Kareus Therapeutics To Initiate Phase I Trial With KU-5039 For Diabetes
By Cyndi Root
Kareus Therapeutics SA will initiate a Phase I trial after its diabetes drug was approved as an Investigational New Drug (IND) by the Food and Drug Administration (FDA). The drug, KU-5039, was developed by Kareus and is a New Chemical Entity (NCE). "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,” said Dr. Ish Khanna, Head of Preclinical at Kareus. Quintiles, a biopharmaceutical services provider, will conduct the study.
Diabetes mellitus is a chronic condition that must be managed over the lifetime. This metabolic condition is widespread in the U.S. and globally, with incidence rising. The disorder occurs when the body fails to produce enough of the hormone insulin or it misuses the insulin. When not enough insulin is available, the body cannot use the glucose formed from food intake. The glucose accumulates and damages the heart, nervous system, kidneys, and eyes. Untreated diabetes leads to blindness, stroke, heart disease, and other serious and life-threatening outcomes.
Current diabetes therapies have side effects and are associated with insulin resistance (IR). When IR is present, patients have higher risks for cardiovascular disease. KU-5039 shows promise in treating IR. KU-5039 is an oral agent and an AMP-kinase (AMPK) activator. AMPK regulates homeostasis in metabolic pathways. Animal models have shown that activating AMPK causes insulin sensitivity and glucose uptake, along with other positive metabolic events. The Phase I clinical study will evaluate tolerability and safety, and better define the drug’s profile. The study will be placebo controlled, double blind, and randomized.
About Kareus Therapeutics SA
Kareus Therapeutics SA develops molecules for chronic diseases. In conjunction with partners, it seeks to develop drugs from initial discovery to clinical trials. Along with KU-5039, Kareus has KU-046, a CNS candidate, in Phase I trial. The pipeline includes Alzheimer’s and type 2 diabetes drugs.