Navigation Links
Metabolic Solutions Development Company announces publication of Phase 2b data in Clinical Pharmacology & Therapeutics

KALAMAZOO, Mich., Jan. 24, 2013 /PRNewswire/ -- Metabolic Solutions Development Company, LLC (MSDC) announced today the publication of data from a Phase 2b study of the company's prototype insulin sensitizer in patients diagnosed with type 2 diabetes. The data demonstrate MSDC-0160, a novel once-a-day oral insulin sensitizer and the first in a new class of therapeutic agents called mTOT Modulators™, met the study's primary endpoint of significantly reducing fasting plasma glucose (FPG) and significantly reduced hemoglobin A1c (HbA1c).

Of particular importance, the data showed that changes in body weight, hemoglobin, and an important biomarker associated with the production of white fat were significantly less in type 2 diabetic patients treated with MSDC-0160 than in patients treated with a comparator drug, pioglitazone 45 mg, a PPARg agonist. The mTOT paper is available online and is expected to be published in the print edition shortly.

The research was led by MSDC co-founder Jerry Colca , PhD, who was among the original researchers in the field of insulin sensitizers, and who selected and led the early development of Actos (pioglitazone). Dr. Colca's career-long study of the endocrine control of metabolism is the basis for MSDC's research and development of novel compounds that may treat the root causes of diabetes, insulin resistance and defects in pancreatic beta cell function.  The research has led to the discovery of a new target for insulin sensitizers.

"This data confirms our hypothesis that insulin sensitization by mTOT modulators can produce the same lowering of glucose as drugs like pioglitazone, but without the side effects caused by PPARg agonists," said Jerry Colca , PhD, president and chief scientific officer. "This prototype and its successor MSDC-0602 represent the next generation of insulin sensitizers."

MSDC's novel insulin sensitizing agents selectively modulate mTOT, a protein complex located in the inner mitochondrial that appears to coordinate carbohydrate, lipid, and amino acid metabolism. This new drug target may also play a role in other diseases of aging such as Alzheimer's disease and Parkinson's disease, as well certain genetic diseases such as polycystic kidney disease.

Phase 2 Clinical Results Support New Target Hypothesis

The publication supports MSDC researchers' long-held hypothesis that lowering of plasma glucose can be achieved without having to activate a nuclear receptor called PPARg, thus providing a new way forward for insulin sensitizers without the side effects that have prevented the development of new drugs. Previously, it was believed that both the activity and the side effects of the only approved class of drugs used to treat insulin resistance -- the core problem for persons diagnosed with type 2 diabetes -- were mediated through PPARg. These studies provide a fresh approach and a new target for new drugs to treat diabetes.

About the MSDC-0160 Phase 2b Study

This study was a 90-day, randomized, double-blind, comparator- and placebo-controlled, multi-dose study completed in 258 patients with type 2 diabetes. The study compared three doses of MSDC-0160 (50 mg, 100 mg and 150 mg) to maximum dose Actos (pioglitazone 45 mg) or placebo taken orally once daily for 12 weeks. All treatments were well tolerated. There were no serious adverse events attributed by investigators to the MSDC drug.

Key top-line data from this study include the following:

  • Both 100 mg/day and 150 mg/day of MSDC-0160 significantly lowered fasting plasma glucose (primary study endpoint).
  • Both 100 mg/day and 150 mg/day of MSDC-0160 lowered hemoglobin A1c similar to 45 mg/day pioglitazone.
  • MSDC-0160 produced significantly less volume expansion than pioglitazone at any dose.  There was a statistically significant difference between MSDC-0160 and pioglitazone in the effects the compounds had on circulating total hemoglobin and red blood cells (markers of plasma volume expansion).
  • No dose of MSDC-0160 was able to increase adiponectin as much as pioglitazone, supportive of less increase in calorie storing white adipose tissue (i.e., white fat).
  • The 100 mg dose of MSDC-0160 was effective with significantly less weight gain and no increase in waist circumference. 

