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news.Meditrina Pharmaceuticals has announced the approval of its second investigational new drug application for a Phase IIb dose ranging clinical trial to study MPI-676, the company's aromatase inhibitor, in combination with estrogen and progestin for the treatment of endometriosis.
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This US-based, multi-center, placebo-controlled, double-blinded study will identify the maximally efficacious dose of MPI-676 to investigate in the pivotal Phase III program. The Phase IIb dose ranging trial will include three treatment arms of anastrozole, all with a fixed dose oral contraceptive in pre-menopausal women diagnosed with endometriosis.
The primary endpoint is reduction in endometriosis-related symptoms, primarily pain. Secondary endpoints include quality of life, bleeding patterns and safety outcomes.
The goal of the study is to provide data on efficacy and safety of MPI-676, as well as information about feasible endpoints and trial sizes for the planning and execution of the subsequent pivotal Phase III program in endometriosis.
Meditrina has recently completed a global licensing agreement to make, develop and commercialize products, including MPI-676, under AstraZeneca’s IP and know-how regarding the use of aromatase inhibitors in combination with estrogen and progestin to treat endometriosis.