Kubota Pharmaceutical Holdings Co., Ltd.
Positive post-hoc analysis presented for Phase 3 clinical trial Emixustat hydrochloride, a drug candidate for the treatment of Stargardt’s disease
Kubota Pharmaceutical Holdings Co., Ltd. (Headquarters: Chiyoda-ku, Tokyo, hereinafter “the Company”) has announced that it will launch “Emixustat Hydrochloride” (hereinafter “Emixustat”) implemented by Kubota Vision Inc. (Headquarters: Washington, USA), a wholly owned subsidiary of the Company. ) for the indication of Stargardt’s disease.
The primary endpoint of this clinical trial includes verification of the efficacy in suppressing the progression of macular atrophy lesions in patients with juvenile macular degeneration Stargardt’s disease. There were no results demonstrating statistical significance for the emixustat-treated group compared with Subsequent further analysis suggested a significantly lower rate of progression of atrophic lesions in the emixustat group compared to placebo in the group of subjects with smaller baseline atrophic lesion area (mm2). , we conducted a subgroup analysis (*1) to verify this. We performed univariate and multivariate analyzes by attrition on the group of subjects with small baseline atrophic lesion area to identify independent baseline factors influencing the progression of atrophic lesions in this subgroup. The analysis showed that the progression rate of macular atrophy at 24 months in the emixustat group was 40.8% compared to the placebo group.
%reduced (p=0.0206, emixustat n=34, placebo n=21).
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