OptiNose AS announced that its Phase III ReOpen1 clinical trial met both of its co-primary endpoints. It will be used to treat patients diagnosed with chronic sinusitis.
Representation of chronic sinusitis.
OptiNose AS, a Pennsylvania-based pharmaceutical company focusing on treating ear, nose and throat and allergy diseases, announced that its Phase III ReOpen1 clinical trial met both of its co-primary endpoints. The news is hopeful for patients suffering from chronic sinusitis as well for investors in the company stock.
The ReOpen1 clinical trial is a global, randomized, double-blind, placebo-controlled study for OptiNose’s XHANCE® (fluticasone propionate) Exhalation Delivery System™. XHANCE is a drug administered intranasally. In the study, 332 patients with chronic sinusitis were administered doses of 186 and 372 mcg twice daily over 24 weeks. The study included patients with and without nasal polyps.
The trial’s primary endpoints were to solve the two major symptoms of sinusitis: the first, a composite score of nasal congestion and facial pressure sensation with nasal discharge; and the second, ethmoid and maxillary sinus volume occupied by inflammation or disease, which was calculated with a CT scan.
Results of Phase III ReOpen1 trial to Find Chronic Sinusitis Treatment
When the study concluded, the results were impressive. Both co-primary endpoints were met, and the data showed a statistically significant improvement in patients with chronic sinusitis who received the XHANCE treatment compared to patients who were treated by a placebo.
Additionally, the safety and tolerability of XHANCE was confirmed. Safety and tolerability were in line with its labeled safety profile. There were, however, a few adverse events that occurred at a rate of more than 3%, including side effects such as epistaxis, nasopharyngitis, asthma and nuclear and cortical cataracts.
News of this effective and relatively well-tolerated treatment could spell relief for patients. Around 30 million adults in the United States suffer from chronic sinusitis. Currently, most treatments for sinusitis include hefty antibiotic courses.
“There are no prior phase 3 trials that show intranasal drug treatment reduces inflammation inside the sinus cavities of people with chronic sinusitis. If replicated, these findings may lead to XHANCE being the first-ever drug approved for chronic sinusitis and potentially a change in standard of care for chronic sinusitis patients,” said James Palmer, M.D., former president of the American Rhinologic Society.
Details from the trial will be published in a peer-reviewed journal, and OptiNose shared plans to present the data at future meetings.
The news also piqued the curiosity of investors. Shares of OptiNose jumped 29% in pre-market trading when the results of the chronic sinusitis treatment study were announced. Seeing as XHANCE net product revenue hit $18.4 million in Q2 2021 alone, the financial benefits of XHANCE becoming FDA-approved could be significant for shareholders. OptiNose expected the full product revenue for the year 2021 to top $80 million.
Beyond these results, OptiNose has a powerful pipeline of news planned. ReOpen2, a second Phase III trial for XHANCE, is nearing completion, and OptiNose expects to share top-line results in Q2 2022.
OptiNose CEO Peter Miller is also expected to announce the results of the company’s Q4 2021 revenue in a financial update before the market opens Tuesday. On Wednesday, March 9, Miller also plans to present a company overview and business update at the Cowen 42nd Annual Health Care Conference.
