Inversago Pharma’s INV-202 shows promising effects in metabolic syndrome
Inversago Pharma, a Canadian clinical stage company, has announced positive data from its Phase 1b trial for INV-202, a peripherally-acting CB1r blocker, which is being developed to treat metabolic syndrome and associated complications.
INV-202 demonstrated favorable safety and tolerability, as well as pharmacokinetic (PK) and pharmacodynamic (PD) effects in the early-stage trial in subjects with features of metabolic syndrome over a 28-day treatment period.
The results of the trial will be presented in a poster session at the 83rd American Diabetes Association Scientific Sessions (ADA) in San Diego.
The randomized, double-blind Phase 1b study involved 37 adult subjects with features of metabolic syndrome who received 25 mg of INV-202 orally, once daily, for 28 days. The treatment was well-tolerated, with no serious adverse events (SAEs) reported during the trial.
The observed adverse events (AE) were primarily gastrointestinal-related.
In a post-hoc analysis, INV-202-treated subjects showed a clinically significant and progressive weight loss, with an average decline of 3.50 kg (7.7 lb) compared to an average gain of 0.55 kg (1.2 lb) for subjects on placebo (p<0.01).
The treated group also experienced a 3.3% decline in weight compared to a 0.5% gain for the placebo group (p<0.01). Waist circumference was reduced by an average of -1.91 cm (-3/4 in) for treated subjects, while subjects on placebo showed an increase of +0.02 cm (+1/64 in) (p=0.03).
INV-202-treated subjects also reported an average decline in hemoglobin A1C (HgbA1C) of -0.005% compared to an increase of +0.065% for placebo subjects (p=0.08). Positive trends in lipids and glucose measures were also observed, including a decline in triglycerides and LDL-C levels for the INV-202-treated group compared to placebo (p=0.09 and p=0.004, respectively).
INV-202, a small molecule CB1r blocker, is being developed for the potential treatment of various cardiometabolic conditions, including diabetic kidney disease (DKD). It is designed to selectively block CB1 receptors in peripheral tissues such as the kidneys, gastrointestinal tract, liver, pancreas, adipose tissues, muscles, lungs, and other organs.
The therapeutic potential of peripheral CB1r blockade in a range of cardiometabolic and fibrotic diseases is well-documented, offering a promising treatment option for patients with unmet needs. INV-202 is currently undergoing evaluation in a Phase 2 study for patients with diabetic kidney disease.
François Ravenelle — Inversago Pharma CEO said: “We believe this encouraging data for INV-202, along with our preclinical findings, underscore the unique potential effect of our lead first-in-class, peripherally-acting CB1r blocker on metabolic syndrome as well as obesity.
“We are also pleased with its safety profile and the broad metabolic effects that INV-202 had on lipid and glucose measures.”