Nicox Announces First Patient in China screened in the ongoing NCX 470 Denali Phase 3 Trial in Glaucoma
Nicox SA announced that the first patient has been screened in China in the ongoing Denali phase 3 clinical trial, opening the way for new drug application (NDA) submissions in both the United States 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 US since November 2020. Approximately 670 patients are expected to be randomized at approximately 60 clinical sites in the US and China, with approximately 80% of the patients to be recruited in the US and the remaining ~20% of the patients to be recruited in China. This is the first patient to be enrolled in the Chinese part of the trial. Results from Denali are expected by the end of 2023.
The Denali phase 3 trial evaluates the IOP lowering efficacy of once-daily dosed NCX 470 ophthalmic solution 0.1% compared to latanoprost ophthalmic solution 0.005% in patients with open-angle glaucoma or ocular hypertension. Denali is a multiregional (U.S. and China) clinical trial financed equally by Nicox and Ocumension, Nicox’s exclusive licensee for China, Korea and Southeast Asia. The inclusion of Chinese patients in the Denali trial is essential to satisfy the requirements of Chinese regulatory authority, the National Medical Products Administration. The Denali trial was designed to fulfill the regulatory requirements to support NDA submissions of NCX 470 in the U.S. and China.
“The initiation of the Chinese part of the Denali trial marks an important step forward in the realization of the multiregional clinical strategy that we have adopted through our agreements with Ocumension," Gavin Spencer, Chief Business Officer of Nicox, said in a company news release. "By supporting dual regulatory submissions in high-value markets—the U.S. and China—we can bring next-generation intraocular pressure-lowering treatments rapidly and efficiently to patients. Our partnership with Ocumension potentially accelerates the development of multiple programs, not only NCX 470 but also Zerviate and NCX 4251.”
NCX 470 is a novel nitric oxide-donating prostaglandin analog 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, with its results expected in Q1 2023.
“NCX 470 is one of the key development assets in our pipeline, allowing us to bring an efficacious, novel therapeutic into the Chinese glaucoma market, which is expected to grow exponentially over the next decade. The approach of Nicox in designing a multi-regional, US-China phase 3 program has accelerated the development of NCX 470 for us, and we are pleased with the Nicox collaboration on all fronts.” added Victor Liu, Chief Executive Officer of Ocumension Therapeutics.
Nicox has licensed exclusive rights to Ocumension for NCX 470 in China, Korea and Southeast Asia. Ocumension has paid €18 million to Nicox, and is also funding 50% of the Denali phase 3 clinical trial costs. Nicox also stands to receive tiered royalties of between 6% and 12% on sales of NCX 470 by Ocumension. Ocumension is a Chinese ophthalmology company that 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 the majority of Southeast Asia, and is currently running a phase 3 clinical trial intended to support an application for regulatory approval for allergic conjunctivitis in China. Ocumension also has rights in China to Nicox’s second clinical product candidate, NCX 4251.