Optinose has chalked up a win for its exhalation delivery system in chronic sinusitis patients in a phase 3 clinical trial. Using the system to deliver fluticasone propionate sparked improvements in symptoms and an objective measure of disease in the sinus cavities, causing the study to hit its co-primary endpoints.
GlaxoWellcome won FDA approval for Flonase, a nasal spray formulation of the corticosteroid fluticasone propionate, in the 1990s. The allergy relief product is now available over the counter, but there remains an unmet medical need in chronic sinusitis, a condition defined by the inflammation of the sinuses for three months or more despite treatment.
Optinose wants to address the need using its exhalation system to deliver fluticasone propionate. With phase 3 data now in hand, Optinose has the strongest evidence yet that its approach improves outcomes in the indication by enabling broader, more consistent drug delivery to the nasal passages.
The phase 3 randomized 332 chronic sinusitis patients with or without nasal polyps to receive placebo or one of two doses of the fluticasone propionate formulation, which is branded Xhance, twice daily. At the end of Week 4, the mean reduction on a combined symptom score in the Xhance arms was around 1.6, compared to a 0.62 decline in the control cohort.
Optinose also reported a statistically significant improvement in sinus opacification in the two treatment arms. At Week 24, the sinus volume occupied by disease as measured by CT scan had fallen by 5.6% to 6.2% in the low- and high-dose Xhance arms, respectively, versus a 1.6% reduction in the control group.
Five types of adverse event occurred in more than 3% of recipients of Xhance and were more common in the treatment arms than the control group. The most common, at 12%, was nosebleeds in recipients of the high dose of Xhance. Optinose said the safety and tolerability results were “generally consistent” with the label of Xhance, which is already approved in the treatment of nasal polyps.
Optinose is now working to deliver data from a second clinical trial. Enrollment in the study wrapped up in October, putting Optinose on course to release top-line results in the second quarter.