Inversago Pharma receives IND clearance for Phase 2 trial of INV-202 in Diabetic Kidney Disease

September 15, 2022 |

3 min read

Inversago Pharma Inc. (“Inversago”), a clinical stage biotech company with a unique portfolio of peripherally-acting CB1 inverse agonists, has received FDA clearance of its Investigational New Drug (IND) application for a phase 2 study in Diabetic Kidney Disease (DKD) for INV-202, the Company’s lead program.

Sept. 15, 2022 12:00 UTC

- FDA clears IND of First-In-Class, Peripherally-Acting CB1 Inverse Agonist INV-202

- Phase 2 trial in Diabetic Kidney Disease will also provide data in complications of diabetes, metabolic syndrome and dyslipidemia

MONTREAL--(BUSINESS WIRE)-- Inversago Pharma Inc. (“Inversago”), a clinical stage biotech company with a unique portfolio of peripherally-acting CB1 inverse agonists, has received FDA clearance of its Investigational New Drug (IND) application for a phase 2 study in Diabetic Kidney Disease (DKD) for INV-202, the Company’s lead program.

Inversago scientists identified Diabetic Kidney Disease as the most promising indication for a Phase 2 study, given its important unmet medical need. Such a study presents an opportunity to evaluate a comprehensive set of biomarker data in DKD that may also be relevant to a broad landscape of diabetic-related indications, including cardiometabolic and fibrotic complications.

INV-202, which is presently completing Phase 1b studies in patients with metabolic syndrome, showed a favorable profile in a first-in-human study, including safety and tolerability, oral absorption, and pharmacokinetics. It also demonstrated potential for decreased appetite, a relevant pharmacodynamic marker of early efficacy of Inversago’s lead program.

Dr. Glenn Crater, CMO at Inversago, stated: “This IND clearance is an important milestone for Inversago and marks the beginning of an important regulatory and clinical process in bringing a new therapeutic approach to patients suffering from Diabetic Kidney Disease.”

“We are excited to report this significant achievement for our first-in-class, peripherally-acting CB1 inverse agonist, which confirms our leadership in this field. We believe that CB1 blockers, such as INV-202, offer opportunities in multiple therapeutic areas,” added François Ravenelle, PhD, Chief Executive Officer of Inversago.

Inversago believes that peripheral CB1 blockade, either alone or in combination with other therapies, represents an opportunity to address the significant unmet medical need of DKD. As obesity, diabetes and their complications continue to affect more people around the world, the need for new therapies will only continue to grow.

About INV-202

INV-202 is a small molecule CB1 inverse agonist / antagonist being developed by Inversago for the potential treatment of a range of cardiometabolic and fibrotic conditions, including Diabetic Kidney Disease. It is specifically designed to preferentially block CB1 receptors in peripheral tissues such as the kidneys, gastro-intestinal tract, liver, pancreas, adipose tissues, muscles, lungs and other organs. The therapeutic effects of a peripheral CB1 blockade in a range of cardiometabolic and fibrotic diseases are well-documented, paving the way for potential treatment of a large number of patients with current unmet needs.

About Diabetic Kidney Disease

Diabetic Kidney Disease (DKD) occurs when diabetes causes damage to the glomeruli and proximal renal tubules that are essential to blood filtering and waste elimination. As a complication of type 1 and type 2 diabetes, diabetic nephropathy affects approximately 1 in 3 people living with diabetes in the United States. No cure exists for this indication and available medications only help slowing the progression of the disease. Like other chronic diseases, it is expected that multiple mechanisms are needed to achieve adequate control of this progressive disease. Inversago believes that peripheral CB1 blockade represents a promising therapeutic avenue for such a metabolic disorder.

About Inversago Pharma

Located in Montreal, Inversago Pharma is a privately owned Canadian biotech company at clinical stage, specialized in the development of new therapies focusing on CB1 blockade, based on first-in-class, peripherally-acting CB1 inverse agonists. Inversago aims to provide new treatment options that improve the lives of patients affected by metabolic conditions such as Diabetic Kidney Disease (DKD), including Diabetic Nephropathy (DN), Type 1 and Type 2 Diabetes (T1D / T2D), Non-Alcoholic Steatohepatitis (NASH), complications of obesity and hypertriglyceridemia (HTG), as well as fibrotic indications like Progressive Fibrosis-Interstitial Lung Disease (PF-ILD), including Idiopathic Pulmonary Fibrosis (IPF) and other conditions. For more information, visit inversago.com.