OptiNose Inc. announced today that a subgroup analysis of positive Phase II trial results has been published in the July/August issue of the American Journal of Rhinology & Allergy.
“Impact of baseline nasal polyp size and previous surgery on efficacy of fluticasone delivered with a novel device: A subgroup analysis”
The paper is entitled "Impact of baseline nasal polyp size and previous surgery on efficacy of fluticasone delivered with a novel device: A subgroup analysis," authored by Rhinologist Per G. Djupesland, M.D., Ph.D., Chief Scientific Officer (CSO) of OptiNose and inventor of the Company's bi-directional delivery technology, Graeme Hewson and Ingrid Vlckova, Ph.D.s. The results show that OptiNose's innovative bi-directional nasal device delivering fluticasone, a nasal steroid, is highly effective in progressively reducing the size or eliminating nasal polyps in patients with chronic rhinosinustis (CRS) with nasal polyps. The results also show the drug delivery technology was equally effective in treating patients with newly diagnosed and those with recurring nasal polyps post sinus surgery.
The excellent clinical results achieved offered a unique opportunity for analysis for subgroups with different baseline polyp size. Highlights of the multicenter, randomized, double-blind, placebo-controlled, parallel-group study of 109 adult patients with mild-to-moderate bilateral nasal polyps include:
- Patients with large nasal polyps saw significantly greater reduction at 4, 8 and 12 week periods with the OptiNose/fluticasone drug delivery technology
- The largest nasal polyps showed a mean reduction of 1.69 or 42% at 12 weeks
- More than 80% of patients with larger polyps demonstrated size reduction to the degree that they are classified as small polyps
- Patients with small nasal polyps realized a significant reduction at 4, 8 and 12 week periods
- The smallest nasal polyps showed a mean reduction of 0.56 or 28% at 12 weeks
- 7 of the 27 patients in this subgroup (26%) completely resolved polyps on both sides of the nasal cavity after 12 weeks of therapy
- The data show that the treatment was just as efficient in non-surgery and surgery subgroups with both experiencing approximate 35% reduction in polyp size
Per G. Djupesland commented, "We are excited by study results that suggest our bi-directional drug delivery technology delivers a highly significant progressive treatment effect on nasal polyps of all sizes, leading to notable reduction and even complete resolution of polyps. Progressive reduction of all sized polyps is critical for successful treatment because large polyps become small polyps and then are eliminated. We were also pleased to see that our treatment is as efficient in the challenging patients with recurring polyps following sinus surgery as in patients without prior surgery. Ultimately, we believe these results reflect the better and more targeted delivery we achieve with the novel device and demonstrate a potentially better treatment for many patients who suffer from the condition."
Chronic rhinosinusitis (CRS) is a common disease, severely reducing the quality of life of millions of patients, with few effective treatments currently available. According to U.S. health statistics, approximately 25 to 30 percent of the 20 to 32 million U.S. patients with CRS have symptomatic nasal polyps. Research has shown that nasal polyps affect more men than women and typically appear in adults over the age of 30. Current medical therapy includes oral steroids, antibiotics and long-term intranasal steroids to reduce inflammation and polyp size.