Anti-CB1 cannabinoid receptor antibody(Materia Medica Holding Research And Production Company)

The European Medicines Agency will monitor the suicide risk of Novo Nordisk's GLP-1 drugs, including Ozempic. The EMA said it may expand the review to other drugs from the class. Two cases of suicidal thoughts and one case of self-harm from users in Iceland of Novo Nordisk’s diabetes and obesity drugs have prompted the European Medicines Agency (EMA) to review the blockbuster products. The regulator’s Pharmacovigilance Risk Assessment Committee (PRAC) will examine (PDF) Novo’s treatments Ozempic (semaglutide) and Saxenda (liraglutide) to determine if there was a causal relationship between their use and the adverse events. The PRAC also will include another of Novo’s semaglutide drugs, Wegovy, in the study, it said. The GLP-1 treatments have gained a sudden surge in popularity for their ability to trigger weight loss. The EMA added that it will decide whether to expand its review to all drugs in the popular GLP-1 class. That would include Eli Lilly’s fast-rising Mounjaro (tirzepatide). As is the case with many other approved weight management medications, suicidal behavior is listed as a major disease interaction with semaglutide and its use should be “avoided in patients with a history of suicidal attempts or active suicide ideation,” according to its label. In an emailed statement, Novo said that it remains “confident” in the benefit-risk profile of its products and points to the long-standing use of drugs in the class. “GLP-1 receptor agonists have been used to treat type 2 diabetes for more than 15 years and for treatment of obesity for eight years,” the company said. “The safety data collected from large clinical trial programs and post marketing surveillance have not demonstrated a causal association between semaglutide or liraglutide and suicidal and self-harming thoughts.” Another potential disease interaction with GLP-1 treatments is thyroid cancer. In May, the EMA told Novo and other companies with products in the class—including Lilly, AstraZeneca and Sanofi—that it was monitoring the potential for thyroid cancer signals. In the recent report from Iceland, there were suicidal thoughts from one user each of Ozempic and Saxenda. Additionally, the self-harm signal was raised by a user of Saxenda. In 2008, Sanofi’s Acomplia was pulled from the market in Europe—two years after its approval—when some patients suffered depression and suicidal thoughts. The drug, which was a cannabinoid receptor CB1 antagonist, blocked hunger signals to the brain. It was never approved in the U.S. GLP-1 treatments have a different mechanism of action.    

MONTREAL--( BUSINESS WIRE )--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 positive results from a proof-of-concept study of INV-202 in a mouse model of obese asthma at the American Thoracic Society (ATS) International Conference taking place from May 19-24, 2023, in Washington, D.C. In an oral presentation, Carolyn R. Morris, PhD, Faculty Scientist, University of Vermont, Burlington, VT will discuss results from a proof-of-concept study designed to test the efficacy of INV-202 in a mouse model of obese asthma for direct effects on the airway and weight loss. INV-202, Inversago’s lead drug candidate, is a potential first-in-class, peripheral CB1r blocker, being developed to treat metabolic disorder complications. “People with asthma and obesity have worse quality of life, worse asthma control and more exacerbations than people with asthma without obesity, and this is associated with adipose tissue inflammation and metabolic dysfunction,” said Anne Dixon, M.D., Professor of Pulmonology at Larner College of Medicine, at the University of Vermont, in whose lab the study was conducted. “INV-202 is being developed for the treatment of metabolic disorder complications, and this preclinical data demonstrates its potential to also address the large unmet need in asthma complicated by obesity,” added Glenn Crater MD, Chief Medical Officer of Inversago. Presentation Details: Abstract Title: Cannabinoid Receptor 1 Inverse Agonist, INV-202, Induces Weight Loss and Reduces Airway Hyperreactivity in a Mouse Model of Obese Asthma Presenter: Carolyn R. Morris, PhD, Faculty Scientist, University of Vermont, Burlington, VT Session: B15 - ASTHMA: HOT OFF THE PRESS FROM THE BENCH TO THE CLINIC Date and Time: Monday, May 22, 2023, 9:00 - 11:00 AM ET About INV-202 INV-202 is a small molecule CB1r blocker being developed for the potential treatment of a range of cardiometabolic conditions, including diabetic kidney disease. 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 diabetic kidney disease with results expected in mid 2024. About Inversago 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. For more information, visit www.inversago.com .