Four and a half years after Optinose first went public with its promise to create a franchise for its nasal spray, Optinose says it has important Phase III data to finally move forward.
A Yardley, Pennsylvania-based biotech company reports positive results from ReOpen1, suggesting that patients with chronic sinusitis will improve after using XHANCE, a “breathing” device that delivers a corticosteroid called fluticasone.
A short-lived 25% spike in the stock price quickly turned into more moderate gains, and $OPTN stock rose 1.84% to $2.77.
Without disclosing numbers, Optinose said the study, which included a total of 332 patients, met both primary endpoints compared to placebo. First measured symptoms on a combined scale of nasal congestion, facial pain or pressure and nasal discharge at the end of the fourth week; the second tracked the change from baseline up to week 24 in the percentage of ethmoid and maxillary sinus volume occupied by disease as measured by computed tomography.
While XHANCE is already approved for people with nasal polyps, Optinose has long suggested that chronic sinusitis — the type of nasal congestion and discharge that occurs without nasal polyps — is a much larger, yet untapped market.
Roughly 1 million patients in the US have been diagnosed with nasal polyps, CEO Peter Miller said last November. In contrast, Optinose estimates that about 30 million Americans are living with chronic sinusitis and there are no FDA-approved treatments for them.
The chronic sinusitis label expansion will expand the target patient population for which our sales team can promote XHANCE as an appropriate treatment from approximately 1 million patients to approximately 3 million patients diagnosed and treated by the physicians we target today. In addition, the partner can leverage its expanded presence in primary care to expand XHANCE’s promotion to the 30 million people in the US with chronic sinusitis.
According to the researchers, the most common side effects were nosebleeds, nasopharyngitis, asthma, and cataracts (nuclear and cortical).
The second key trial is ongoing and Optinose expects major results in the second quarter.