NCX 470 Phase 2 clinical study initiated in Q3 2018
NCX 4251 on track for U.S. IND filing in Q1 2019 to enable first-in-human Phase 2 clinical study
Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmic company, today reported the financial results for the Nicox Group for the six months ending June 30, 2018 and provided an update on its activities.
Michele Garufi, Chairman and Chief Executive Officer of Nicox, said: “Nicox is entering a new and exciting phase with the initiation of the Phase 2 study for our lead product candidate NCX 470 for IOP reduction in patients with open-angle glaucoma or ocular hypertension, and by strengthening our U.S. presence in our new site in Research Triangle Park in North Carolina. We have assembled the right team to achieve our important near term clinical and corporate milestones and continue delivering on all objectives in line with our growth strategy.”
Key Upcoming Milestones
- Q1 2019: Planned Investigational New Drug (IND) submission to the United States (U.S). Food and Drug Administration (FDA) for NCX 4251 to enable a Phase 2 clinical study in patients with acute exacerbations of blepharitis.
- Q1 2019: Expected delivery of ZERVIATETM (cetirizine ophthalmic solution), 0.24% commercial product to Eyevance Pharmaceuticals LLC, followed by a launch for the spring 2019 allergy season in the U.S.
- H2 2019: Expected top-line data from the NCX 470 Phase 2 study for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
Product and Product Candidates Updates
- A Phase 2 study was initiated in Q3 2018 for Nicox’s product candidate NCX 470, a novel second generation nitric oxide (NO)-donating prostaglandin analog. This multicenter, double-masked, 28-day, parallel group, dose response study aims to evaluate the efficacy and safety of NCX 470 compared to latanoprost 0.005% in adult patients with elevated IOP due to open-angle glaucoma or ocular hypertension. The study is expected to randomize 420 patients in clinical sites across the U.S. The primary endpoint of the study is the mean reduction in diurnal IOP after 4 weeks of treatment, while the overall objective is to identify the appropriate dose of NCX 470 to be advanced into Phase 3 studies. This Phase 2 study was initiated following the submission of an IND application in June 2018, ahead of the previously disclosed target date of the third quarter of 2018. Nicox expects to report top-line data from this Phase 2 study in the second half of 2019.
- Preclinical and formulation development of Nicox’s product candidate NCX 4251, a novel, patented ophthalmic suspension of fluticasone propionate nanocrystals, is continuing on track for the Q1 2019 IND submission to the U.S FDA to enable a Phase 2 study to evaluate the safety and efficacy of NCX 4251 compared to its vehicle in patients with acute exacerbations of blepharitis. An additional and positive pre-IND meeting was held with the U.S. FDA in June 2018, which addressed specific questions on development, including the potential primary endpoints. Based on FDA feedback, we are finalizing the design of the first-in-human Phase 2 study.
- Two molecules from our future generation stand-alone NO-donors that target IOP reduction, NCX 667 and NCX 1660, are currently in formulation development and testing with the Re-Vana EyeLiefTM technology under the research collaboration agreement signed in October 2017. Depending on the release profile of these molecules with this technology in preclinical animal models of ocular pharmacokinetics, they may be advanced into further development and/or we may decide to test other molecules in the same technology.
- Our research activities continue both in our research collaboration agreement with Ironwood, announced in June 2018, which is focused on combining Ironwood’s expertise in soluble guanylate cyclase with our proprietary NO-donating research platform, and in our internal programs combining NO with other undisclosed pharmacological mechanisms of action. We expect to be able to announce a preclinical candidate from one of these programs in the next 18 months.
- VYZULTA® (latanoprostene bunod ophthalmic solution), 0.024% is now a revenue generating asset for Nicox, following the U.S. launch in December 2017 by partner Bausch + Lomb. In March 2018, the Company announced an amendment to the global licensing agreement under which royalties paid to Nicox on worldwide net sales of VYZULTA will increase by 1% over the original royalty on net sales above $300 million per year. In addition, the potential milestone payments payable to Nicox by Bausch + Lomb have been increased by $20 million.
- We expect to ship commercial product and trade samples for ZERVIATETM (cetirizine ophthalmic solution), 0.24% to our partner Eyevance by Q1 2019, which will allow Eyevance to launch ZERVIATETM in the United States in time for the 2019 spring allergy season. The shipment of product triggers a $1 million milestone payment to Nicox by Eyevance, with up to $3 million of potential future milestones payments related to certain regulatory acceptance provisions and certain near term manufacturing objectives.
H1 2018 Financial Summary
Net revenue1 for the first half of 2018 was €0.3 million, comprised exclusively of royalties on H1 2018 sales of VYZULTATM by global partner Bausch + Lomb, after deduction of royalty payments due by Nicox. The Nicox Group recorded no revenues for the first half of 2017.
The operating expenses for the first half of 2018 were consistent with the same period last year (€10.0 million for the first six months of 2018 compared to €10.2 million for the first six months of 2017).
The Nicox Group recorded a net loss of €7.6 million for the six months ended June 30, 2018, compared to a net loss of €12.2 million for the same period in 2017.
As of June 30, 2018, the Nicox Group had cash and cash equivalents of €32.7 million as compared with €36.3 million at March 31, 2018 and €41.4 million at December 31, 2017.
1. Net revenue consists of revenue from collaborations less royalty payments which corresponds to Net profit from collaborations in the condensed consolidated statements of profit or loss for the six-month periods ended June 30, 2018.
The diligences related to the half-year review were performed by the auditors. The review report will be issued once procedures will be finalized over the half-year financial report.