MONTREAL– Inversago Pharma Inc. (“Inversago”), a clinical stage biotech company with a unique portfolio of CB1 inverse agonists, announced today the dosing of the first participant with metabolic syndrome in a Phase 1b clinical trial.
This 28-day trial will test the pharmacokinetics and safety profile of Inversago’s lead molecule, INV-202, on a targeted population with metabolic syndrome. Topline results from 40 subjects are expected in the second half of the calendar year.
“We are pleased that the clinical trials for INV-202, our first-in-class, peripheral CB1 inhibitor, are moving ahead swiftly,” said Dr. François Ravenelle, Chief Executive Officer of Inversago. “This pharmacokinetic and safety study will also measure a number of well accepted biomarkers of metabolic disorders. Together, these results are expected to act as a guide for the next phase of INV-202’s development.”
Inversago is planning to launch its first Phase 2 study in patients with Diabetic Nephropathy (DN) shortly after results are available. DN involves a chronic loss of kidney function in people with type-1 and type-2 diabetes who also often present obesity. This patient profile allows for the objective measurement of primary endpoints specific to DN and secondary endpoints relevant to metabolic diseases at large. The company believes that this choice of indication provides the optimal proof of concept to demonstrate the therapeutic breadth of opportunity available to INV-202 and the rest of the Inversago pipeline.
Peripheral CB1 inverse agonists, such as Inversago’s lead INV-202 molecule, have demonstrated efficacy in addressing multiple pathways involved in renal injury. Aside effects on albuminuria in pre-clinical models, CB1 inverse agonists have shown clinical improvements in lipids, weight loss and glucose. Each of these effects have separately demonstrated reno-protective characteristics.