S. and Ocumension Therapeutics in the Chinese and in the majority of South East Asian markets.  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. For more information on Nicox, its products or pipeline, please visit: www.nicox.com.
Analyst coverage
Bryan, Garnier & Co               Victor Floc’h          Paris, France Cantor Fitzgerald                    Louise Chen          New York, U.S. Edison Investment Research Pooya Hemami      London, UK H.C. Wainwright & Co            Yi Chen                  New York, U.S. Kepler Cheuvreux                   Damien Choplain 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 communications@nicox.com
Investors & Media United States & Europe LifeSci Advisors, LLC Mary-Ann Chang T +44 7483 284 853 mchang@lifesciadvisors.com	Media France LifeSci Advisors, LLC Sophie Baumont M +33 (0)6 27 74 74 49 sophie@lifesciadvisors.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 the 3rd chapter of the ‘Document d’enregistrement universel, rapport financier annuel et rapport de gestion 2019’ filed with the French Autorité des Marchés Financiers (AMF) on March 6, 2020 which are available on Nicox’s website (www.nicox.com) and (ii) as restated in the 4th chapter of the half yearly financial report as of June 30, 2020, which is also available on Nicox’s website.
Nicox S.A. Drakkar 2 Bât 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

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¹ Bastia et al, Journal of Ocular Pharmacology and Therapeutics, 2021. doi: 10.1089/jop.2020.0126. Epub ahead of print. PMID: 33595367.

 

 

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• EN_NCX1741 JOPT PR_20210223_F