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VANCOUVER, BRITISH COLUMBIA--(Marketwired - Jan 27, 2016) - MSI Methylation Sciences Inc., a pharmaceutical company developing oral, small molecule therapies for major depressive disorder (MDD), announced the results of its first Phase 2 clinical trial designed to evaluate the efficacy and safety of MSI-195 (Strada™) relative to placebo added to ongoing antidepressant therapy, in patients suffering from MDD who have had an inadequate response to current antidepressant therapy.
MSI-195 did not demonstrate efficacy over placebo for the primary endpoint. While the topline results were disappointing, post-hoc exploratory analysis identified a number of key factors associated with beneficial treatment differences for MSI-195 vs. Placebo. For example, a large responsive patient sub-group was identified when patients with high BMI (>40) and unstable symptom profiles were excluded. This analysis with 143 patients (74 on MSI-195 and 69 on placebo) showed the MSI-195 treated group achieved a clinically significant reduction in Montgomery-Asberg Depression Rating Scale (MADRS) of -3.41 (p value 0.031) relative to placebo (LOCF-ITT analysis) with an effect size of 0.36.
Additionally, MSI-195 was well tolerated. No serious adverse events were recorded during the trial. The overall adverse event profile for MSI-195 was as expected with the most frequently reported adverse events being gastrointestinal disorders. All other treatment emergent adverse events showed no difference between placebo and drug arms.
"While we did not meet our primary endpoint, we are encouraged to see, within our exploratory analysis, robust support for clinically significant efficacy in a large subset of patients. We believe the HORIZON study was a well conducted trial and very informative in planning our future studies," said Barry Guld, co-founder & CEO at MSI. "Given the safety and clear direction provided through exploratory efficacy analysis in our first trial, our focus will be on future clinical development of MSI-195."
About the HORIZON Trial
The HORIZON trial was a US, double-blind, randomized, placebo-controlled, Phase 2, add-on clinical trial investigating the ability of MSI-195 plus current anti-depressant therapy to decrease depressive symptoms based on the Hamilton Depression Rating Scale (HAMD-17) and Montgomery-Asberg Depression Rating Scale (MADRS), with Major Depressive Disorder (MDD) patients who have had an inadequate response to current anti-depressant therapy. This trial focused on MDD patients who have failed to respond to anti-depressant therapy for at least 6 weeks. The trial was designed to measure safety and efficacy over an 8 week period.
For more information on the HORIZON Study, please visit www.clinicaltrials.gov.
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 MSI Methylation Sciences Inc.
Methylation Sciences ("MSI" or the "Company") 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, Strada™, 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.