Nicox SA announced the results of the Whistler Phase 3b exploratory clinical trial investigating the dual mechanism of action (nitric oxide and prostaglandin analog) of NCX 470 in intraocular pressure (IOP) lowering in healthy volunteers and ocular hypertensive patients.
The company believes that the outcomes in favor of NCX 470 in several trabecular meshwork aqueous humour dynamics parameters are due to nitric oxide. The positive exploratory results suggest that further investigation may be warranted into the dual mechanism effect of NCX 470 on intraocular pressure.
According to the company, the therapeutic characteristics of NCX 470 demonstrated in the Phase 3 program so far shows that the company has an approvable and differentiated asset with a promising clinical profile. It looks forward to announcing the safety and efficacy results from its ongoing Phase 3 trial, Denali, expected in the third quarter of this year.
The Whistler Phase 3b exploratory trial was a double-masked, placebo-controlled study designed to further our understanding of the action of NCX 470 ophthalmic solution, 0.1%, on various aqueous humor dynamic parameters in 18 healthy volunteers or subjects with ocular hypertension.
Measurements were taken at baseline and after 8 days at 1 pm and, for some parameters, at 3 pm.
The company noted that outflow facility was positive at 1 pm (p=0.081), significant at 3 pm (p=0.001), as was the diurnal outflow (p=0.004). The company believes the change is due to the effect of nitric oxide on the trabecular meshwork.
intraocular pressure lowering and uveoscleral outflow were statistically significant at all timepoints measured, whilst episcleral venous pressure did not show a notable trend.
The findings support the dual mechanism of action for IOP lowering of NCX 470 through both the conventional (nitric oxide-stimulated) and the uveoscleral (prostaglandin-stimulated) pathways. The safety profile observed was consistent with that of the first Phase 3 trial, Mont Blanc.
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