Nicox NO-Donating Analog Effective in Phase 2 Trial

■ Nicox announced positive top-line results from its US multicenter Dolomites dose-response phase 2 clinical trial evaluating investigational NCX 470, a novel, second-generation nitric oxide (NO)-donating bimatoprost analog, compared to latanoprost ophthalmic solution 0.005% in 433 patients with open-angle glaucoma or ocular hypertension.

“We are very pleased that NCX 470 0.065% demonstrated statistical superiority to latanoprost in a prespecified secondary efficacy analysis,” said Michele Garufi, Chairman and CEO of Nicox, in a news release. “If these results are confirmed in phase 3 clinical trials, NCX 470 could potentially become the first noncombination product with statistical superiority to a prostaglandin analog. Moreover, NCX 470 has demonstrated what we believe to be the highest IOP reduction from baseline in a glaucoma clinical trial with up to 9.8 mmHg in time-matched IOP. We are planning an end-of-phase-2 meeting with the FDA early next year to finalize plans to conduct the phase 3 trials against a prostaglandin analog.”

In the trial, statistical noninferiority was met vs latanoprost in the primary efficacy analysis (mean diurnal IOP reduction from baseline at day 28). The IOP-lowering effect of NCX 470 0.065% from baseline was 7.6 mmHg to 9.8 mmHg, and for latanoprost, it was 6.3 mmHg to 8.8 mmHg; there was a reduction in time-matched IOP at 8 AM, 10 AM, and 4 PM across all visits. NCX 470 was well tolerated; the most frequent adverse event was conjunctival hyperemia in 16.8% of the NCX 470 0.065% patients, whereas hyperemia was seen in 6.5% of latanoprost patients. Most events were rated as mild, and there were no drug-related serious adverse events or evidence of treatment-related systemic effects.