Inversago Pharma has dosed the first subject in a Phase Ib clinical trial of its lead molecule, INV-202, to treat metabolic syndrome.
INV-202 is a first-in-class, peripheral inhibitor of cannabinoid type 1 receptor.
The trial will analyse the safety profile and pharmacokinetics of INV-202 in 40 subjects with metabolic syndrome.
Topline data from the trial is anticipated in the second half of this year.
Inversago CEO Dr François Ravenelle said: “We are pleased that the clinical trials for INV-202, our first-in-class, peripheral CB1 inhibitor, are moving ahead swiftly.
“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.”
Peripheral CB1 inverse agonists, such as INV-202, could address various pathways linked to renal injury.
CB1 inverse agonists were found to offer clinical benefits in lipids, weight reduction and glucose in addition to effects on albuminuria in pre-clinical models.
Furthermore, these effects each demonstrated to possess reno-protective properties.
The company intends to commence a Phase II trial of diabetic nephropathy (DN) patients on obtaining data from the Phase I trial.
DN is characterised by chronic loss of kidney function in type-1 and type-2 diabetes patients who also often have obesity.
This patient profile enables the objective evaluation of DN-specific primary endpoints and secondary endpoints significant to metabolic diseases in general.
Inversago believes that this indication could offer the necessary proof of concept to show the therapeutic breadth of INV-202 as well as other assets in its pipeline.
In January this year, the company concluded the Phase I trial of INV-202 to treat metabolic disorder complications.
Findings showed that INV-202 had favourable safety, tolerability and pharmacokinetics to progress to further trials.