December 16, 2021 – release at 7:30 am CET
Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that the first patient has been screened in China as part of the ongoing Denali Phase 3 clinical trial, paving the way for submissions new drugs (NDAs) in the United States. (US) and China for NCX 470, Nicox’s lead clinical product candidate in glaucoma. Denali, which also includes a long-term safety extension, has been recruiting patients in the United States since November 2020. Approximately 670 patients are expected to be randomized at approximately 60 clinical sites in the United States and China, with approximately 80% of patients in to be recruited from the United States and the remaining 20% of patients to be recruited from China. This is the first patient to be included in the Chinese part of the trial. Denali’s results are expected by the end of 2023.
Denali Phase 3 Trial Evaluates the Intraocular Pressure (IOP) Lowering Efficacy of NCX 470 Ophthalmic Solution Given Once Daily at 0.1% versus Latanoprost Ophthalmic Solution 0.005% in patients with open-angle glaucoma or ocular hypertension. Denali is a multi-regional clinical trial (US and China) funded equally by Nicox and Ocumension, Nicox’s exclusive licensee for China, Korea and Southeast Asia. Inclusion of Chinese patients in the Denali trial is essential to meet the requirements of the Chinese regulatory authority, the National Medical Products Administration. The Denali assay was designed to meet regulatory requirements to support NCX 470 NDA submissions in the United States and China.
Gavin Spencer, Commercial Director of Nicox commented “Initiation of the Chinese side of the Denali trial marks an important step in the realisation of the multiregional clinical strategy that we have adopted through our agreements with Ocumension. Through Supporting double regulatory submissions in high value Marlets – the we and China – we can bring the next generation lowering of intraocular pressure rapid and effective treatment for patients. Our partnership with Ocumension potentially accelerates the development of several programs, not only NCX 470 but also ZERVIATE® and NCX 4251.“
NCX 470 is a novel nitric oxide donor prostaglandin analogue with the potential for greater IOP lowering activity than currently marketed products. In addition to the Denali trial, NCX 470 is also being evaluated in the Mont Blanc Phase 3 clinical trial, the results of which are expected in the first quarter of 2023.
“NCX 470 is one of the key development assets in our pipeline, allowing bring us an effective new therapy in the Chinese glaucoma market, which is expected to grow exponentially over the next decade. Nicox’s approach in design a multi-regional, US-China The phase 3 program has accelerated the development of the NCX 470 for us, and We are satisfied with the Nicox collaboration on all fronts. added Victor Liu, Managing Director of Ocumension Therapeutics.
Nicox has licensed the exclusive rights to Ocumension for the NCX 470 in China, Korea and Southeast Asia. Ocumension paid € 18 million to Nicox and is also funding 50% of the costs of Denali’s Phase 3 clinical trial. Nicox will also receive tiered royalties of between 6% and 12% on sales of NCX 470 by Ocumension. Ocumension is a Chinese ophthalmology company listed on the Hong Kong Stock Exchange in 2020 (HKEX: OCUMENSION-B (1477), market capitalization USD 1.4 billion).
Ocumension also has rights to ZERVIATE® in China and much of Southeast Asia, and is currently conducting a Phase 3 clinical trial to support a regulatory approval application for allergic conjunctivitis in China. Ocumension also owns the rights in China to Nicox’s second clinical product candidate, NCX 4251.