Meditrina is evaluating MPI-676 in endometriosis. A US-based, multi-center, placebo-controlled, double-blinded study is in preparation to identify the minimal 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 about the 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 is evaluating also MPI-674 as an oral drug that can be administered a for a short time prior to the endometrial ablation. A US-based, multi-center, placebo-controlled phase II clinical trial has been completed in premenopausal women with the primary objective of evaluating the appropriate time during the menstrual cycle to initiate dosing to either induce or maintain a thin endometrium (protocol M001). With dose timing data from this trial, Meditrina will progress to a subsequent phase II dose ranging trial (protocol M002) followed by a pivotal phase III trial (M003).
In the future, Meditrina plans to seek additional indications for its proprietary drug candidates that will further improve treatment options for women suffering from health disorders with serious unmet needs such as ectopic pregnancy, endometriosis and uterine fibroids.