PHILADELPHIA, PA – April 17, 2009. OptiNose today announced important new results from a Phase II trial of its novel nasal drug delivery device with fluticasone for the treatment of chronic rhinosinusitis. Patients in the active treatment group experienced significant improvements in nasal symptoms, nasal discomfort and sense of smell. There was also a highly significant and progressive reduction in nasal swelling.
The results from the study, which was conducted at the AMC in Amsterdam, Holland with Professor Wytske Fokkens as the principal investigator, were presented at the Rhinology World conference in Philadelphia. Patients self-administered fluticasone propionate 400 μg or placebo twice-daily at home over a 12-week period using the OptiNose delivery device. Endoscopic assessment of the nasal mucosa showed a highly significant and progressive improvement to a normal state in the actively treated group. At the post-study examination 30% had a normal ENT-examination. Peak nasal inspiratory flow and rhinosinusitis outcome measures were also significantly improved. MR imaging before and after treatment, showed significant improvement compared to baseline.
“We are extremely pleased with the effectiveness of our treatment for chronic rhinosinusitis”, said ENT-specialist Per Djupesland, M.D., Ph.D., the study’s co-author and Chief Scientific Officer at OptiNose AS. “This disease is difficult to treat and there is currently no product available in the US that has been approved by the FDA. Many recent clinical trials in CRS patients have been unsuccessful, leaving millions of suffering patients with an unmet need. These results suggest that we now have a highly promising new therapy”
This is the third Phase II trial OptiNose has conducted demonstrating the effectiveness of its novel device in delivering drugs to target sites throughout the nasal cavity. A previous study showed that OptiNose’s novel device with fluticasone was highly effective in the treatment of chronic rhinosinusitis with nasal polyps.
About OptiNose Inc.
OptiNose is a drug delivery company with breakthrough bi-directional nasal technology set to transform the static nasal drug delivery market. Founded in 2000, OptiNose’s devices are designed to deliver intranasal drugs to target regions of the nasal cavity, including the sinuses and the olfactory region while preventing lung deposition. The company offers both single and multi-use intranasal delivery devices for liquid and powder formulations. The technology has been successfully tested in a number of clinical trials with results confirming the superiority of the technology compared to traditional nasal sprays. Investors in OptiNose include Avista Capital Partners in New York, WFD Ventures LLC located in New York and Entrepreneurs Fund LP based in Jersey, Channel Islands. For more information please visit www.OptiNose.com.
About Bi-directional Nasal Delivery Technology
OptiNose’s bidirectional nasal delivery technology significantly improves delivery to the targeted sites deep into the nose. While exhaling into the device, the soft palate automatically closes off the nasal cavity completely. The breath enters one nostril through a sealing nozzle and triggers the release of drug particles into the airflow. This action causes the narrow nasal passages to expand and carry these particles beyond the nasal valve to targeted sites. After delivering drug particles to the targeted sites, the air flow then exits the nasal cavity through the other nasal passage in the opposite direction.