A Phase 1 Study to Assess the Pharmacokinetics of Nitrates and Gamma-Hydroxybutyric Acid (GHB) After Oral Administration of Therapeutic and Supratherapeutic Doses of Naproxcinod in Healthy Male Subjects

This study will be performed in 2 parts conducted in parallel:
Part 1 (conducted on 16 healthy subjects): Administration of naproxcinod 750 mg or naproxen 500 mg twice a day (bid) during 7 days The main aim of this study part will be to assess the pharmacokinetic profile (i.e. the absorption, the distribution, the metabolism and the elimination of the drug after its administration) of nitrates (metabolite of naproxcinod) present in plasma, saliva and urine after oral administration of naproxcinod 750 mg bid for 7 days or naproxen 500 mg bid for 7 days as a reference.
Part 2 (conducted on 8 healthy subjects): Administration of a single dose of naproxcinod 3000 mg. The main aim of this study part will be to assess the pharmacokinetic profile (i.e. the absorption, the distribution, the metabolism and the elimination of the drug after its administration) of Gamma-Hydroxybutyric Acid (GHB), a compound resulting from the transformation of the naproxcinod, after oral administration of a single supratherapeutic dose of 3000 mg.

Start Date01 Jan 2010

Sponsor / Collaborator

Nicox SA

NCT00909519

/ CompletedPhase 1

A Phase 1, Single-Center, Randomized, Parallel-group, Placebo- and Naproxen- Controlled, Double-blind Study to Evaluate the Effect of Naproxcinod 750 mg Bid Administered for 8 Days on the Renal Hemodynamics, Natriuretic and Renin Responses to a Single Bolus IV Dose of Furosemide 40 mg in Male Healthy Normotensive Volunteers

This phase 1 study is an 8-day treatment period, randomized, controlled, double-blind, 3 parallel-groups, monocentric study. The primary objective is to evaluate the effect of naproxcinod on the renal function when co-administered with furosemide in comparison to naproxen and placebo.

Start Date01 Jan 2009

Sponsor / Collaborator

Nicox SA

NCT00674856

/ CompletedPhase 1

A Phase 1 Repeated Dose Open Label Study to Investigate the Pharmacokinetics and Safety of Naproxcinod 750mg Bid Administered to Patients With Impaired Renal Function Compared to Matching Healthy Subjects

To study the pharmacokinetics and safety of naproxcinod in patients with impaired renal function

Start Date01 May 2008

Sponsor / Collaborator

Nicox SA

100 Clinical Results associated with Naproxcinod

100 Translational Medicine associated with Naproxcinod

100 Patents (Medical) associated with Naproxcinod

Literatures (Medical) associated with Naproxcinod

01 Dec 2024·CHEMOMETRICS AND INTELLIGENT LABORATORY SYSTEMS

Quantitative structure properties relationship (QSPR) analysis for physicochemical properties of nonsteroidal anti-inflammatory drugs (NSAIDs) usingVe degree-based reducible topological indices

Author: Faisal, Muhammad ; Rauf, Abdul ; Nazir, Arif ; Aslam, Adnan ; Abdalla, Manal Elzain Mohamed ; Fan, Rong

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) are a class of medications that are used for different therapeutic uses.They effectively alleviate pain, reduce inflammation, and manage fever.These drugs are available in various forms.NSAIDs are prescribed by healthcare professionals to address a wide range of symptoms, from headaches and dental pain to conditions like arthritis and muscle stiffness.In this work, we use ve-degree-based reducible topol. descriptors in quant. structure-property relationship (QSPR) anal. to estimate the physicochem. properties of NSAIDs.In the first step, we have developed a MAPLE-based code to compute the reducible ve-degree-based topol. descriptors of NSAIDs.Then, a linear regression model was used to estimate four physicochem. properties of seventy NSAIDs.It has been observed that two physicochem. properties, namely Mol. Weight and Complexity show a very strong correlation with the reducible ve-degree-based topol. descriptors.For both cases, the value of correlation coefficient is greater than 0.9.Finally, quadratic and cubic regression models were constructed, and a comparative anal. with these models is presented.These results may help enhance the understanding of NSAIDs medication structures and aid in predicting their pharmacol. activity.

