LA CHAUX-DE-FONDS, Switzerland, Feb. 11, 2014 /CNW/ - Kareus Therapeutics SA ("Kareus") announced today that US FDA has approved its Investigational New Drug (IND) KU-5039 to initiate Phase I clinical trial. KU 5039 is being developed for the treatment of insulin resistance and diabetes.
KU-5039 is an orally active, New Chemical Entity (NCE), discovered and developed by Kareus. KU-5039 is a potent and selective activator of AMP-kinase (AMPK), a key regulator of cellular and whole body energy homeostasis that coordinates metabolic pathways. Pharmacological activation of AMPK in animals promotes glucose uptake, fatty acid oxidation, mitochondrial biogenesis, and insulin sensitivity.
KU-5039 has shown therapeutic potential in treatment of insulin resistance and diabetes in animal models. KU-5039 will commence First in Human trials to evaluate safety, tolerability and pharmacokinetics profile in a randomized, double-blind, placebo-controlled study. The Phase I study will be conducted by Quintiles, the world's leading biopharmaceutical services provider.
"This is a major milestone for Kareus, demonstrating the power of its innovation and ability to build a pipeline cost effectively," commented Dr. Uday Saxena, Co-founder & Head of R&D strategy of Kareus.
Dr. Ish Khanna, Head of Preclinical, said, "Our preclinical studies have established that KU-5039 is not only a potent insulin sensitizer in diabetic models but has superior side effects profile including no weight gain, no lactic acidosis and no hypoglycemia in comparison to currently available anti-diabetic drugs. We believe KU-5039 represents an important step towards identification of more effective options to treat diabetes."
Diabetes mellitus is a metabolic disorder affecting large population. As per International Diabetes Federation about 400 million people worldwide have diabetes and approximately 4.6 million patient die from the disease annually. However many of the current therapies have side effects such as weight gain, hypoglycemia and gastrointestinal intolerance. Insulin resistance (IR), which is present in 90% of patients with diabetes, is considered as a major predictor for the onset of type 2 diabetes. In addition, multiple studies have documented an association between IR and accelerated cardiovascular disease (CVD) in patients with type 2 diabetes, as well as in non-diabetic individuals..
About Kareus Therapeutics SA
Kareus Therapeutics SA is a biopharmaceutical company that discovers and develops novel molecules for treatment of unmet needs in age-related and chronic diseases. Founded by Dr. K. Anji Reddy, Kareus has pipeline of clinical and preclinical assets with distinct product profile. Kareus' pipeline also includes, a CNS candidate KU-046, which is undergoing phase I trial, and a preclinical candidate to treat chronic pain.
Kareus' business strategy is to form strategic alliances with leading pharmaceutical companies or partners with complementary skills to maximize the potential of its molecules. In 2011, Kareus entered into a strategic drug development alliance with Quintiles to progress Kareus' pre-clinical programs (Alzheimer's and Type-2 diabetes) into early clinical development.
For further information, please visit http://www.kareustherapeutics.com.
SOURCE: Kareus Therapeutics SA
For further information: Kapil Mishra, Director - Business and Corporate Development, +41-32-967-9024, [email protected]