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OPTN
Nasdaq Global Select Market
Item 8.01 Other Events.
The Company is reporting that it has completed previously planned, blinded interim analyses to assess the variance in the two co-primary endpoints in its second CS trial – change in Composite Score of Nasal Symptoms from baseline to week 4 and change in average percent opacification of volume by CT scan from baseline to week 24. The analyses were performed on blinded interim data from patients for whom data was available. For the Composite Score of Nasal Symptoms data was available for approximately one-half of the initial estimated enrollment of 399 patients and for the change in average percent opacification of volume by CT scan data was available for approximately one-third of the initial estimated enrollment of 399 patients. The result of these interim analyses was that the observed variance in these endpoints is 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 210 patients currently enrolled in the study. As a result, the Company has closed enrollment in this trial. For clarity, both 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 October 28, 2021, the Company issued a press release announcing the completion of patient recruitment in its second chronic sinusitis trial. 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.
