OPTN - Optinose nasal spray Xhance beats placebo in pooled data from trials in sinusitis patients

Optinose ( NASDAQ: OPTN ) said a pooled analysis of two Phase 3 trials showed that its nasal spray Xhance showed benefit over placebo in patients with chronic sinusitis.

The company had previously reported data from the studies, ReOpen1 and ReOpen2 , and was now released data of multiple secondary goals from ReOpen2 and a pooled analysis from the two trials, which checked symptom improvement in patients entering the trials with at least moderate symptoms despite use of a standard nasal steroid spray.

Xhance — which is an FDA-approved therapy for nasal polyps — is a drug-device to deliver topical anti-inflammatory corticosteroid to nasal cavities. It was evaluated against an Exhalation Delivery System (EDS)-placebo.

Optinose said that a secondary analyses of ReOpen2 showed that patients treated with Xhance had larger improvements than patients on placebo comparator at 4-weeks in symptoms of chronic rhinosinusitis, including congestion/obstruction, rhinorrhea (thick drainage), facial pain or pressure, and loss of sense of smell. Xhance also showed greater improvement than placebo, on a test measuring symptoms, quality of life, and functioning.

The company added that a pooled analysis of the two studies showed that patients receiving Xhance improved more from baseline than patients receiving placebo.

In addition, in a subgroup of patients without without nasal polyps, Xhance showed a greater reduction in sinus opacification, compared to placebo on CT scans.

"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," said Optinose ( OPTN ) President Ramy Mahmoud.

The company added that the differences between active and placebo in the groups receiving one or two sprays per nostril twice daily were similar and nominally statistically significant.

In the pooled data, adverse events occurring at a rate of more than 3% in patients on Xhance, which was more common than in those receiving EDS-placebo, were nose bleeding, COVID-19, common cold, and headache.

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