01 Mar 2024·Osteoarthritis and cartilage open

Does sex affect the efficacy of systemic pharmacological treatments of pain in knee osteoarthritis? A systematic review

Review

Author: Schnitzer, Thomas J ; Bagherzadeh, Leila ; Wafford, Q Eileen ; Espinosa-Salas, Santiago ; Witte, Graeme

Objective:

To determine whether sex influences the analgesic efficacy of systemic pharmacological treatment in patients with knee osteoarthritis.

Design:

A systematic review, guided by Cochrane methods, sourced studies from Medline, Cochrane Library, Embase, and CINAHL Plus with Full Text as of October 10, 2022. Eligible studies were double-blind RCTs evaluating systemic pharmacological treatments for knee osteoarthritis in adults, with minimum 30-day treatment duration, reporting sex-specific results or mentioning sex subgroup analysis for analgesic efficacy. The risk of bias was assessed using the Cochrane Risk of Bias tool version 2 (RoB 2).

Results:

9 studies (5201 participants) met inclusion criteria, analyzing drugs including duloxetine, etoricoxib, tapentadol, naproxcinod, lutikizumab, and rofecoxib. Only one study reported sex-specific results. Review findings suggested no significant sex-based differences in treatment efficacy, however, data were limited due to a lack of sex-specific reporting or inclusion of sex in subgroup analyses.

Conclusions:

Current evidence does not support the existence of sex differences in the analgesic efficacy of systemic knee osteoarthritis treatments. However, this conclusion is substantially limited by the paucity of sex-specific reporting of results or subgroup analyses in most primary studies, emphasizing the need for future research to report on sex-stratified data to allow for comprehensive, personalized treatment strategies.

31 Aug 2021·Bladder Cancer

Efficacy of EGFR Inhibitors and NSAIDs Against Basal Bladder Cancers in a Rat Model: Daily vs. Weekly Dosing, Combining EGFR Inhibitors with Naproxen, and Effects on RNA Expression

Article

Author: Amit Kumar ; Clinton J. Grubbs ; Ronald A. Lubet ; Altaf Mohammed ; M. Margaret Juliana ; Jennifer T. Fox ; Ming You

BACKGROUND::

There are few effective treatments specifically aimed at basal bladder cancer.

OBJECTIVE::

Female F344 rats administered N-butyl-N-(4-hydroxybutyl)-nitrosamine (OH-BBN) develop large invasive bladder cancers. We determined the efficacy of daily vs weekly dosing of EGFR inhibitors, determined the efficacy of naproxen combined with an EGFR inhibitor, and performed RNA analysis of bladder tumors treated for 5 days with EGFR inhibitors or NO-naproxen to identify pharmacodynamic biomarkers.

METHODS::

Erlotinib (6 mg/Kg BW daily or 21 or 42 mg/Kg BW weekly), lapatinib (25 or 75 mg/Kg BW daily or 263 or 525 mg/Kg BW weekly) and/or naproxen (30 mg/Kg BW daily) were administered to OH-BBN-treated rats beginning 2–12 weeks post OH-BBN. Rats were sacrificed 28 weeks after the final OH-BBN treatment to determine the effects of the EGFR inhibitors + naproxen on bladder weights and tumor development. In a separate study, rats were treated with OH-BBN. When palpable tumors developed, rats were treated with erlotinib, lapatinib, gefitinib, or the NSAID NO-naproxen for 5 days. RNA analysis was performed on the tumors.

RESULTS::

Daily or weekly dosing of erlotinib or lapatinib and daily dosing of naproxen reduced large tumor formation up to 70%, while combining daily lapatinib and naproxen reduced tumors 100%. RNA Analysis: All EGFR inhibitors strongly reduced cell proliferation and chromosome replication pathways, while NO-naproxen altered the G protein receptor, oxygen homeostasis and immune function pathways.

CONCLUSIONS::

While daily and weekly dosing with EGFR inhibitors and naproxen were effective, combining lapatinib and naproxen yielded no tumors. This might encourage its clinical use in an adjuvant setting with superficial basal tumors, and perhaps even in a more advanced setting. Furthermore, RNA analysis identified specific pathways that might be potential pharmacodynamic biomarkers in clinical trials.

