OptiNose's bi-directional nasal device delivering fluticasone effective in reducing nasal polyps in CRS patients

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.

James N. Palmer, M.D., Associate Professor, Director of the Division of Rhinology, Department of Otorhinolaryngology: Head and Neck Surgery at the University of Pennsylvania, commented, "Chronic Rhinosinusitis can be a debilitating condition and the current medical therapies ranging from the combination of conventional nasal sprays and nasal powder inhalers with intranasal steroid regimens, to antibiotics alone, and even surgery, often prove inadequate. A bi-directional approach to drug delivery could represent a way to deliver product to treat those who suffer from chronic rhinosinusitis with polyps. These study results seem to suggest greater efficacy in treating nasal polyps than existing methods and with further validation may be a means to avoid sinus surgery in certain cases."

Peter Miller, CEO of OptiNose Inc. commented, "We are encouraged by our findings across the Phase II clinical trials and particularly by the data represented in this subgroup analysis. We are now focusing on structuring a Phase III program towards conclusively demonstrating better efficacy of OptiNose's products for the treatment of both chronic rhinosinusitis with nasal polyps and for migraines. Looking further out, these results support our belief that bi-directional drug delivery technology through the nasal cavity holds promising value to deliver therapies that effectively address challenging conditions across multiple platforms including central nervous system disorders."

In June 2010, OptiNose received a $48.5 million investment from New York-based private equity firm Avista Capital Partners to support Phase III trials and enable the company to build out its clinical development and commercialization infrastructure. In conjunction with the investment, OptiNose reincorporated the business in the U.S. and moved its headquarters from Oslo, Norway to Yardley, PA. Relatedly, the Company appointed most recently President and Chief Executive Officer of Take Care Health Systems and former Johnson & Johnson senior executive, Peter Miller to the position of Chief Executive Officer.