03/05/2019 06:30:00

Nicox Presents First Data on Promising New Class of Nitric Oxide (NO)-Donating Compounds for Glaucoma at the ARVO 2019 Annual Meeting

Press Release

Nicox Presents First Data on Promising New Class of Nitric Oxide (NO)-Donating Compounds for Glaucoma at the ARVO 2019 Annual Meeting

  • Nitric oxide (NO)-donating phosphodiesterase-5 (PDE5) inhibitors constitute new drug class for patients with glaucoma

  • Lead molecule substantially and sustainably lowers intraocular pressure (IOP) in non-human primate model of ocular hypertension

  • Potential for development as adjunctive therapy or in fixed-dose combinations with latanoprost or other prostaglandin analogs (PGAs) for lowering IOP in patients with glaucoma or ocular hypertension

May 3, 2019 – release at 7:30 am CET

Sophia Antipolis, France

 

Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that it has presented the first data from a new drug class designed to lower IOP -  NO-donating PDE5 inhibitors - at a poster presentation during the Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO 2019). The first lead molecule from the NO-donating PDE5 inhibitor program shows a substantial lowering of IOP in a non-human primate model of ocular hypertension.

Michele Garufi, Chairman and Chief Executive Officer of Nicox, said, “Our innovative nitric oxide donating research platform has generated a highly promising new compound to expand our industry-leading glaucoma portfolio. While our first generation NO-donating drug VYZULTA® is marketed by partner Bausch + Lomb, we expect to report Phase 2 top line results for our advanced second generation compound NCX 470 in Q4 of this year.  Moreover, we are aiming to confirm a lead clinical candidate from the NO-donating PDE5 inhibitor program for further development in 2020.”

Nicox is focusing its research activities on combining NO-donation with other complementary mechanisms of action which are not currently utilized in any approved ophthalmic product, including PDE5 inhibition and soluble guanylate cyclase (sGC) stimulation.  Molecules from these classes could be developed either as adjunctive therapies or in fixed-dose combinations with latanoprost or other PGAs for IOP lowering.

New data presented by Nicox at ARVO

  • NCX 1741, a novel NO-donating derivative of the phosphodiesterase-5 inhibitor avanafil, reduces IOP in models of ocular hypertension and glaucoma
  • Concomitant dosing of the NO-donor NCX 667 (1%) and Xalatan® (latanoprost ophthalmic solution 0.005%) results in robust and sustained IOP-lowering in ocular normotensive dogs)
  • Nonclinical development of NCX 470, a novel NO-donating, IOP lowering prostaglandin analog for glaucoma and ocular hypertension 
  • Preclinical Evaluation of NCX 4251, a Novel Steroid Therapy for Blepharitis, Targeted Directly to the Eyelid Margin to Reduce the Potential for IOP Elevations
ARVO 2019 took place from April 28-May 2, 2019 in Vancouver, Canada

About Nicox

Nicox S.A. is an international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health.  By leveraging our proprietary expertise in nitric oxide (NO) donation and other technologies, we are developing an extensive portfolio of novel product candidates that target multiple ophthalmic conditions, including glaucoma.  Our portfolio includes three programs in development including NCX 470 for intraocular pressure lowering, based on our proprietary NO-donating research platform and NCX 4251, a proprietary formulation of the well-established molecule fluticasone, for acute exacerbations of blepharitis.  Our research activities are focused on novel future generation NO-donors including NO-donating phosphodiesterase-5 (PDE5) inhibitors and NO-donating soluble guanylate cyclase (sGC) stimulators (in partnership with Ironwood).  In addition, we have two ophthalmology assets that have been approved by the U.S. Food and Drug Administration (FDA); VYZULTA® (latanoprostene bunod ophthalmic solution), 0.024%, exclusively licensed worldwide to Bausch + Lomb, a Bausch Health Companies Inc. company, and commercialized in the U.S. by Bausch + Lomb since December 2017, as well as ZERVIATE™ (cetirizine ophthalmic solution), 0.24%, exclusively licensed in the U.S. to Eyevance Pharmaceuticals, LLC.  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   Hugo Solvet   Paris, France

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.

Upcoming financial and business conferences

 

May 16  European MidCap Event    Copenhagen, Denmark 

June 2-6  BIO 2019    Philadelphia, U.S.

June 18-19  European MidCap Event  Paris, France

June 19-20  JMP Securities Healthcare Conference  New York, U.S.

June 24-25   HealthTech Investor Day  Paris, France

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

Hans Herklots

T +41 79 598 71 49  

hherklots@lifesciadvisors.com

Media

France

LifeSci Advisors, LLC

Sophie Baumont

M +33 (0)6 27 74 74 49

sophie@lifesciadvisors.com

Disclaimer

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 4th chapter of the ‘Document de référence, rapport financier annuel et rapport de gestion 2018’ filed with the French Autorité des Marchés Financiers (AMF) on March 6, 2019 which are available on Nicox’s website (www.nicox.com).

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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