News (Medical) associated with Naproxcinod

27 Sep 2021

·www.biospace.com

Nicox First Half 2021 Financial Results and Business Update

Press Release Nicox First Half 2021 Financial Results and Business Update H1 2021 net revenue1 of €1.3 million and cash position of €36.5 million NCX 470 NDA submission remains on track September 27, 2021 – release at 7:30 am CET Sophia Antipolis, France Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today reported the financial results for Nicox SA and its subsidiaries (the “Nicox Group”) for the six months ending June 30, 2021 and provided an update on recent events as well as progress on key programs. First Half 2021 Financial Highlights Net revenue1 for the first half of 2021 was €1.3 million (including €1.2 million in royalty revenue) versus €2.4 million (including €1.4 million in royalty revenue) for the first half of 2020. Operating expenses for the first half of 2021 were €13.3 million compared to €10.2 million for the first half of 2020. The Nicox Group recorded a net loss of €11.7 million for the six months ended June 30, 2021, compared to a net loss of €14.6 million for the same period in 2020. As of June 30, 2021, the Nicox Group had cash and cash equivalents of €36.5 million, as compared with €42.0 million at March 31, 2021 and €47.2 million at December 31, 2020. The Company is financed for at least 12 months, based on the development of NCX 470 alone. As of June 30, 2021, the Nicox Group had financial debt of €18.0 million consisting of €16.0 million in the form of a bond financing agreement with Kreos Capital signed in January 2019 and a €2 million credit agreement guaranteed by the French State and granted in August 2020 in the context of the COVID-19 pandemic. Details of the bond financing agreement can be found in the Press Release of January 29, 2021. Recent Events The Mississippi Phase 2b clinical trial of NCX 4251 ophthalmic suspension 0.1%, evaluated against placebo, while not meeting the pre-defined blepharitis primary endpoint, demonstrated statistically significant results on blepharitis signs and symptoms when measured as change from baseline. NCX 4251 was found to be safe and well-tolerated over 14 days’ treatment, with no serious adverse events (see Press Release of September 23, 2021). VYZULTA® (latanoprostene bunod ophthalmic solution), 0.024%, recently received regulatory approval in Brazil, Jordan and Singapore. Further approvals and launches of VYZULTA will now be reported by our global partner Bausch + Lomb on a quarterly basis. Dr. José Boyer has retired as Interim Head of R&D, although he will continue to advise the Company as a consultant. We would like to thank him for his commitment and contribution to Nicox. Fera’s resubmitted application for Orphan Drug Designation (ODD) for naproxcinod in sickle-cell disease has been refused by the U.S. Food and Drug Administration (FDA), and Fera is currently seeking to discuss the next steps with the FDA. Fera continues to review other undisclosed therapeutic indications for naproxcinod. Key Programs Updates NCX 470: The New Drug Application submission timing to the U.S. FDA remains in line with our expectations, driven by the end of 2023 date for results from the ongoing Denali Phase 3 clinical trial. In the first Phase 3 clinical trial, Mont Blanc, 494 out of 670 patients (74%) had been randomized as of September 20, and 398 of those patients have completed the 3-month efficacy evaluation. Given recruitment continues to be impacted by COVID-19, we are prudently moving the expectation for Mont Blanc trial top-line results to Q1 2023 (previously Q2 2022). The Phase 3 program, evaluating NCX 470 for lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension, is expected to support NDA submissions in the U.S. and China, and will also provide data for countries accepting the same package for approval. NCX 4251: Following the results of the Phase 2b Mississippi trial, the Company plans to meet with the U.S. FDA in early 2022 to discuss next steps in the development of this innovative product candidate for blepharitis. ZERVIATETMin China: A Phase 3 clinical trial intended to support an application for regulatory approval in China, conducted and financed by our partner Ocumension, is ongoing. Only figures at December 31, 2020 are audited, all other figures of this press release are non-audited. Notes Net revenue consists of revenue from collaborations less royalty payments which we refer to as net profit from collaborations in the condensed consolidated statements of profit or loss for the six-month period ended June 30, 2021. 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: . 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 Sandya von der Weid T +41 78 680 05 38 svonderweid@lifesciadvisors.com Media France LifeSci Advisors, LLC Sophie Baumont T +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 2020’ filed with the French Autorité des Marchés Financiers (AMF) on March 1, 2021 which are 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 nicox sa Interim Consolidated statement of Comprehensive Income 6 Months period ending June 30, 2021 2020 (in thousands of € except for per share data) Revenues from collaborations 2,043 3,271 Royalty payments (721) (891) Net Profit from collaborations 1,322 2,380 Research and development expenditures (10,000) (6,533) Administrative expenses (3,263) (3,496) Other income 466 840 Other expenses (90) (174) Operating loss before amortization of intangible assets (11,565) (6,983) Amortization of intangible assets (587) (645) Operating loss (12,152) (7,628) Finance income 1,451 1,213 Finance expense (1,036) (8,166)(1) Net financial income/(expense) 415 (6,953) Loss before tax (11,737) (14,581) Income tax (expense) / benefit 24 (26) Net loss for the period (11,713) (14,607) (1) Included €6.1 million of expenses without cash impact related to the impairment of VISUfarma assets sold in July 2020. nicox sa Interim consolidated statement of financial position As of June 30, 2021 As of Dec. 31, 2020 (in thousands of €) ASSETS Non-current assets Goodwill 24,433 23,663 Intangible assets 66,356 64,848 Property, plant and equipment 1,029 1,166 Non-current financial assets 69 68 Total non-current assets 91,887 89,745 Current assets Clients 1,283 1,723 Government grants receivables 1,130 736 Other current assets 317 237 Prepayments 2,209 2,630 Cash and cash equivalents 36,528 47,195 Total current assets 41,467 52,521 TOTAL ASSETS 133,354 142,266 EQUITY AND LIABILITIES Shareholder’s equity Issued capital 37,112 37,030 Share premium 528,513 528,595 Cumulative translation adjustement 4,597 2,959 Treasury shares (873) (605) Accumulated deficit (478,033) (467,169) Total Equity 91,316 100,810 Non-current liabilities Non-current financial liabilities 16,031 13,429 Deferred tax liabilities 12,255 11,868 Non current provisions 819 754 Total non-current liabilities 29,105 26,051 Current liabilities Current financial liabilities 2,917 5,646 Trade payables 3,433 2,422 Deferred income 5,113 5,174 Other current liabilities 1,470 2,163 Total current liabilities 12,933 15,405 TOTAL LIABILITIES AND EQUITY 133,354 142,266 Attachment EN_H1_2021Results PR_20210927_F

