Nicox Updates on Corporate, Pipeline and Financing Perspectives and Will Hold a Webcast on March 18, 2024 - Seite 2

Update on Development Pipeline

 

• NCX 470, our lead clinical asset, is a novel nitric oxide-donating bimatoprost eye drop. The Denali Phase 3 clinical trial evaluating NCX 470 for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, being conducted in the U.S. and China, is on track to generate topline results in H2 2025.   80% of the target number of patients have been randomized in the trial and completion of recruitment of U.S. patients is expected in Q4 2024. Supportive development data required for the preparation of the U.S. New Drug Application (NDA) is expected to be available on or before the completion of the Denali trial. The database from the trial will not be locked until after the last patient has completed their final trial visit in China, which drives the timing of the Denali results.

 

 

The Whistler Phase 3b trial investigating the dual mechanism of action of NCX 470 in IOP lowering is underway and results are expected in Q1 2025. The Phase 3b optical coherence tomography (OCT) trial to investigate the potential benefits of NCX 470 on the retina is not included in the current plan, however this development will be revisited when finances allow. Neither of the two Phase 3b trials are required for an NDA submission in either the U.S. or China. The potential of NCX 470 has been validated by our established partnerships with Ocumension and more recently with Kowa, for China and Japan respectively. With the completion of the Denali trial, Nicox expects to be in a position to partner NCX 470 for commercialization in the U.S. and potentially other territories. Mont Blanc and Denali trials have been designed to fulfill the regulatory requirements for safety and efficacy Phase 3 trials to support NDA submissions in both the U.S. and in China, where NCX 470 is exclusively licensed to Ocumension.

 

• NCX 1 728, an NO-donating phosphodiesterase-5 (NO-PDE5) inhibitor, is a preclinical asset with potential for development in retinal conditions. The United States Patent Office (USPTO) recently issued the Notice of Allowance for the patent covering NO-PDE5 inhibitors including NCX1728, with an expiry date in 2039. Nonclinical data have demonstrated potential for the development of NCX 1728 in a number of ophthalmic conditions and we are exploring continuing the development of this product candidate through partnerships.
• NCX 4251, a novel suspension of fluticasone propionate nanocrystals, is at development stage for dry eye disease. The Company has agreed a development plan with the U.S. Food and Drug Administration (FDA) for a Phase 3 program in dry eye disease, and this asset is available for partnering outside China. NCX 4251 is licensed to Ocumension in China who are currently reviewing the pharmaceutical development activities which would be needed to enter in clinical trials in China.