August 25, 2015 – MSI Methylation Sciences Inc. (MSI)
VANCOUVER, B.C., August 25, 2015 (PRNewswire Service) – MSI Methylation Sciences Inc., a pharmaceutical company developing a once-daily oral, small molecule therapy for adjunctive treatment of major depressive disorder (MDD), announced today the treatment of the last patient in its HORIZON Phase 2 study. The HORIZON Study is designed to evaluate the efficacy and safety of 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 early Q4 2015.
“The completion of the treatment phase of the HORIZON Study represents a major milestone in the development of Strada™ and MSI” said Barry Guld, President and Chief Executive Officer of MSI. “The World Health Organization estimates that roughly 5% of the World’s population will experience depression during their life time. Depression represents the largest loss of work and medical costs, estimated at over $80 billion. We believe that Strada™ is a generally well-tolerated and efficacious drug candidate to treat depression.”
Unlike most currently approved antidepressants, which act on serotonin and related neurotransmitter pathways in the brain, Strada™ is acting through a different mechanism of action in the treatment of depression. One possibility is the mediation of cytokine effects on the CNS which may play a role in changing the pathophysiology of the disease.
“The currently marketed antidepressants all work through similar pathways in the brain and do not adequately treat almost half of individuals with major depression.” said Dr. Steven Targum, Chief Medical Officer of MSI. “This represents a large problem. New medicines that work in different ways represent tools for both doctors and patients in the treatment of people who inadequately respond to marketed antidepressants. We look forward to evaluating the data from our HORIZON trial.”
MSI also announced today that European Patent EP 2464358 was issued by the European Patent Office on June 17, 2015. This patent along with patents that have issued in the US and in Europe add to the intellectual property surrounding MSI’s lead anti-depressant drug, Strada™.
Four patents have been issued within the last year to MSI: US Patent 8,975,238 (issued March 10/15), European Patent EP 2753336 (issued May 6/15), US Patent 8,865,203 (issued October 21/14) and European Patent EP 2464358 (issued June 17/15).
“We are pleased to receive these patents which increase the depth of intellectual property protection for Strada™ in the United States and expand the protection across Europe,” said Barry Guld, “The patents cover key composition features of Strada™ as well as the unique pharmacokinetic profiles engendered by MSI’s novel formulation techniques. This intellectual property provides a long patent life for our product, extending into late 2033”.
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 Strada™ plus current anti-depressant therapy to decrease depressive symptoms based on the Hamilton Depression Rating Scale (HAM-D17). The study has 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 had an inadequate response 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.
MSI Methylation Sciences Inc. (“MSI” or the “Company”) is focused on developing new products based on molecules which have clinical proof of concept but which have yet to be exploited in the major pharmaceutical markets. The first product is based on S-adenosylmethionine (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. The Company has a broad intellectual property portfolio and pipeline of candidates.
For more information, please visit www.methylationsciences.com