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03.07.2023 07:30:00
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Nicox Presented NCX 470 Phase 3 Mont Blanc Adaptive Design Data and Additional Subset Analysis Showing Superiority over Latanoprost at the World Glaucoma Congress
| Press Release | ||
| Nicox Presented NCX 470 Phase 3 Mont Blanc Adaptive Design Data and Additional Subset Analysis Showing Superiority over Latanoprost at the World Glaucoma Congress | ||
July 3, 2023 – release at 7:30 am CET Sophia Antipolis, France Nicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced that additional data on NCX 470 have been presented at the 10th World Glaucoma Congress (WGC) being held from June 28 to July 1, 2023 in Rome, Italy. "The large volume of data generated in the Mont Blanc Phase 3 trial on NCX 470 has provided us with the opportunity to look in detail at patient subgroups to further evaluate where NCX 470 has the greatest effect, some of which we are reporting here. Our first poster at the World Glaucoma Congress presents the adaptive dose selection data, justifying the choice of the 0.1% NCX 470 dose for the rest of the trial. We have also looked across the whole trial and report is that more patients achieve a reduction of IOP of 10mmHg or more when on NCX 470 than those on latanoprost. We look forward to reporting other data at conferences and in planned publications.” said Doug Hubatsch, Chief Scientific Officer of Nicox Poster Title: NCX 470, a Nitric Oxide Donating Bimatoprost Compared with Latanoprost - Adaptive Design Period Results from the Phase 3 Mont Blanc Clinical Trial A dose finding Phase 2 trial (Dolomites) tested NCX 470 at several concentrations and the results suggested that the highest studied dose might still be below the top of the dose response curve. To test this a concentration of 0.065% and 0.1% were included in an adaptive dose selection period of the Phase 3 Mont Blanc trial, which compared the safety and efficacy of NCX 470 ophthalmic solution vs. latanoprost ophthalmic solution in adult subjects with open-angle glaucoma or ocular hypertension. At the Week 2 timepoint, NCX 470 0.065% demonstrated 1.37 mmHg greater mean diurnal IOP reduction from baseline than latanoprost and NCX 0.1% demonstrated 1.73 mmHg greater mean diurnal IOP reduction from baseline than latanoprost. The adaptive dose selection period was used in place of additional dose ranging studies to select the 0.1% concentration of NCX 470 for the duration of the 3-month Phase 3 Mont Blanc clinical trial as well as the second Phase 3 trial, Denali. Poster Title: NCX 470, a Nitric Oxide Donating Bimatoprost versus Latanoprost has Greater Proportion of Subjects Achieving =10 mmHg IOP Decrease in Phase 3 Trial NCX 470 met the primary efficacy endpoint of non-inferiority to latanoprost at all 9 of 9 timepoints measured in the Mont Blanc trial. Furthermore, NCX 470 demonstrated a statistically greater proportion of subjects with 10 mmHg or more IOP reduction compared to latanoprost at Week 2, Week 6, and Month 3 ranging from 69% to 46% in the NCX 470 group compared to 60% to 34% in the latanoprost group. NCX 470 was safe and well tolerated. Poster Title: Effects of NCX 470, a Nitric Oxide (NO)-Donating Bimatoprost, in in vitro 3D-Human Trabecular Meshwork (TM) / Schlemm's Canal (SC) Tissue Model Bioengineered 3D-human TM/SC (3D-HTM/HSCTM) constructs and Cynomolgus monkeys were used to provide insights on the cellular and molecular mechanism/s accounting for NCX 470-mediated intraocular pressure (IOP)-lowering activity. NCX 470 significantly improved outflow facility in 3D-HTM/HSCTM. Furthermore, unlike most IOP-lowering agents, a clinically effective dose (0.1% ophthalmic solution) of NCX 470 affected both conventional and uveoscleral pathways to increase aqueous humor drainage from monkey eyes. NCX 470 dual-acting modality (NO and prostaglandin analog) explains the robust reduction of IOP exerted by this drug in patients with open-angle glaucoma or ocular hypertension. About NCX 470 NCX 470 is a novel NO-donating bimatoprost eye drop currently in Phase 3 clinical development for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension. The first Phase 3 trial, Mont Blanc, a randomized, double-masked, multi-center, parallel group trial that was conducted in the U.S., compared NCX 470 (0.1%) to latanoprost (0.005%) was completed in October 2022. The second Phase 3 trial, Denali, similarly designed to the Mont Blanc trial, and which includes a long-term safety extension, is ongoing. Update on planned Phase 3b trials on NCX 470 The timing of the planned Phase 3b trials investigating the dual mechanism of action (nitric oxide and prostaglandin analog) in IOP lowering and potential retinal benefits of NCX 470 is currently being assessed and we will provide an update on these in the Q2 Press Release in mid-July. | ||
| About Nicox | ||
| Nicox SA 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 bimatoprost, for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The company is also conducting research on NCX 1728, a nitric oxide-donating phosphodiesterase 5 inhibitor, in retinal conditions. NCX 4251, a novel, patented, ophthalmic suspension of fluticasone propionate nanocrystals for topical ocular application for dry eye disease, is being developed by Ocumension Therapeutics in China under an exclusive license agreement and is available for partnering elsewhere. 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 (a wholly owned subsidiary of Santen Pharmaceutical Co., Ltd.), in the U.S. and Ocumension Therapeutics in the Chinese and in the majority of Southeast Asian markets. Nicox, headquartered in Sophia Antipolis, France, is listed on Euronext Growth Paris (Ticker symbol: ALCOX) and is part of the CAC Healthcare index. For more information on Nicox, its products or pipeline, please visit: www.nicox.com. | ||
| Analyst coverage | ||
Bryan, Garnier & Co Eric Yoo Paris, France Edison Investment Research Pooya Hemami London, UK H.C. Wainwright & Co Yi Chen New York, U.S. Kepler Cheuvreux Arsene Guekam 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 | ||
| 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 section 2.7 of the ‘Rapport Annuel 2022’ which is available on Nicox’s website (www.nicox.com). | ||
| Nicox S.A. Drakkar 2 Bât D, 2405 route des Dolines 06560 Valbonne, France T +33 (0)4 97 24 53 00 F +33 (0)4 97 24 53 99 | ||
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