Inversago Pharma Inc. (“the Company” or “Inversago”), the peripheral CB1 blockade company, today announced it has initiated a Phase 1 clinical trial of INV-101, the Company’s peripherally-acting CB1 blocker, which is being developed for the treatment of Prader-Willi syndrome (PWS) and non-alcoholic steatohepatitis (NASH).
The trial will evaluate the safety, tolerability and pharmacokinetics of INV-101. Recruitment is ongoing and will enroll healthy participants in Canada, from 18 to 55 years old. Subjects will initially be randomized to receive a single dose of placebo or one of 5 dose levels of INV-101.
“With the launch of this first-in-human trial, Inversago is now a clinical-stage company, and confirms its lead in the comeback of small molecule peripheral CB1 blockers”, said François Ravenelle, PhD, CEO and founder of Inversago Pharma.
“Dosing of our first patient with INV-101 represents an important milestone to accomplish the Company’s vision: offering a potentially meaningful therapeutic option to underserved patient populations, like in PWS and NASH" said Carlo Incerti, M.D., Chairman of the Board of Inversago. "This study is the first step in the clinical development of our peripherally-acting CB1 blockers, and we expect it to provide important information about its safety and pharmacokinetics profile", concluded Dr. Incerti.
The Company’s second program, INV-202, is presently in IND-enabling preclinical studies, while other programs are in earlier stages of development. With its current pipeline, Inversago is well positioned to fully exploit peripheral CB1 blockade for a wide range of underserved metabolic indications with differentiated products.
INV-101 is a first-in-class, small molecule CB1 inverse agonist / antagonist being developed by Inversago for the treatment of PWS and NASH. It is specifically designed to interact with peripheral CB1 receptors located in the gastro-intestinal tract, liver, pancreas, adipose tissues, muscles, lungs and other organs, thus aiming at a safe and effective therapeutic approach without the known liabilities of centrally-acting CB1 blockers. The peripheral CB1 blockade is a well-documented pathway, linked to many clinically meaningful metabolic benefits.
About Inversago Pharma
Inversago Pharma is a clinical-stage, biotech company specialized in the development of new therapies focusing on CB1 blockade, based on first-in-class, peripherally-acting CB1 inverse agonists. The Company aims to provide new treatment options that improve the lives of patients affected by metabolic conditions such as Prader-Willi Syndrome (PWS), non-alcoholic steatohepatitis (NASH), type 1 diabetes (T1D) and diabetic nephropathy. For more information, visit inversago.com.
Picture of our CEO and company logotype available for download at: inversago.com/en/media/