CollaborateFinancial StatementOrphan Drug

18 Nov 2010

·www.biospace.com

NicOx SA Presents NCX 6560 Phase 1b Results At AHA

SOPHIA ANTIPOLIS, FRANCE--(Marketwire - November 18, 2010) - Highlighted Links companynewsgroup Home Page NicOx S.A. (NYSE Euronext Paris: COX) today announced that Dr. Jacques Djian, Vice President of Exploratory Development and Translational Medicine at NicOx, recently presented results from the phase 1b first-in-man study for NCX 6560 in an oral session of the American Heart Association (AHA) 2010 Scientific Sessions being held in Chicago, Illinois. NCX 6560 is an innovative nitric oxide (NO)-donating New Molecular Entity (NME) targeting patients with Acute Coronary Syndrome (ACS). The abstract of Dr. Djian's presentation has also been published in a supplement of Circulation1 and is available on the journal's website ( ). The oral presentation of Dr. Djian included further details of the phase 1b study results disclosed in November 2009 (see NicOx press release dated November 13, 2009). In this two-week study, NCX 6560, an NO-donating atorvastatin, appeared safe and well tolerated. A dose-related LDL- cholesterol decrease was observed, with the highest tested dose of NCX 6560 (144 mg) reaching a 57% reduction after two weeks of treatment. No significant increase in liver enzymes was observed, even at the highest dose, which was not different from atorvastatin 40 mg. Interestingly, NCX 6560 48 mg had the same lipid-lowering effects as atorvastatin 40 mg despite a lower exposure to atorvastatin and its active metabolites. NO donation from NCX 6560 is expected to enhance the pleiotropic effects of statins outside of lipid lowering. Preclinical studies have shown that NCX 6560 demonstrated superior anti-thrombotic and anti-inflammatory properties, and greater effects on endothelial function than an equivalent dose of atorvastatin. Preclinical results suggesting promising anti- inflammatory and anti-atherogenic effects were also presented during the AHA 2010 Scientific Sessions2. NicOx is currently seeking partners to advance the clinical development of NCX 6560. 1 Djian JP, Maucci R, Guilmin L, Ferreira T, Pfister P, Abstract 14267: NCX 6560, a Novel Nitric Oxide Donating Atorvastatin With a Promising Safety and Efficacy Profile: A Randomised, Double Blind Placebo and Active Control Study, Circulation 2010, 122, A14267. 2 Momi S, Falcinelli E, Alberti FP, Monopoli A, Miglietta D, Ongini E, Gresele P, Abstract 15758: Anti-Inflammatory and Anti-Atherogenic Activities of NCX 6560, a Nitric Oxide (NO)-Donating Statin, in Hypercholesterolemic Mice, Circulation 2010, 122: A15758. Risks factors which are likely to have a material effect on NicOx's business are presented in the 4th chapter of the " Document de référence, rapport financier annuel et rapport de gestion 2009 " filed with the French Autorité des Marchés Financiers (AMF) on March 5, 2010 and available on NicOx's website ( ) and on the AMF's website ( ). The Company notably draws the investors' attention to the following risk factors: - Risques liés à la dépendance de la Société à l'égard du naproxcinod (Risks related to the Company's dependence on the success of its lead product naproxcinod) - Risques commerciaux et développements cliniques (Clinical developments and commercial risk) - Risques liés aux contraintes réglementaires et à la lenteur des procédures d'approbation (Risks linked to regulatory constraints and slow approval procedures) - Manque de capacités dans les domaines de la vente et du marketing (Lack of sales and marketing capabilities) - Incertitude relative aux prix des médicaments et aux régimes de remboursement, ainsi qu'en matière de réforme des régimes d'assurance maladie (Uncertainty on drug pricing and reimbursement policies and on the reforms of the health insurance systems) NicOx (Bloomberg: COX:FP, Reuters: NCOX.PA) is a pharmaceutical company focused on the research, development and future commercialization of drug candidates. NicOx is applying its proprietary nitric oxide-donating R&D platform to develop an internal portfolio of New Molecular Entities (NME) for the potential treatment of inflammatory, cardio-metabolic and ophthalmological diseases. NicOx's lead investigational compound is naproxcinod, an NME and a first- in-class CINOD (Cyclooxygenase-Inhibiting Nitric Oxide-Donating) anti- inflammatory drug candidate developed for the relief of the signs and symptoms of osteoarthritis (OA). In July 2010, the Food and Drug Administration (FDA) provided a Complete Response Letter to the New Drug Application (NDA) for naproxcinod stating that it does not approve the naproxcinod application. The naproxcinod Marketing Authorization Application (MAA) submitted by NicOx in December 2009 is currently under review by the European Medicines Agency (EMA). In addition to naproxcinod, NicOx's pipeline includes several nitric oxide- donating NMEs, which are in development internally and with partners, including Merck (known as MSD outside the United States and Canada) and Bausch + Lomb, for the treatment of select cardiovascular indications, eye diseases and dermatological diseases. NicOx S.A. is headquartered in France and is listed on Euronext Paris (Compartment B: Mid Caps). This press release contains certain forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated in the forward-looking statements. For a discussion of risks and uncertainties which could cause actual results, financial condition, performance or achievements of NicOx S.A. to differ from those contained in the forward-looking statements, please refer to the Risk Factors ("Facteurs de Risque") section of the Document de Reference filed with the AMF, which is available on the AMF website ( ) or on NicOx S.A.'s website ( ). CONTACTS NicOx Gavin Spencer - Vice President Business Development Tel +33 (0)4 97 24 53 00 - communications@nicox.com Media Relations Financial Dynamics Europe Guillaume Granier (France) - Tel: +33 (0)1 47 03 68 10 - guillaume.granier@fd.com Stéphanie Bia (France) - Tel: +33 (0)1 47 03 68 10 - stephanie.bia@fd.com Jonathan Birt (UK) - Tel +44 (0)20 7269 7205 - jonathan.birt@fd.com United States Robert Stanislaro - Tel +1 212 850 5657 - robert.stanislaro@fd.com Irma Gomez-Dib - Tel +1 212 850 5761 - irma.gomez-dib@fd.com NicOx S.A., Les Taissounières - Bât HB4 - 1681 route des Dolines - BP313, 06906 Sophia Antipolis cedex, France. Tel. +33 (0)4 97 24 53 00 - Fax +33 (0)4 97 24 53 99 This information is provided by HUGIN

