XHANCE met both co-primary endpoints in the ReOpen1 trial, demonstrating statistically significant benefits on symptoms and CT scans in patients with chronic sinusitis


Optinose Reports Positive Top-line Results in ReOpen1 trial. (Credit: Chokniti Khongchum from Pixabay)

Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced that the ReOpen1 clinical trial met both of its co-primary endpoints. A statistically significant improvement was demonstrated in patients with chronic sinusitis who were treated with the XHANCE® (fluticasone propionate) Exhalation Delivery System™ in the ReOpen1 clinical trial compared to patients receiving an Exhalation Delivery System placebo as measured by both primary endpoints: first, a composite symptom score (comprising nasal congestion, facial pain or pressure, and nasal discharge) measured at week 4 and second, an objective measure of disease in the sinus cavities at week 24 (measured by average percent of the opacified volume on CT scan, summed across all of the ethmoid and maxillary sinuses).

“In ReOpen1, a large, international, controlled trial, we randomized 332 patients into the first of two trials studying XHANCE for the treatment of patients with chronic sinusitis, a disease for which there are no FDA-approved drug treatments,” said Ramy Mahmoud, MD, MPH, President of Optinose. He went on to say, “In ReOpen1 we found that patients with chronic sinusitis who used XHANCE improved, as measured by both a composite symptom score and as measured by the amount of inflammation in the sinuses themselves. ReOpen1 is exciting news for us and for tens of millions of people suffering from chronic sinusitis. Our team would like to thank the healthcare providers at our investigational sites, and especially the many patients with chronic sinusitis whose participation made this trial possible.”

The Company expects top-line results from ReOpen2, the second of its two phase 3 trials for XHANCE in chronic sinusitis, in the second quarter of 2022.

“Chronic sinusitis is a common, difficult to treat disease that causes a lot of misery. It often leads to severe sinus symptoms requiring repeated courses of antibiotics among other treatments, sometimes requiring surgery,” said James Palmer, M.D., past President of the American Rhinologic Society. “ReOpen1 is the first pivotal registration trial I am aware of that shows significant effects on both subjective and objective endpoints in this disease. In particular, there are no prior phase 3 trials that show an 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.”

The safety profile and tolerability of XHANCE in this trial were generally consistent with its currently labelled safety profile. Adverse events occurring at a rate of more than 3% with XHANCE and more common than the Exhalation Delivery System placebo group were: epistaxis, nasopharyngitis, asthma, and cataract (nuclear and cortical).

Detailed results from this trial will be submitted for publication in a peer-reviewed journal and for presentation at future medical meetings.

Source: Company Press Release