Nicox Selects 0.1% NCX 470 Dose in Adaptive Stage of Mont Blanc Phase 3 Glaucoma Trial

September 23, 2020

  • The 0.1% dose of NCX 470 was selected in the adaptive stage of the Mont Blanc Phase 3 trial

  • This dose selection enables the second part of the Mont Blanc Phase 3 trial with a 1:1 head-to-head comparison vs latanoprost

  • The dose selection also enables the start of Denali, the second NCX 470 Phase 3 trial, before the end of the year

Sophia Antipolis, France

Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced the selection of the 0.1% dose of NCX 470 for Phase 3 following the completion of the adaptive portion of the Mont Blanc Phase 3 clinical trial.  As is customary for adaptive design trials, in order to maintain the integrity of the trial, no data from the adaptive portion of the trial will be disclosed until the completion of the trial.  NCX 470, Nicox’s lead clinical product candidate, is a novel second generation nitric oxide (NO)-donating bimatoprost analog.  NCX 470 is licensed to Ocumension Therapeutics for the Chinese, Korean and South East Asian markets.

“Selecting the dose for the remaining Phase 3 trials is an important milestone in the development of this high potential, novel molecule, and progress on the overall program continues to meet our expectations.  This progress demonstrates excellent performance by our development team and clinical sites in the current environment, allowing us to maintain our targeted timeline and announce top-line results from Mont Blanc by the end of 2021.” said Dr. José Boyer, Vice President and Head, Clinical Development at Nicox.

NCX 470 Phase 3 Clinical Program

Mont Blanc is a Phase 3 clinical trial evaluating NCX 470 for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.  It was initiated on June 1, 2020, and currently has 48 clinical sites enrolling patients.  Following the completion of the adaptive design portion of the trial announced today, Mont Blanc will continue as a multi-regional, double-masked, 3-month, parallel group trial evaluating the efficacy and safety of NCX 470 ophthalmic solution 0.1% compared to latanoprost ophthalmic solution, 0.005%, the most widely prescribed first-line therapy for glaucoma and ocular hypertension, randomized in a 1:1 ratio.  The primary efficacy evaluation is based on time-matched IOP at 8 AM and 4 PM at Week 2, Week 6 and Month 3.  The Mont Blanc trial is expected to randomize approximately 670 patients, at approximately 50 clinical sites in the U.S. and at a small number of clinical sites in China.  At current recruitment rates, top-line results from Mont Blanc are expected in Q4 2021.

Denali, the second Phase 3 glaucoma clinical trial, which will be jointly managed and equally funded by Nicox and our partner Ocumension Therapeutics, is expected to start before the end of this year, and will compare NCX 470 ophthalmic solution, 0.1% to latanoprost ophthalmic solution, 0.005%, randomized in a 1:1 ratio.  It will include clinical sites in both the U.S. and China, with the majority of the patients being in the U.S.  Ocumension Therapeutics has exclusive rights for the development and commercialization of NCX 470 in the Chinese, Korean and South East Asian markets.  The Denali trial was designed to fulfill the regulatory requirements to support NDA filings in the U.S. and China.

We continue to closely watch the spread of COVID-19 and its impact.  We do not currently anticipate delays to our clinical timelines but we are monitoring the situation and will provide updates if there is an impact on our development projects and timelines.

NCX 470 Phase 2 Clinical Data

In the Phase 2 Dolomites trial, NCX 470 ophthalmic solution, 0.065%, demonstrated both statistical non-inferiority and superiority to latanoprost ophthalmic solution, 0.005%.  We believe the 7.6 to 9.8 mmHg IOP reduction from baseline at 8 AM, 10 AM and 4 PM across the Week 1, 2 and 4 Visits for the 0.065% dose of NCX 470 in the Dolomites trial is the highest reduction demonstrated by an eye drop in a glaucoma clinical trial to date.

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