5 December 2022 - - The first patient has been dosed with INV-202 in a Phase 2 clinical trial in subjects with diabetic kidney disease, Canada-based clinical stage biotech company Inversago Pharma Inc said.

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.

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.

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.

Diabetic Kidney Disease 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.

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.