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- Outcome of the Mont Blanc Phase 3 trial suggests potential commercial alternative of NCX 470 in the United States as a novel alternative remedy for intraocular stress reducing
- Plans to generate scientific knowledge aiming to display the potential retinal advantages of NCX 470 so as to add important therapeutic worth to the product profile in glaucoma
- Intention to harness the worth of NCX 470 by way of the best business partnerships in the United States and Japan
November 7, 2022 – launch at 7:30 am CET
Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), a world ophthalmology firm, as we speak introduced future growth and partnering plans for NCX 470, a novel nitric oxide (NO)-donating bimatoprost eye drop, at present in Phase 3 growth for the reducing of intraocular stress (IOP) in sufferers with open-angle glaucoma or ocular hypertension.
“Our market research shows an unmet need in glaucoma treatment focused on lowering of intraocular pressure. Patients do not react to glaucoma medications in the same way, with up to 40% not achieving their target intraocular pressure on existing monotherapies, and therefore eye care professionals need multiple treatment options. Based on a dual mechanism of action, NCX 470 has been shown to be an effective agent for lowering intraocular pressure. Mont Blanc, the first of two Phase 3 trials for NCX 470, met the efficacy requirement for approval in the United States whilst demonstrating good tolerability in comparison to current products. The Mont Blanc trial demonstrated that NCX 470 reduced intraocular pressure by 8-9.7 mmHg, achieving its primary objective of demonstrating non–inferiority to latanoprost and we believe that NCX 470 can be successfully commercialized in key glaucoma markets including the United States, as well as China, where we have partnered with Ocumension Therapeutics. We are also planning to meet with the European Medicines Agency to discuss the regulatory requirements for the approval of NCX 470 in Europe,” stated Andreas Segerros, Chief Executive Officer of Nicox. “In parallel, we plan to strengthen the profile of NCX 470 to maximize its therapeutic and commercial potential, by generating clinical data highlighting its potential retinal benefits, and we expect to support this with additional detailed analysis of the intraocular pressure data from the Mont Blanc trial together with planned nonclinical studies.”
“We are enthusiastic concerning the potential of NCX 470 in the Chinese market, based on the positive results from the Mont Blanc trial. 8 to 9.7 mmHg reduction in intraocular pressure sets the stage for the launch of this product as a new entrant in the Chinese glaucoma market. We look forward to continuing the collaboration with Nicox to bring NCX 470 to market,” stated Liu Ye, Chief Executive Officer of Ocumension Therapeutics.
Potential partnership alternatives for NCX 470
“To complement our strong Chinese partnership, and maximize the potential future value of NCX 470, we are actively exploring commercial partnerships for NCX 470 in both the United States and Japanese markets,” stated Gavin Spencer, EVP, Chief Business Officer of Nicox. “We expect the potential of NCX 470 can be harnessed by establishing strong commercial partnerships which can support the pricing and reimbursement work necessary for a successful launch, and developing additional clinical and nonclinical support for the therapeutic profile of NCX 470, such as the data we aim to generate on NCX 470’s potential retinal benefits and the results from the ongoing Denali trial.”
Program of research to display potential retinal advantages of NCX 470
“We have consulted with Key Opinion Leaders with expertise in the damage caused in the retina by glaucoma, including some of our Glaucoma Clinical Advisory Board members, who are enthusiastic about the potential of NCX 470 in this area. With their expert knowledge, we have outlined a program of nonclinical and clinical studies to explore the activity of NCX 470 in the retina,” stated Doug Hubatsch, EVP, Chief Scientific Officer at Nicox. “These studies are expected to generate nonclinical and clinical data within the next 12 to 18 months to support the differentiation of NCX 470.”
The program of research is deliberate to incorporate analysis of the impact of NCX 470 on ocular perfusion stress by way of Episcleral Venous Pressure (EVP) and Optical Coherence Tomography (OCT) measurements of retinal vessels by which NCX 470’s capability to decrease episcleral venous stress in addition to improve outflow by way of the trabecular meshwork can be evaluated. Additionally, retinal blood vessel density can be studied in a separate scientific trial utilizing OCT-angiography to totally perceive results on retinal blood circulation. Together, these research are designed to validate NCX 470’s twin mechanism of motion in people and probably display among the helpful results on the retina which were noticed in nonclinical fashions.
