Inversago Pharma Inc. (“Inversago”), a leader in the development of peripherally-acting CB1 receptor (CB1r) blockers to address complications associated with metabolic and fibrotic diseases, today announced data from its Phase 1b trial for INV-202 to be presented in a poster session at the 83rd American Diabetes Association Scientific Sessions (ADA) in San Diego. INV-202 is a potential first-in-class, peripherally-acting CB1r blocker, being developed to treat metabolic syndrome and associated complications. Phase 1b clinical results demonstrated favorable safety and tolerability as well as pharmacokinetic (PK) and pharmacodynamic (PD) effects in subjects with features of metabolic syndrome over a 28-day treatment period.
The data will be presented in a poster presentation (431-P) entitled “Effects of CB1 Antagonist INV-202 in Patients with Metabolic Syndrome—A Randomized, Placebo-Controlled, Double-Blind Phase 1B Study” on Monday, June 26, at 11:30 AM PT.
The Phase 1b study was a randomized, double-blind clinical trial conducted in 37 adult subjects (46% female; mean age, 55 years) with features of metabolic syndrome to evaluate the PK/PD relationship and other biomarkers of 25 mg of INV-202 administered orally, once daily, over 28 days. Metabolic syndrome was defined by hypertriglyceridemia, abdominal obesity, and impaired glucose tolerance. At 25 mg, INV-202 was well-tolerated with no serious adverse events (SAEs) reported during the treatment period. Observed adverse events (AE) were predominately GI related.
In the post-hoc analysis, over the 28-day treatment period, clinically significant and progressive weight loss of an average decline of 3.50 kg (7.7 lb) for the INV-202-treated subjects was shown. This compared with a gain of 0.55 kg (1.2 lb) on average for subjects on placebo (p<0.01). Weight loss for subjects treated with INV-202 averaged a 3.3% decline versus a 0.5% gain for subjects on placebo (p<0.01). Average waist circumference was reduced by -1.91 cm (-3/4 in) for treated subjects compared to an increase of +0.02 cm (+1/64 in) for subjects on placebo (p=0.03).
INV-202-treated subjects also reported average decline in hemoglobin A1C (HgbA1C) of -0.005% over the treatment period versus an increase of +0.065% for subjects on placebo (p=0.08).
Other positive trends in lipids and glucose measures were also reported. Triglycerides declined -0.179 mmol/L for subjects treated with INV-202 versus an increase of +0.095 mmol/L for placebo (p=0.09). LDL-C decreased -0.50 mmol/L for the treated group compared with a +0.02 mmol/L increase for placebo (p=0.004).
“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,” said François Ravenelle, PhD, Chief Executive Officer of Inversago. “We are also pleased with its safety profile and the broad metabolic effects that INV-202 had on lipid and glucose measures.”
“Peripheral CB1r blockade is implicated in the pathophysiology of a number of metabolic and fibrotic diseases,” added Dr. Glenn Crater, FCCP, Chief Medical Officer at Inversago. “INV-202 has the potential to address the significant unmet medical need in metabolic diseases, such as diabetic kidney disease, as well as in other complications of diabetes and obesity.”
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