Nasal spray maker clinches first PhIII win it needs to reach a much, much bigger market
Four and a half years after first going public on the promise of building out a franchise for its nasal spray, Optinose says it has the landmark Phase III data to finally move forward.
The Yardley, PA-based biotech is reporting positive topline results from ReOpen1, suggesting that patients with chronic sinusitis would improve after using XHANCE, an “exhalation” device that delivers a corticosteroid named fluticasone.
A brief surge in the stock price as high as 25% quickly gave way to more tempered growth, and shares $OPTN are up 1.84% to $2.77.
Without breaking out the numbers, Optinose said the trial, which enrolled a total of 332 patients, met both co-primary endpoints compared to placebo. The first measured symptoms by a composite score of nasal congestion, facial pain or pressure sensation and nasal discharge at the end of week four; the second tracked the change from baseline to week 24 in percent of ethmoid and maxillary sinus volume occupied disease, as measured by CT scan.
While XHANCE is already approved for people with nasal polyps, Optinose has long suggested that chronic sinusitis — the kind of nasal congestion and discharge that occurs without nasal polyps — represents a much bigger, and yet unreached, market.
Approximately 1 million patients in the US are diagnosed with nasal polyps, CEO Peter Miller said last November. By contrast, Optinose estimates around 30 million Americans live with chronic sinusitis — and there are no FDA-approved treatments for them.
A label expansion for chronic sinusitis will expand the target patient population for which our specialty-focused sales force can promote XHANCE as an appropriate treatment from approximately 1 million patients to approximately 3 million patients diagnosed and treated by the physicians that we target today. In addition, there is potential for a partner to leverage their deployed presence in primary care to expand promotion of XHANCE to a total of up to 30 million people in the U.S. who have chronic sinusitis.
According to investigators, the most common side effects were nose bleeds, nasopharyngitis, asthma and cataract (nuclear and cortical).
A second pivotal trial is ongoing and Optinose expects topline results in the second quarter.