The deliberate initiation of those scientific research is included within the Company’s money runway to mid-November, 2023, nevertheless the research should not anticipated to be accomplished by that date and would require extra funding.
Rationale for retinal profit and the function of nitric oxide (NO)
Elevated IOP is the principle danger think about glaucoma; nevertheless, a wide range of IOP-independent danger components, together with ischemia (insufficient blood provide), contribute to break of the optic nerve head and the retina, finally inflicting imaginative and prescient loss. NO is a potent vasodilator, and Nicox has beforehand demonstrated1 a partial reversal of the ischemic results on ocular hemodynamics and retinal dysfunction by administering a Nicox NO-donating compound. We additionally just lately reported2 nonclinical ends in an ischemia/reperfusion mannequin suggesting that NCX 470 improves ocular perfusion and retinal operate in broken eyes in comparison with automobile and due to this fact might have therapeutic properties past reducing of IOP.
About NCX 470
NCX 470 is a novel, nitric oxide (NO)-donating bimatoprost eye drop that leverages the potent IOP-lowering results of NO and prostaglandin analogs (PGAs). NCX 470 incorporates Nicox’s proprietary NO-donating analysis platform and bimatoprost in a single molecule. NCX 470 is designed to launch bimatoprost and NO into the attention to decrease IOP by two pathways in sufferers with open-angle glaucoma or ocular hypertension. NO is a well known, small, naturally-occurring signaling molecule that performs a key function within the regulation of IOP by way of activation of soluble guanylate cyclase (sGC). NO brings extra IOP-lowering efficacy by enhancing aqueous humor drainage from the attention through a unique mechanism of motion than that engaged by prostaglandin analogs. Bimatoprost, marketed beneath the model identify LUMIGAN® by AbbVie, Inc., is the main branded PGA. PGAs are essentially the most broadly used class of medication for IOP-lowering in sufferers with open-angle glaucoma or ocular hypertension.
NCX 470 is at present in Phase 3 growth for the reducing of intraocular stress in sufferers with open-angle glaucoma or elevated intraocular stress. The program consists of two trials, Mont Blanc and Denali. Topline outcomes from the Mont Blanc trial have been reported on October 31, 2022. The equally designed, ongoing, second Phase 3 trial, Denali, is being carried out at scientific websites within the U.S. and China, with topline outcomes anticipated after 2024. The Denali trial additionally features a long run security extension by way of to 12 months, and is being collectively carried out and equally financed with our Chinese companion, Ocumension Therapeutics.
The Mont Blanc and Denali trials have been designed to satisfy the regulatory necessities to help New Drug Application (NDA) submissions within the U.S. and China and may even present knowledge for different international locations accepting the identical scientific knowledge package deal for approval. The design of the efficacy a part of the Denali trial is equivalent to that of Mont Blanc, nevertheless there isn’t a assure that the outcomes would be the identical. Both trials are needed, and sure extra scientific and nonclinical knowledge may even be required, to finish NDA submissions in each the U.S. and China. Should NCX 470 be developed for different territories, for instance Europe or Japan, there could also be extra necessities.
Corporate Update
Nicox is concentrated on finishing the evaluation of the Mont Blanc knowledge, which can be introduced at key upcoming scientific congresses, the continued NCX 470 Denali Phase 3 glaucoma trial and investigating the potential retinal advantages of NCX 470 in a program of each nonclinical and scientific research. In addition, analysis actions proceed on NCX 1728, the lead candidate in a brand new class of molecules, the NO-donating phosphodiesterase-5 inhibitors in each IOP reducing and retinal safety.
Given that the Mont Blanc Phase 3 scientific trial of NCX 470 met its main goal of non-inferiority to latanoprost, the Company has met the situation essential to train its choice to increase the interval of interest-only fee of its current Kreos debt by six months to January 1, 2024. Nicox might train this feature at any time till August 1, 2023. If this feature just isn’t exercised, the curiosity solely interval will finish on July 1, 2023.
The Company estimates that it’s financed till mid-November 2023, and till mid-December 2023 assuming the extension of the curiosity solely interval of the prevailing Kreos debt, in each circumstances primarily based on the event of NCX 470 alone.
