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Company previously announced positive top-line results from both ReOpen1 and ReOpen2, the landmark trials evaluating XHANCE as a treatment for chronic sinusitis
Multiple secondary endpoints from ReOpen2 indicate patients treated with XHANCE experienced improvement in symptoms and quality of life when compared to patients treated with placebo
In pooled data from ReOpen1 and ReOpen2, XHANCE demonstrated a benefit relative to placebo on CT scans in patients with chronic sinusitis without nasal polyps
YARDLEY, Pa., July 08, 2022 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced additional results from the ReOpen trial program evaluating XHANCE for treatment of patients with chronic sinusitis. XHANCE® (fluticasone propionate) nasal spray is a drug-device combination product combining its proprietary Exhalation Delivery System™ (EDS™) designed to uniquely deliver drug high and deep in nasal passages with an anti-inflammatory drug. These pre-planned secondary analyses of data from the ReOpen2 trial as well as pooled data from both ReOpen1 and ReOpen2 found that patients using XHANCE in these trials experienced a spectrum of benefits on symptoms and quality of life, as well improvement in objective measures of disease, relative to patients receiving a placebo comparator.
As previously disclosed, both co-primary endpoints in ReOpen2 showed significant improvement among patients treated with XHANCE versus placebo comparator, including combined symptom score at 4 weeks and average of percentages of opacified volume (APOV) at 24 weeks. In pre-planned, exploratory, secondary analyses of ReOpen2, patients treated with XHANCE were also found to have larger improvements than patients receiving placebo comparator at the 4-week time point on each of the four individual defining symptoms of chronic rhinosinusitis, including congestion/obstruction, rhinorrhea (thick drainage), facial pain or pressure, and loss of sense of smell. Pre-planned secondary analyses also revealed greater improvement on the sinonasal outcomes test (22 item), a commonly used measure of symptoms, quality of life, and functioning in chronic rhinosinusitis, at week 24 for patients receiving XHANCE then placebo comparator. Nominal p-values for the differences between the group of patients receiving XHANCE and the group of patients receiving placebo were less than 0.05 on each of these measures.
Many people with chronic rhinosinusitis have tried and are frustrated with standard nasal steroid sprays. To inform possible differences in response of patients previously using a standard nasal steroid spray, a pre-planned analysis of pooled data from ReOpen1 and ReOpen2 assessed symptom improvement for patients entering the trials with at least moderate symptoms despite reporting use of a standard nasal steroid spray. For this subgroup, patients receiving XHANCE improved more from baseline than patients receiving placebo comparator. Additionally, a pooled analysis was performed to assess change in CT scans, measured by APOV at week 24, for the subgroup of patients receiving XHANCE who had chronic sinusitis without nasal polyps. Compared to patients treated with placebo comparator, XHANCE treatment produced greater reduction in sinus opacification in this subgroup (-6.31% vs -1.55%, nominal p-value of 0.004). Differences between active and placebo in the groups receiving one or two sprays per nostril twice daily were similar and nominally statistically significant.
“We are pleased to see new evidence from ReOpen2 suggesting XHANCE treatment produces benefits on each of the cardinal symptoms of chronic rhinosinusitis and on a measure of quality of life. Symptom relief and quality of life represent the main treatment goals for patients with chronic rhinosinusitis and their doctors,” said Ramy Mahmoud, MD, MPH, President of Optinose. “In addition, we now have pooled data showing that the subgroup of patients receiving XHANCE in the ReOpen trials who had chronic sinusitis without nasal polyps experienced improvement on the APOV endpoint.”
The safety profile and tolerability of XHANCE in these trials were consistent with its currently labelled safety profile. In pooled data from both trials inclusive of both dose groups, adverse events occurring at a rate of more than 3% in patients receiving XHANCE that were also more common than in the group receiving the EDS-placebo were epistaxis, COVID-19, nasopharyngitis, and headache.
Summary of Efficacy Results
| Difference from Placebo EDS | |||||
| Treatment | n | Baseline Score | LS Mean Changefrom Baseline | LS Mean | NominalP-value (1) |
| Change in SNOT-22 from Baseline to Week 24 (ReOpen2) | |||||
| XHANCE 186 or 372 mcg | 145 | 48.57 | -17.49 | -8.77 | 0.001 |
| Placebo EDS | 75 | 51.11 | -8.72 | - | - |
| Change in Symptoms in Prior Nasal Steroid Users from Baseline to Week 4 (Pooled) | |||||
| XHANCE 186 or 372 mcg | 172 | 5.63 | -1.46 | -0.70 | |