AHA

22 Dec 2009

·www.biospace.com

NicOx SA Submits Naproxcinod MAA to the FDA

SOPHIA ANTIPOLIS, FRANCE--(Marketwire - December 22, 2009) - Highlighted Links companynewsgroup Home Page NicOx S.A. (NYSE Euronext Paris: COX) today announced that a Marketing Authorization Application (MAA) for naproxcinod has been submitted to the European Medicines Agency (EMEA) through the centralized procedure, seeking approval for an indication for the relief of the signs and symptoms of osteoarthritis (OA). This follows the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) in September that has recently been accepted for filing. Naproxcinod is NicOx's lead investigational compound and the first in a new class of anti-inflammatory agents known as CINODs (Cyclooxygenase-Inhibiting Nitric Oxide Donators). The MAA supported by data from a large program of 34 clinical trials that involved more than 4,000 subjects treated with naproxcinod. The program evaluated the efficacy of naproxcinod in relieving signs and symptoms of osteoarthritis, as well as its safety, with a particular care given to its effect on blood pressure. Philippe Serrano, Vice President Regulatory Affairs at NicOx, commented: "As planned, we have ended 2009 with the regulatory submissions for naproxcinod both in Europe, where we have just submitted an MAA through the centralized procedure, as well as the United States, where the FDA has recently accepted our NDA for filing." Pascal Pfister, Chief Scientific Officer and Head of Research & Development at NicOx, added: "We are proud of all the achievements of our team during these last few years, including the completion of these important milestones on time. We will enter 2010 with confidence and are looking forward to working with the FDA and the EMEA during their review of the naproxcinod data." NicOx (Bloomberg: COX:FP, Reuters: NCOX.PA) is a pharmaceutical company focused on the research, development and future commercialization of drug candidates. NicOx is applying its proprietary nitric oxide-donating R&D platform to develop an internal portfolio of New Chemical Entities (NCEs) for the potential treatment of inflammatory, cardio-metabolic and ophthalmological diseases. NicOx's lead investigational compound is naproxcinod, an NCE and a first-in-class CINOD (Cyclooxygenase-Inhibiting Nitric Oxide-Donating) anti-inflammatory drug candidate for the relief of the signs and symptoms of osteoarthritis. NicOx submitted a New Drug Application (NDA) for naproxcinod to the US Food and Drug Administration (FDA) in September 2009 and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) in December 2009, following the successful completion of three pivotal phase 3 studies. The NDA for naproxcinod was accepted for filing by the FDA in November 2009 and the FDA has set a target date of July 24 2010, for the completion of its review. The FDA and the EMEA will evaluate the data submitted. NicOx does not wish to make any claims in regard to naproxcinod's safety or efficacy prior to its potential approvals. In addition to naproxcinod, NicOx's pipeline includes several nitric oxide-donating NCEs, which are in development internally and with partners, including Merck & Co., Inc., for the treatment of widespread eye diseases, cardiometabolic diseases, hypertension, respiratory disorders and dermatological disease. NicOx S.A. is headquartered in France and is listed on Euronext Paris (Compartment B: Mid Caps). This press release contains certain forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated in the forward-looking statements. For a discussion of risks and uncertainties which could cause actual results, financial condition, performance or achievements of NicOx S.A. to differ from those contained in the forward-looking statements, please refer to the Risk Factors ("Facteurs de Risque") section of the Document de Reference and its update filed with the AMF, which are available on the AMF website ( ) or on NicOx S.A.'s website ( ). CONTACTS: NicOx: Karl Hanks Director of Investor Relations and Corporate Communication Tel +33 (0)4 97 24 53 42 - hanks@nicox.com Media in the United States - FD Robert Stanislaro - Tel +1 212 850 5657 - robert.stanislaro@fd.com Irma Gomez-Dib - Tel +1 212 850 5761 - irma.gomez-dib@fd.com Media in Europe - Citigate Dewe Rogerson David Dible - Tel +44 (0)207 282 2949 - david.dible@citigatedr.co.uk Nina Enegren - Tel +44 (0)207 282 1050 - nina.enegren@citigatedr.co.uk NicOx S.A., Les Taissounières - Bâ centst HB4 - 1681 route des Dolines - BP313, 06906 Sophia Antipolis cedex, France. Tel. +33 (0)4 97 24 53 00 - Fax +33 (0)4 97 24 53 99 This information is provided by HUGIN

