(MSI) Completes Recruitment of Phase 2 Trial for its Novel Treatment STRADAâ„¢ for Major Depressive Disorder (MDD)
May 07, 2015 – MSI Methylation Sciences, Inc.
VANCOUVER, BC. – 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 (STRADAâ„¢) 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.
â€œThe 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. STRADAâ„¢ plus antidepressant.â€ Said Steven D. Targum MD, Chief Medical Officer at MSI. â€œWe are hopeful that STRADAâ„¢ 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. STRADAâ„¢ 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.â€
â€œThe completion of the enrollment of the HORIZON Study represents a milestone in the development of STRADAâ„¢ and MSIâ€ said Barry Guld, President and Chief Executive Officer of MSI. â€œThe 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,â€ further shared Mr. Guld. â€œEven 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.â€
About Major Depressive Disorder (MDD)
Major depressive disorder (MDD) is a condition in which patients exhibit depressive symptoms, such as a depressed mood or a loss of interest or pleasure in daily activities consistently for at least a two-week period, and demonstrate impaired social, occupational, educational or other important functioning. Depression is the leading cause of disability in the US and in other major market economies.
About the HORIZON Trial
The HORIZON trial is a US, double-blind, randomized, placebo-controlled, Phase 2, add-on clinical trial investigating the ability of STRADAâ„¢ plus current anti-depressant therapy to decrease depressive symptoms based on the Hamilton Depression Rating Scale (HAM-D17), with over 300 patients enrolled with Major Depressive Disorder(MDD) who have had an inadequate response to current anti-depressant therapy. This trial focuses on MDD patients who have failed to respond to anti-depressant therapy for at least 6 weeks. The trial is designed to measure safety and efficacy over an 8 week period.
For more information on the HORIZON Study, please visit: www.clinicaltrials.gov.
About MSI Methylation Sciences Inc.
Methylation Sciences (â€œMSIâ€ or the â€œCompanyâ€) is focused on developing new products based on molecules which have clinical proof of concept but have yet to be exploited in the major pharmaceutical markets. The Company’s first product, STRADAâ„¢, is based on S-adenosyl methionine, a naturally occurring molecule produced throughout the body, where it plays a vital role in the one-carbon cycle. The Company has developed superior oral formulations of this molecule with STRADA being the first in clinical development. MSI has a broad intellectual property portfolio and pipeline of candidates.
For more information, please visit: www.methylationsciences.com.
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