MENLO PARK, Calif.—Intersect ENT, Inc. has announced results from a study of the company’s ASCEND investigational drug-coated sinus balloon.
The ASCEND study is the first prospective, randomized, double-blind, multi-center trial designed to assess the safety and efficacy of Intersect ENT’s drug-coated sinus balloon for dilation of the frontal sinus ostium. The investigational product was randomized against an uncoated balloon control to evaluate whether it would reduce post-balloon dilation edema by delivering localized steroids directly to the dilated tissue.
The primary endpoint was an intra-patient comparison of frontal sinus patency grade at day 30, as judged by an independent reviewer. Secondary endpoints were included to assess post-dilation inflammation, polypoid edema, scarring and the need for interventions like oral steroids. As this is the first trial of its kind for this product platform, Intersect ENT recognizes that the outcomes of the ASCEND trial could require further clinical study in order to support premarket approval with the U.S. Food and Drug Administration.
“The ASCEND trial gives us valuable insight into the performance of our novel drug-coated balloon, enabling us to refine our clinical and regulatory pathway. We are obviously disappointed that this initial trial did not demonstrate superiority in its primary endpoint. However, as in our prior clinical research with drug-eluting implants, we again observed benefits of providing localized drug delivery of mometasone furoate through combined drug-device offerings. We will continue to analyze the ASCEND study findings to inform our clinical and regulatory strategy,” said Tom West, president and CEO of Intersect ENT.
The trial didn’t meet its primary endpoint of frontal sinus patency grade at day 30, as judged by an independent reviewer. But the ASCEND drug-coated balloon did show statistically significant differences in several important secondary endpoints directly attributable to the drug, mometasone furoate. These endpoints included statistically significant reduction in inflammation and polypoid edema at all timepoints through day 30, as assessed by both clinical investigators and independent reviewer.
“An initial observation worth noting from the results of this study is the trend for the mometasone furoate to significantly minimize inflammation and edema at the site of dilation when delivered with the ASCEND drug-coated balloon as compared to the uncoated balloon,” added Boris Karanfilov, M.D., director of the Ohio Sinus Institute, who served as national principal investigator of the study. “We look forward to assessing the results of the study more extensively with our fellow clinical investigators and Intersect ENT.”
There was also a statistically significant reduction in the need for oral steroid interventions at day 30, determined the independent reviewer. There were no adverse events related to the drug component of the ASCEND balloon, and no device-related serious adverse events observed in the study.