OptiNose announced positive results from a second phase 3 trial, NAVIGATE I, evaluating the safety and efficacy of OPN-375 for the treatment of nasal polyposis, a type of Chronic Nasal Inflammatory Disease (CNID), and the associated symptoms of the disease.
Data from NAVIGATE I follows and confirms the positive results from the first trial, NAVIGATE II. The NAVIGATE studies are two randomized, double-blind, placebo-controlled, parallel-group, multicenter trials evaluating the safety and efficacy of three different doses of OPN-375 in patients with bilateral nasal polyposis. In the NAVIGATE I study, 323 patients with nasal polyps and associated nasal congestion were randomized to receive either placebo or one of three doses (100, 200 or 400µg) of OPN-375 for the first 16 weeks, and with all receiving open-label OPN-375 for the following eight weeks.
Study results show that patients treated with OPN-375 experienced statistically significant benefits on both co-primary endpoints: reduction of patient-rated nasal congestion/obstruction symptoms (P<0.01) and endoscopically measured reduction in total polyp grade (P<0.01). Additionally, >70% of patients were found to have a 1 point or greater improvement in polyp grade, with some (up to 29% of the group using the highest dose tested) found to have complete elimination of polyps in at least one nostril (polyp grade 0) after six months.
OPN-375 is a drug-device combination product that uses OptiNose’s patented technology to deliver fluticasone, a topical steroid, into the nasal cavity in both a targeted and a deeply distributed manner.
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