CHICAGO, IL – September 19, 2008 – OptiNose today announced important results from a Phase II trial of its novel nasal drug delivery device with fluticasone for the treatment of chronic rhinosinusitis with nasal polyps. Patients experienced a significant reduction in polyp size and associated symptoms, with almost 80% reporting overall improvement. The data was presented at the annual meeting of the American Rhinologic Society.
Reduction in polyp size was measured using Lildholdt’s Scale, a 4-point scale used to rate the size of nasal polyps. The proportion of subjects with a reduction in polyp score ≥1 on the Lildholdt’s Scale was significantly higher compared to placebo at 4, 8 and 12 weeks, reaching 57.4% at the study’s end vs. 9.1% for placebo. Patients also experienced significant improvements in sense of smell, nasal obstruction and nasal comfort.
“We are pleased with the effectiveness of our treatment for nasal polyps”, said Per Djupesland, M.D., Ph.D., the study’s co-author and Chief Scientific Officer at OptiNose AS. Dr. Djupesland also noted that the endpoints progressively improved as the patients advanced through the trial, whereas in many existing treatments the improvements eventually plateau within the same time period. “This raises the possibility that patients could see even greater improvements the longer they continue treatment.
This is the second 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 sumatriptan was highly effective for the treatment of migraines.
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.