However, the analysis of the unblinded primary endpoint data did not show the required level of statistical significance when comparing the SinuNase arm to the control arm. The unblinded intent-to-treat statistical analysis using the O’Brien composite ranking showed a p-value = 0.14 comparing SinuNase lavage to the control lavage. The company continues to believe that SinuNase is a viable product candidate for the treatment of chronic sinusitis (CS), and a full data analysis of both the primary and secondary endpoints will be conducted in order to determine the next steps necessary in order to advance the product, both in its lavage and pump-spray formulations.
The safety profile of SinuNase lavage was comparable to the safety profile of the control lavage without a single serious adverse event attributable to SinuNase or any example of allergic reaction to SinuNase despite over 20,000 dose exposures. The results for the primary endpoint show a superiority of SinuNase lavage over control lavage. Moreover, all of the patients enrolled in the study had their nasal mucus test positive for eMBP (eosinophilic major basic protein positive). Of the 299 enrolled, 299 tested positive for eMBP, strongly supporting the role of eosinophilic reaction to fungi in the pathogenesis of CS.
The company expects to have the full data set in April, and believes it is possible that this data may provide additional evidence among responders for superiority of intranasal antifungal lavage compared to the control lavage in terms of lessening of severity of symptoms in CS, reduction in polyposis by endoscopy, reduction in sinus inflammation by CT scan, and more substantial reduction in molecular markers of fungus and inflammation in the nasal mucus. The full data set may also help to predict if a low volume pump spray of SinuNase is likely to show superiority to placebo control by eliminating any therapeutic benefits which appear to be intrinsically associated with a lavage.