-Study results demonstrated favorable safety, tolerability, and PK profile
-Clinically significant weight loss was observed in only 28 days
-Positive trends in lipids and glucose effects were also shown
Montreal, Canada and San Diego, CA – June 23, 2023 – 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.”
INV-202 is a small molecule CB1r blocker being developed for the potential treatment of a range of cardiometabolic conditions, including diabetic kidney disease (DKD). 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 CB1r 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. INV-202 is being evaluated in a Phase 2 study for patients with DKD.
About Peripherally-acting CB1r Blockers
Peripherally-acting CB1r blockers, such as Inversago’s INV-202, have the potential to provide significant clinical benefits without the side effects noted with the previous class, linked to brain target engagement. The therapeutic relevance of the peripheral CB1r pathway is well understood and is implicated in the pathophysiology of a majority of metabolic and fibrotic diseases which pertains to the lungs, pancreas, liver, kidneys and GI tract. The mechanism of action of Inversago’s molecules seeks to address the safety limits associated with first generation, centrally-acting CB1r blockers in order to bring safe and potent therapies to the growing number of patients who need them.
Based in Montreal Canada, Inversago Pharma, is a privately owned, clinical stage company, and leader in the development of peripherally-acting CB1r blocker therapies designed to help patients with complications associated with metabolic and fibrotic diseases. Inversago aims to provide new treatment options that improve the lives of patients affected by diabetic kidney disease (DKD), including diabetic nephropathy (DN), type 1 and type 2 diabetes (T1D / T2D), non-alcoholic steatohepatitis (NASH), complications of obesity and hypertriglyceridemia (HTG), as well as fibrotic indications like progressive fibrosis-interstitial lung disease (PF-ILD), including idiopathic pulmonary fibrosis (IPF) and other conditions.
Glenn S. Vraniak
Chief Financial Officer
Inversago Pharma Inc.
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