China-based Ocumension Therapeutics (HKG: 1477) announced the initiation of a second Phase III Denali study for its OT-301 (NCX 470) in the US, with the first patient enrolled on November 9. This marks a significant milestone in the clinical development of the drug, which is designed to lower intraocular pressure (IOP) in patients with open-angle glaucoma and ocular hypertension.
Study Design and Objectives
The three-month randomized study will enroll 670 patients across 50 centers in the US and China. It is designed to assess the safety and efficacy of OT-301 compared to the standard treatment, latanoprost, in lowering IOP. OT-301 (NCX 470) is a first-in-class second-generation nitric oxide (NO) donor bimatoprost analog that releases bemiprost and NO after administration, leveraging nitric oxide-mediated effects to lower IOP more effectively than similar products.
Regulatory and Commercial Strategy
The Denali study is intended to support new drug application (NDA) filings in both the US and China. OT-301 was in-licensed from France-based Nicox SA in a EUR 36.25 million (USD 42.6 million) deal for Greater China rights in December 2018. The first Phase III Mont Blanc study was initiated in the US in June this year and approved in China in October, with core data readout expected during the fourth quarter of 2021.
Future Outlook
With the initiation of the second Phase III study, Ocumension is well-positioned to advance OT-301 through the final stages of clinical development, aiming to provide a new and effective treatment option for patients with glaucoma and ocular hypertension.-Fineline Info & Tech