About Metabolic Solutions Development Company
Metabolic Solutions Development Company ( is a drug discovery and development company investigating novel molecular targets and developing new therapeutics to treat metabolic diseases associated with age-related mitochondrial dysfunction, especially type 2 diabetes.

CONTACT: Mike Beyer , M: 312-961-2502,

SOURCE Metabolic Solutions Development Company, LLC
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Profil Institute Partners with Florida Hospital to Establish East Coast Center for Clinical Metabolic Research
2. Polaris Group Lead Therapeutic Candidate ADI-PEG 20 Demonstrates Potential Anticancer Activity in Various Metastatic Sarcomas and Bladder Cancers That Are Deficient in Key Metabolic Protein, and Enhanced Effects with Combination Therapy in Melanoma
3. Isis Pharmaceuticals Reports Positive Phase 1 Data On Three Drugs In Development To Treat Metabolic Disorders
4. SolutionStart Corp. Announces John Karagiannis as Vice President of Technology
5. Cardinal Health Specialty Solutions Launches PathWare™ Decision Support Transaction Solutions
6. At SIIM 2012 Siemens Healthcare Demonstrates Departmental IT Solutions That Help Administrators Increase Access while Managing Costs
7. Cardiosolutions, Inc. Receives FDA 510(k) Clearance for Dexterity™ Steerable Introducer
8. UBM Canon, the Global MedTech Authority, Partners with the World Medical Device Organization, WMDO, to Provide Medical Device Companies with Industry-Related Online Training Solutions
9. Ablative Solutions Completes $5.3M Series A Financing
10. DATATRAK Expands CDISC Registered Solutions Provider Standards
11. MedNet Solutions to Unveil Innovative New iMedNet EDC Features at The 48th DIA Annual Meeting
Post Your Comments:
(Date:11/25/2015)... , Nov. 25, 2015  Linden Care, LLC, ... optimizing treatment outcomes for patients suffering from chronic pain, ... for a Temporary Restraining Order (TRO) enjoining Express Scripts ... two companies. --> --> ... all of its legal options. --> ...
(Date:11/25/2015)... 25, 2015 On Tuesday, November 24, ... trial against Wright Medical Technology, Inc. for product ... metal-on-metal hip implant device, awarded $11 million in ... week trial and three days of deliberations, the ... was defectively designed and unreasonably dangerous, and that ...
(Date:11/25/2015)... , Nov. 25, 2015  Henry Schein, Inc., ... services to office-based dental, medical and animal health practitioners, ... Meeting the Henry Schein ConnectDental® Pavilion , which ... array of open solutions designed to help any practice ... Click here for a schedule of experts appearing ...
Breaking Medicine Technology:
(Date:11/25/2015)... CA (PRWEB) , ... November 25, 2015 , ... According ... Vinci surgical robot is being more and more widely heralded as a breakthrough for ... da Vinci method has over traditional laparoscopic surgery is that it can greatly reduce ...
(Date:11/25/2015)... Boca Raton, Florida (PRWEB) , ... November 25, ... ... on-site diagnostic testing for physicians and athletic programs, launches new Wimbledon Athletics ... the importance of testing young athletes for unsuspected cardiac abnormalities. About 2,000 people ...
(Date:11/25/2015)... (PRWEB) , ... November 25, 2015 , ... ... a double board certified facial plastic surgeon specializing in both surgical and non-surgical ... of The Skin Spa at Hobgood Facial Plastic Surgery. , Highly trained ...
(Date:11/25/2015)... , ... November 25, 2015 , ... “While riding the ... inventor, from Bronx, N.Y. “I thought there had to be a convenient and comfortable ... PROTECTOR. , The PROTECTOR enables disabled individuals to safely travel during cold or inclement ...
(Date:11/25/2015)... ... 25, 2015 , ... "When I underwent breast reconstruction following ... uncomfortable," said an inventor from Bronx, N.Y. "In order to meet my own ... BRA for added comfort and support. The bra is easier to put on ...
Breaking Medicine News(10 mins):