First in Class

100 Deals associated with Naproxcinod

External Link

KEGG	Wiki	ATC	Drug Bank
D09568	Naproxcinod	M01AE18	DB06682

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Muscular Dystrophy, Duchenne	NDA/BLA	-	Nicox SA	-
Osteoarthritis, Hip	Phase 3	United States	Nicox SA	01 Jun 2007
Osteoarthritis, Hip	Phase 3	Canada	Nicox SA	01 Jun 2007
Osteoarthritis, Knee	Phase 3	-	Nicox SA	01 Dec 2005
Hypertension, Renal	Phase 1	-	Nicox SA	01 Jan 2009
Essential Hypertension	Phase 1	United States	Nicox SA	01 Mar 2008
Hepatic Insufficiency	Phase 1	United States	Nicox SA	01 Jan 2008
Anemia, Sickle Cell	Preclinical	United States	Fera Pharmaceuticals LLC	-
COVID-19	Preclinical	United States	-	-

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00541489 (Pubmed)	Phase 3	Osteoarthritis, Hip	810	Naproxcinod 750 mg	xsdoosvfqo(iesjoeaztb) = pthwdwlblu ovfzrhahef (ukrcaodyqh ) View more	Positive	01 Dec 2010
				Placebo	xsdoosvfqo(iesjoeaztb) = zmwxolfzpz ovfzrhahef (ukrcaodyqh ) View more
EULAR2010	Phase 3	Osteoarthritis	2,741	Naproxcinod 750 mg	pfdwfockot(qybpwoocvv) = hvhaywzisq qgzyddtpkt (qcrgoncdwj ) View more	-	16 Jun 2010
				Naproxcinod 375 mg	pfdwfockot(qybpwoocvv) = ackabqzudc qgzyddtpkt (qcrgoncdwj ) View more
9D.02 (ESH2010)	Phase 3	-	332	Naproxcinod 375 mg	fquflsdusz(mrkxyvkajp) = zbnijwxxdr gqyvyofmyd (oimmyzrdxx, 2.39)	Positive	01 Jun 2010
				Naproxcinod 750 mg	fquflsdusz(mrkxyvkajp) = bubmdnqhif gqyvyofmyd (oimmyzrdxx, 1.74)
EULAR2009	Phase 1	Osteoarthritis \| Essential Hypertension	118	Naproxcinod 375 mg bid	tmhjkqgnxd(odaprpcwnf) = ocvstlwuik wobmixrxrc (zgpkypxshd )	-	10 Jun 2009
				Naproxen 250 mg bid	tmhjkqgnxd(odaprpcwnf) = tzcdlagrmc wobmixrxrc (zgpkypxshd )
EULAR2008	Phase 3	-	-	Naproxcinod	bdyxhmdslq(hbtymqvxvn) = bjyxpqxjzr ytjjqpqqhz (rzpilovaeo ) View more	-	11 Jun 2008
				Naproxen	bdyxhmdslq(hbtymqvxvn) = paylrvjxmk ytjjqpqqhz (rzpilovaeo )
EULAR2008	Phase 3	Osteoarthritis, Knee	918	Naproxcinod 375 mg bid	nfuuymazqc(ikpzanozjr) = rrpfcssuok bogmelrggu (bxoqohydlk ) View more	-	11 Jun 2008
				Naproxcinod 750 mg bid	nfuuymazqc(ikpzanozjr) = yyzzxefzyb bogmelrggu (bxoqohydlk ) View more
not available (EULAR2004)	Phase 2	Osteoarthritis, Knee	672	AZD3582 125 mg bid	wdvmqdpkit(bqdlrpetfg) = mimjyclcvh ynohoglyye (vceydntwxg )	Positive	09 Jun 2004
				AZD3582 375mg bid	wdvmqdpkit(bqdlrpetfg) = lcunlweakv ynohoglyye (vceydntwxg )

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