InVasc Therapeutics, Inc., announced today that it has initiated a Phase IIa, proof of concept (POC), clinical trial with INV-144, a combination drug of losartan with alpha Lipoic Acid (ALA), to slow the progression of chronic kidney disease (CKD) in hypertensive diabetic patients. The trial, which is being conducted under an IND in the United States, is a multi-center, randomized, double-blind, active-controlled study that will compare the treatment of patients with losartan alone versus losartan plus ALA. Each arm of the trial will enroll 40 patients. Losartan is already approved for the treatment of patients with CKD. ALA, a powerful antioxidant, is a widely used nutraceutical in the U.S.; and in Europe, it has been approved for treating diabetic peripheral neuropathy.
"The initiation of this POC study in patients with CKD is an important milestone. The study allows us to compare INV-144 to an early version of the drug, INV-141, that previously demonstrated statistical significance in similar patients," stated William D. Johnston, Ph.D., Chief Executive Officer of InVasc. "We anticipate that this study will provide the data needed to move forward with additional studies designed to optimize this combination drug."
InVasc Therapeutics, Inc.