Nicox Reports Positive Results of Secondary Analyses from Phase 2 Trial Further Highlighting Potential of NCX 470 in Glaucoma

Nicox announced the results of secondary analyses of its Dolomites phase 2 trial with NCX 470 for the reduction of IOP in patients with open-angle glaucoma or ocular hypertension. Positive topline results were reported on October 2, 2019.

“The secondary analyses we report today provide further strong support to the compelling clinical potential of NCX 470 in the treatment of ocular hypertension and glaucoma,” Michele Garufi, Chairman and Chief Executive Officer of Nicox, said in a company news release. “Furthermore, the primary market research we have conducted in the U.S. via an independent agency already indicates the clear commercial opportunity of NCX 470.”

Tomas Navratil, Ph.D., EVP and Head of Development, stated, “As the next step, in our end-of-phase 2 meeting with the U.S. FDA early next year, we intend to propose conducting our phase 3 trials with 0.065%, the highest concentration used in the Dolomites trial, and a 0.1% concentration. This higher concentration has the potential for additional incremental improvement in IOP lowering, thus further enhancing the clinical and commercial profile of NCX 470.”

In the Dolomites trial, NCX 470 met the primary endpoint of noninferiority and also demonstrated statistical superiority to latanoprost, the U.S. market leader in prostaglandin analog prescriptions, in multiple pre-specified analyses, with a 7.6 to 9.8 mmHg IOP reduction from baseline.

Key Points from Additional Analysis of Dolomites Trial

• All doses of NCX 470 (0.021%, 0.042%, and 0.065%) met pre-specified primary efficacy endpoint of non-inferiority to latanoprost for reduction from baseline in mean diurnal IOP at Day 28.
• Dose dependent IOP reduction from baseline in mean diurnal IOP at Day 28 showed improved IOP lowering with each incremental concentration of NCX 470 tested, thus creating the potential for additional IOP lowering with a higher concentration of NCX 470 which, subject to FDA agreement, we intend to test in Phase 3 clinical trials.
• In a responder analysis, 37% of patients demonstrated an IOP reduction of ≥ 2 mmHg vs. the mean IOP reduction with latanoprost, and 27% of patients for ≥ 3 mmHg.
• NCX 470 was well tolerated.  The most frequently reported adverse event was conjunctival hyperemia in 16.8% of the NCX 470 (0.065%) patients vs. 6.5% of latanoprost patients; most of these events were rated as mild.  There were no drug-related serious adverse events and no evidence of treatment-related systemic effects.