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Item 8.01 Other Events.
As previously reported, the Company completed an interim analysis to access the variance in one of the two co-primary endpoints in its first CS trial - change in Composite Score of Nasal Symptoms from baseline to week 4. The analysis was performed on blinded interim data from approximately half of the initial estimated enrollment of 378 patients. The result of this interim analysis was that the observed variance in this endpoint was lower than the variance assumed when the Company estimated sample size during the design of the study.
The Company is now reporting that it has completed a previously planned, blinded interim analysis to access the variance in the other co-primary endpoint in this trial – change in average percent opacification of volume by CT scan from baseline to week 24. The analysis was performed on blinded interim data from approximately one-third of the initial estimated enrollment of 378 patients for whom 6-month CT scan data was available. The result of this interim analysis was that the observed variance in this endpoint was also lower than the variance assumed when the Company estimated sample size for statistical powering during the initial design of the study. Based on the results of these two interim analyses, and the Company’s assumptions and estimates relating to the study, the Company anticipates that the initial targeted statistical power will be achieved with the approximately 330 patients currently enrolled in the study. As a result, the Company has closed enrollment in the first CS trial and is now focusing all of its recruitment efforts on the second CS trial. For clarity, both of the referenced interim analyses were blinded to treatment group and therefore could not evaluate the magnitude of difference, if any, between treatment groups. Accordingly, these interim analyses were not designed to, and do not, provide evidence regarding possible superiority of active treatment over placebo or success of the trials.
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On July 30, 2021, the Company issued a press release announcing the completion of patient recruitment in one of its chronic sinusitis trials. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.
