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.

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.

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

Risks factors which are likely to have a material effect on Nicox’s business are presented in the 3^rd 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 4^th chapter of the half yearly financial report as of June 30, 2020, which is also available on Nicox’s website.