Nicox provided certain regulatory and clinical updates for NCX 470, its novel nitric oxide (NO) donating bimatoprost analog being developed for IOP lowering.
Nicox held a preinvestigational new drug (IND) meeting with the FDA at the end of 2016. Based on the feedback from this meeting, Nicox is finalizing the design of a first-in-human trial for NCX 470 which will be a phase 2 multicenter, investigator masked, 28-day, parallel group, dose-finding study in adult subjects with elevated IOP due to open-angle glaucoma or ocular hypertension. Multiple doses of NCX 470 will be compared in safety and efficacy to bimatoprost. The primary endpoint of the study is the mean reduction in IOP, and the objective is to identify the appropriate safe and effective dose of NCX 470 to be taken into phase 3 studies. Recruitment of subjects is expected to begin in early 2018, subject to IND filing and acceptance, and the study is expected to take approximately 1 year to complete.
“All pharmacological treatments currently available and in advanced stages of development for glaucoma target the lowering of IOP as each additional mmHg reduction results in a 10 to 20% reduced risk of vision loss," Mike Bergamini, PhD, EVP and Chief Scientific Officer of Nicox, said in a company news release. "NCX 470 has been developed using a similar NO-donation platform to latanoprostene bunod, the Nicox molecule being developed for IOP lowering by our partner Bausch + Lomb, which is expected to launch in the US in mid-2017. We believe the clinical results of latanoprostene bunod validate the mechanism of action of NO-donating prostaglandin analogs, and we expect NCX 470 to also demonstrate considerable IOP lowering activity. Our R&D team is currently finalising the necessary pre-IND activities to support filing of the IND in Q4 this year, allowing us to enroll subjects directly into phase 2 in early 2018.”
“NCX 470 is the second candidate molecule for which we have recently announced plans to move into the clinic within the next 12 months, further solidifying our broad pipeline of programs in ophthalmology,” Michele Garufi, Chairman and Chief Executive Officer of Nicox, said in the news release. “As with latanoprostene bunod, NCX 470 has been generated by our dedicated and experienced team of researchers who are leaders in studying the role of NO in the eye. In addition to our clinic-ready programs, we are working on other new and innovative NO-based projects currently focused on IOP lowering and glaucoma, including our proprietary next-generation of stand-alone NO-donors.”