VANCOUVER, May 7, 2015 /PRNewswire/ - 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."
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), 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 ("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.
SOURCE MSI Methylation Sciences Inc.