![]() The total target number of subjects was 162 however, due to high interest in the study, a total of 194 subjects were enrolled in this study across 29 sites in 11 countries worldwide. The study was a multi-center, randomized, double-masked, and placebo-controlled phase 3 clinical study in which subjects were randomly assigned to emixustat 10 mg or placebo (2:1 ratio) once daily for 24 months. This analysis determined that emixustat treatment resulted in a 40.8% reduction in lesion progression compared to placebo at Month 24 (p=0.0206, emixustat n=34, placebo n=21). A multi-factor analysis was performed on the subgroup of subjects with smaller lesions at baseline, controlling for the baseline factors identified in univariate and multi-factor analyses to affect lesion progression in this subgroup. Prompted by planned subgroup analyses suggesting that emixustat subjects with smaller atrophic lesions at baseline had a reduced rate of progression compared to placebo subjects, post hoc analyses were performed to further investigate this finding. Previously announced top-line results showed that the study did not achieve its pre-planned primary or secondary endpoints. The primary objective of this study was to determine if emixustat reduces the rate of macular atrophy progression, in comparison to placebo, in subjects with Stargardt disease. (Tokyo 4596), announced today positive results from a post hoc analysis of the phase 3 clinical trial of the investigational visual cycle modulator emixustat hydrochloride (emixustat) in patients with Stargardt Disease. (“Kubota Vision”), a clinical-stage ophthalmology company and wholly-owned subsidiary of Kubota Pharmaceutical Holdings Co., Ltd. SEATTLE-( BUSINESS WIRE)-Kubota Vision Inc. ![]()
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