MSI completes patient recruitment for STRADA Phase 2 trial for treatment of major depressive disorder

May 7 2015

MSI Methylation Sciences, Inc., a pharmaceutical company developing a once-daily oral, small molecule therapy for adjunctive treatment of major depressive disorder (MDD), announced the completion of patient recruitment for its HORIZON Phase 2 Study. HORIZON is designed to evaluate the efficacy and safety of MSI-195 (STRADA™) in patients suffering from MDD who have had an inadequate response to current antidepressant therapy. The Horizon Study is being conducted exclusively in the US, under an IND, filed by MSI with the Food and Drug Administration, Center for Drug Evaluation and Research, Division of Psychiatry Products in 2013. The Company expects results from the HORIZON Study in late 2015.

"The HORIZON Study represents the leading edge in clinical design for a depression trial with a strong emphasis on quality. The primary objective of the HORIZON Study is to compare the change in the total Hamilton Depression Rating Scale (HAM-D17) between randomization and end of study for placebo vs. STRADA™ plus antidepressant." Said Steven D. Targum MD, Chief Medical Officer at MSI. "We are hopeful that STRADA™ will become a new treatment option for patients whose depressive symptoms have not adequately responded to their current antidepressant. Generally, treating doctors and patients prefer to use add-on therapies over switching antidepressants because it reduces the risk of relapse or of a set-back in treatment. STRADA™ has a different mechanism of action than other available antidepressants, has been reported to show good tolerability in previous clinical trials and may address the need for an effective add-on therapy."

"The completion of the enrollment of the HORIZON Study represents a milestone in the development of STRADA™ and MSI" said Barry Guld, President and Chief Executive Officer of MSI. "The World Health Organization estimates that 1 in 20 people will experience depression during their life time, with an estimated 18 million people in the US alone and over 35,000 suicides a year being reported. The estimated cost to the US economy through loss of work and increase medical expenses is estimated at over $80 billion," further shared Mr. Guld. "Even with the currently approved medications for MDD, only two thirds of the patients respond to front line therapy. We believe that there exists a large opportunity for a safe, efficacious therapy to treat depression."