Download New Hope for the Treatment and Prevention of Age

New Hope for the Treatment and Prevention of Age-Related Metabolic Diseases
Vision
FOCUS
Metabolic diseases associated
with age-related mitochondrial
dysfunction, especially insulin resistance and type 2 diabetes.
DEVELOPMENT STATUS
Developing novel insulin sensitizers that are selective for a newly
identified molecular target connecting mitochondrial metabolism
to important cellular activities that
are out of balance in metabolic
diseases. Phase 2 clinical proof of
concept has been demonstrated.
INTELLECTUAL PROPERTY
Composition of matter, use, and
process patents issued and pending.
FUNDING STATUS
Raised $55 million since 2006.
Raising a $40 million Series E
round to conduct Phase 2b study
of MSDC-0602 and advance the
mTOT Modulator new chemical
entity pipeline to Phase 2.
CONTACT
Stephen C. Benoit, CEO
Metabolic Solutions
Development Co., LLC
Kalamazoo, Michigan
(269) 903.0430
[email protected]
www.msdrx.com
Metabolic Solutions Development Company, LLC (MSDC) believes that diabetes
can and should be prevented. The pioneering insights of the company’s founders
into the pharmacology of insulin sensitizers has driven MSDC to the forefront of
the field with the breakthrough discovery of a new mitochondrial molecular target,
mTOT™, and subsequent development of a novel class of insulin sensitizers already in clinical trials called mTOT Modulators ™.
Mission
MSDC is a drug discovery and development company investigating new molecular
targets and developing novel therapeutics to treat metabolic diseases associated
with age-related mitochondrial dysfunction, especially insulin resistance and type 2
diabetes. The company’s lead products, MSDC-0160 and MSDC-0602, are the
first anti-diabetic agents in a new class of insulin sensitizers referred to as mTOT
Modulators for the treatment of type 2 diabetes.
The Company was founded in 2006 by Jerry Colca, PhD and Rolf Kletzien, PhD,
former researchers at The Upjohn Company who were key players in the early
development of insulin sensitizers for type 2 diabetes mellitus (T2DM) and who
helped select and led the development of Actos® (pioglitazone hydrochloride).
Insulin Sensitizers
Insulin sensitizers were discovered more than 25 years ago. After more than 12
years of clinical use, they have been shown to provide durable therapeutic effects
in the treatment of diabetes. More than a decade after the first insulin sensitizers
were discovered, a hypothesis was developed that activation of the PPAR was
the mechanism of action by which these agents improved insulin sensitivity. However, as has been reported widely in the literature, PPAR is now recognized to be
responsible for the dose-limiting effects associated with currently marketed insulin
sensitizers, and these adverse actions are, in fact, off-target effects.
In 2010, MSDC scientists made the breakthrough discovery that identified a new
mitochondrial target, mTOT, as the target through which insulin sensitizers produce their anti-diabetic effects. As a result of this new understanding, and as
demonstrated in multiple clinical studies in patients diagnosed with type 2 diabetes, MSDC and its collaborators are demonstrating that mTOT is the molecular
complex through which insulin sensitization is achieved.
Pipeline
MSDC (cont’d)
MSDC-0160
A 90-day, randomized, double-blind, comparator- and placebo-controlled, multidose Phase 2b clinical study in 258 patients with type 2 diabetes was completed
in December 2011. Data from this study was presented at the American Diabetes Association 72nd Scientific Sessions in June 2012 (Abstract 966-P).
MSDC-0160 also is being studied at Rush University Medical Center (Chicago)
in a Phase 2a trial in patients with dementia due to Alzheimer’s disease, with
funding provided by the Alzheimer’s Drug Discovery Foundation. In addition, the
compound is being investigated in animal models of polycystic kidney disease in
collaboration with the Polycystic Kidney Disease Foundation.
MSDC-0602
A 28-day, randomized, double-blind, comparator- and placebo-controlled, multidose Phase 2a study in 129 patients with type 2 diabetes completed in August
2011. This proof-of-concept clinical study showed that MSDC-0602 achieved
significant glucose control and increased insulin sensitivity in type 2 diabetes
patients. A Phase 2b study is expected to begin Q3 2012.
MSDC-0602 also is being evaluated in animal models of fatty liver disease (FLD)
supported by a grant from the National Institute on Alcohol Abuse and Alcoholism of the National Institutes of Health.
FOUNDERS
Jerry Colca, PhD
Rolf Kletzien, PhD
BOARD OF DIRECTORS
Stephen Benoit (CEO)
Jerry Callahan, PhD, MBA (Hopen
Life Science Ventures)
Jerry Colca, PhD (President/CSO)
Michael Jandernoa (Co-Founder,
Bridge Street Capital Partners and
Founder, Grand Angels)
Rolf Kletzien, PhD (Sr. VP Research)
John Landis, PhD (Adjunct Professor, Purdue Univ. )
Mark Olesnavage, Board Chair
(Hopen Life Science Ventures)
William Parfet (Chairman and
CEO, MPI Research)
SCIENCE & MEDICAL
ADVISORY BOARD
IDF Diabetes Atlas, 5th ed. © International Diabetes Federation, 2011.
Market
As highlighted by the International Diabetes Federation Atlas (5th Ed.), diabetes
is a significant and growing problem, and the costs to society are high and escalating. In particular, the IDF report noted that the number of people with type 2
diabetes is increasing in every country. Only the class of drugs referred to as
insulin sensitizers treat the root cause of type 2 diabetes – insulin resistance.
Thus, there is a critical unmet need for new therapeutic agents that improve insulin sensitivity.
According to the American Diabetes Association and the U.S. Centers for Disease Control, 25.8 million children and adults in the United States – 8.3% of the
population – have diabetes. There are an additional 79 million people in the U.S.
with pre-diabetes.
William Baer, MD, PharmD
(Executive Director and CMO,
ClinXus)
Charles Burant, MD, PhD (Dr.
Robert C. and Veronica Atkins
Professor of Metabolism, University of Michigan Medical School)
Barbara Cannon, PhD (Professor
of Physiology, Wenner-Gren Institute, Stockholm University )
Douglas Morton Jr., PhD (former
Group VP, Technology Acquisitions Operations, Pfizer)
June 2012