Santen Inc
NAPA, CA (JUNE 20, 2011)--Santen Inc., announced the initiation of a global Phase 3 clinical study evaluating its investigational drug sirolimus (DE‐109) for the treatment of noninfectious posterior uveitis.
Sirolimus, originally known as rapamycin, is a highly potent, broad‐acting compound that has been demonstrated to combat disease through multiple mechanisms of action. It is known to be an immunosuppressive and anti-proliferative agent in humans and an anti‐angiogenic, anti-migratory, anti-fibrotic, and anti‐permeability agent in animal models.
The Phase 3 study, SAKURA (Study Assessing double‐masked Uveitis treatment), opened enrollment in May. It is a multinational, multicenter, randomized, double‐ masked study assessing the safety and efficacy of three different doses of sirolimus. The doses will be administered every two months in subjects with active, non-infectious uveitis of the posterior segment of the eye.
Approximately 500 subjects with active, non-infectious posterior, intermediate or panuveitis will be enrolled at approximately 150 sites. Eligible subjects will be randomized into three arms each receiving different doses of DE‐109 by intravitreal injection.
The primary endpoint, the proportion of subjects with a vitreous haze score of zero (Standardized Uveitis Nomenclature [SUN] Photographic scale) will be assessed at month five and subjects will be followed for an additional seven months for safety evaluation.
"We are thrilled about the initiation of the SAKURA study, as the biggest thing that the program addresses is a major unmet need in the posterior uveitis space," said Naveed Shams, MD, PhD, Head of Global Clinical Development and Medical Affairs in the Santen Global Research & Development Division. "If proven to be clinically effective, it should significantly impact the quality of life of patients with non‐infectious, posterior uveitis. Intravitreal sirolimus is expected to significantly reduce the use of systemic and local corticosteroids to treat noninfectious
posterior uveitis and hence reduce the incidence of corticosteroid‐induced co-morbidities."
Initiation of the SAKURA study is in line with Santen's desire to expand its presence worldwide and to develop and market innovative new products that address unmet medical needs in the dry eye, vitreo‐retinal and glaucoma therapeutic segments.