Intersect ENT's Study Of Drug-Coated Balloon For Sinus Dilation Misses Primary Endpoint
Shares of thinly-traded, small-cap medical device manufacturer Intersect ENT Inc (NASDAQ: XENT) were moving sharply lower Monday following a clinical trial readout from the company.
What Happened
Intersect ENT, which focuses on products for patients with ear, nose and throat conditions, said a study dubbed ASCEND that evaluated its drug-coated sinus balloon for dilation of the frontal sinus ostium did not meet the primary endpoint.
The benchmark was an intra-patient comparison of frontal sinus patency grade at day 30, as judged by an independent reviewer. The drug used was mometasone furoate.
The ASCEND study looked at whether the drug-coated sinus balloon would reduce post-balloon dilation edema through localized delivery directly to the dilated tissue.
"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," Boris Karanfilov, the principal investigator of the study, said in a statement.
Yet the study showed statistically significant differences in several important secondary endpoints directly attributable to the drug, such a significant reduction in inflammation and polyploid edema at all timepoints through day 30 as well as a statistically significant reduction in the need for oral steroid interventions at day 30.
The company said there were no adverse events related to the drug component of the ASCEND balloon and no device-related serious adverse events.
What's Next
Intersect ENT said the results of the trial mean that it will now have to conduct further clinical studies to support the filing of a premarket approval application with the FDA.
"We will continue to analyze the ASCEND study findings to inform our clinical and regulatory strategy. We remain committed to leading innovation with clinical evidence for the benefit of clinicians and patients with chronic sinusitis," CEO Tom West said in a statement.
Shares of Intersect ENT were sliding 15.67% to $14.31 at the time of publication.
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