OptiNose reports positive results from study of fluticasone delivered by novel device in refractory CRS

Today OptiNose Inc. announced the positive results of a study evaluating the efficacy of fluticasone when delivered by the Company's novel bi-directional technology in patients with refractory chronic rhinosinusitis (CRS). The results of the study have been published in an article in the September issue of Rhinology.

“Preliminary efficacy of fluticasone delivered by a novel device in recalcitrant chronic rhinosinusitis”

The paper, entitled "Preliminary efficacy of fluticasone delivered by a novel device in recalcitrant chronic rhinosinusitis," is authored by rhinologists Fleur S. Hansen, M.D., Per G. Djupesland, M.D., Ph.D., Chief Scientific Officer (CSO) of OptiNose and inventor of the Company's bi-directional delivery technology, and the principle investigator, Professor Wytske J. Fokkens, M.D., Ph.D., Chair of ENT Department at the Academic Medical Centre, Amsterdam, The Netherlands. The results show administering fluticasone with OptiNose's device is effective in the treatment of refractory CRS, with significant and clinically relevant improvements compared with placebo in both subjective and objective measures of the disease.

Chronic rhinosinusitis affects approximately 12 percent of Americans below the age of 45, causing both physical symptoms and reduced quality of life. In Europe, between 7 and 27 percent of the urban population has been reported to have CRS. While current medical therapies including oral steroids, antibiotics and intranasal steroids may reduce inflammation and relieve symptoms, many patients and healthcare providers remain unsatisfied with these options. Frustratingly, many recent trials with novel topical and systemic treatment modalities have failed, leaving a substantial opportunity for improved treatments.

Professor Fokkens commented, "Chronic rhinosinusitis can be very debilitating and these results are encouraging for patients suffering from this disease. There is a significant unmet medical need in CRS given the limitations of current treatment options. This study demonstrates the importance of how treatment delivery can be a key determinant of treatment success. OptiNose's bi-directional technology showed remarkably good results in patients with chronic rhinosinusitis who did not sufficiently respond to standard medical treatment and repeated surgery."

Highlights of the prospective, randomized, double-blind, placebo-controlled, parallel study of 20 adult patients with longstanding refractory CRS to medical and surgical treatment include:

Objective Results:

• Endoscopy score for inflammatory mucosal swelling in the key region for sinus ventilation, showed a significant and progressive improvement and normalization after 12 weeks treatment of the severely swollen mucosa.
• After 12 weeks, there were significant improvements in the MRI scores in the OptiNose group as compared to baseline and a positive trend as compared to placebo.

Subjective Results:

• The nasal domain of the quality of life assessment (RSOM-31) was significantly improved with OptiNose treatment as compared with placebo.
• Nasal discomfort and combined scores were significantly improved during morning and evening periods.
• Sense of smell was improved with statistically significant scores versus placebo after 12 weeks.

Per G. Djupesland commented, "The results of this study provide preliminary evidence suggesting fluticasone coupled with OptiNose's technology is an effective and well-tolerated treatment for patients with chronic rhinosinusitis. The key to OptiNose's success is its ability to transport an effective anti-inflammatory medication to targeted areas beyond the nasal valve, including the middle meatus, which is key for normal sinus ventilation, normal function of the nose and the sense of smell. These findings corroborate the results of previous studies on patients with CRS and provide further evidence suggesting that the OptiNose drug delivery technology may have a significant impact on patients across multiple medical conditions."