Inversago Pharma Doses First Patient in Phase 2 Trial of INV-202, an Oral, Peripherally-acting CB1 Inverse Agonist, in Patients with Diabetic Kidney Disease

Inversago Pharma Inc. (“Inversago”), a clinical stage biotech company with a unique portfolio of peripherally-acting CB1 inverse agonists, today announced that the first patient has been dosed with INV-202 in a Phase 2 clinical trial in subjects with diabetic kidney disease (DKD).

The Phase 2 trial of INV-202, a first-in-class, peripherally-acting CB1 inverse agonist, is a multi-centered, randomized, double-blind, placebo-controlled study that will evaluate the albumin to creatinine ratio in up to 240 adult subjects with type 1 and type 2 diabetes and DKD. Participants will receive once-daily oral doses of 10 or 25mg of INV-202 or placebo during the 16-week study. Additional trial information can be found at https://clinicaltrials.gov/ via the identifier NCT05514548.

This study builds on positive Phase 1b data that will be presented at a future scientific conference. It is also supported by evidence from pre-clinical data, first presented at the European Renal Association meeting in June, that showed strong reno-protective effects of INV-202 in a model of DKD. In addition, data suggest that INV-202 would have additive effects when added to standard of care.

“The initiation of this Phase 2 trial in DKD is a significant milestone in our development plan for INV-202,” said Glenn Crater, MD, Chief Medical Officer at Inversago. “Peripheral CB1 blockade has the potential to address the significant unmet medical need in DKD as well as other complications of diabetes and obesity.”

“We’re excited about the progress of our INV-202 program that represents a novel, orally administered option for treating metabolic conditions,” said François Ravenelle, PhD, Chief Executive Officer at Inversago.

About INV-202

INV-202 is a small molecule CB1 inverse agonist 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

DKD is a chronic progressive disease that accounts for more than 50% of end-stage renal disease cases world-wide. It 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

Inversago Pharma is a privately owned, clinical stage, Canadian biotech company, 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.

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Contact information

Glenn S. Vraniak
Chief Financial Officer
Inversago Pharma Inc.
info@inversago.com

Media and Investors
Argot Partners
inversago@argotpartners.com