Accentia Biopharmaceuticals (ABPI) Announces SinuNase Fast-Tracked Pivotal Phase 3 Study in Chronic Sinusitis Shows Statistically Significant
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Accentia Biopharmaceuticals, Inc. (NASDAQ: ABPI) announced that continued analysis of the unblinded full data set on its pivotal Fast-Tracked Phase 3 Trial of SinuNase™ (topical amphotericin B 0.01% suspension) for chronic sinusitis has demonstrated that among patients with objective evidence of more intense inflammation in chronic sinusitis at the time of enrollment, the efficacy of SinuNase compared to control lavage in reducing inflammation is statistically significant.
In particular, among those patients who started the trial with more severe nasal inflammation causing greater polyposis and more severe sinus inflammation causing greater mucosal thickening on CT scan at enrollment, patients in the SinuNase arm of the study achieved a statistically significant reduction in fungal-induced inflammation as judged by a reduction in eMBP in the mucus and nasal polyposis reduction (p-value = 0.03).
Furthermore, the analysis of the full data set has shown that the subjective primary endpoint of complete resolution of the cardinal symptoms of sinus headache and nasal congestion as reported by study participants at the conclusion of the 16 week trial is not reliable. In particular, almost 50% of patients who reported complete resolution of both cardinal symptoms nevertheless scored one or both of these symptoms as having a severity of greater than zero on a symptom severity scale being validated during the clinical trial. Accordingly, the Company cautions that the lack of a statistically significant superiority of SinuNase versus control lavage on this subjective primary endpoint should not be used to infer that SinuNase lacks efficacy.
Based on ongoing analyses of the full data set, the Company is formulating its go-forward strategy with respect to SinuNase regulatory approval and commercialization. At this time, the Company intends to pursue development of the SinuNase lavage for severe cases of inflammation. [SM]
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