Kareus Therapeutics announced Wednesday that the US FDA has approved its Phase I clinical trial, which will be run by CRO Quintiles.
The drug, known as KU-9k5039, is being developed for the treatment of insulin resistance and diabetes. The drug is a potent and selective activator of AMP-kinase, 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 animal models for the treatment of insulin resistance and diabetes.
Quintiles will begin first-in-human trials to evaluate safety, tolerability and pharmacokinetics in a randomized, double-blind, placebo-controlled study. Quintiles did not respond to a request for comment.
The move follows Quintiles’ decision to shutter its Phase I unit in India , acquire Novella , and re-iterate its focus on large-scale deals. As of last summer, investment analysts seemed to offer a generally positive outlook on Quintiles stock.
Dr. Ish Khanna, head of preclinical at Kareus, 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."
"This is a major milestone for Kareus, demonstrating the power of its innovation and ability to build a pipeline cost effectively," said Dr. Uday Saxena, co-founder & head of R&D strategy of Kareus.