Innovent Biologics, Inc, a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announced that the U.S. Food and Drug Administration (FDA) has approved the investigational new drug (IND) application to initiate a Phase 1 clinical trial of IBI3032, the company's novel oral GLP-1R agonist.

IBI3032 is an orally administered small-molecule GLP-1 receptor agonist with bias for cAMP signaling pathway, discovered and developed by Innovent Biologics with proprietary rights. Preclinical data demonstrate its superior pharmacokinetic (PK) and physicochemical properties compared to peer compounds. In animal models, IBI3032 achieved 5 to 10 times higher oral exposure at equivalent doses, with improved efficacy and good tolerability in both GLP-1R KI DIO mice and obese monkey models, achieving comparable therapeutic effects at lower doses.

The Phase 1 clinical trials of IBI3032 are planned to be conducted concurrently in China and the U.S. Dosing in healthy volunteers and overweight or obese participants is expected to begin in the second half of 2025. Innovent is building up its CVM pipeline with mazdutide as the cornerstone, and the initiation of the IBI3032 clinical study marks a significant step in the evolution of its CVM pipeline portfolio with global potential.

Dr. Lei Qian, Chief R&D Officer for General Biomedicines Pipeline at Innovent Biologics, said, "GLP-1 has emerged as a blockbuster target over the past decade. Its oral form, with its convenience, flexibility, and unique advantage in combination treatment strategies, holds promise as a differentiated complement to GLP-1R-targeting biologicals. Beyond traditional applications in diabetes and weight management, oral GLP-1 possess potential in treating related diseases such as hypertension and OSA (obstructive sleep apnea). IBI3032 has demonstrated its promising efficacy profiles in animal models, where IBI3032 exhibited a longer elimination half-life and higher drug exposure levels than its competitors at the same dose. We are excited to advance this candidate into clinical development. This IND approval reflects Innovent's strong R&D capabilities and, most importantly, our commitment to global innovation. We hope that in the near future, IBI3032 can offer more effective and convenient treatment options to benefit patients around the world. "

IBI3032 is a novel oral small molecule glucagon-like peptide-1 receptor agonist (GLP-1RA). By efficiently and selectively targeting GLP-1R, it activates downstream signal transduction, thereby delaying gastric emptying, inhibiting appetite, and promoting insulin secretion, and ultimately supporting the treatment of insulin-related metabolic diseases such as obesity and T2DB. Discovered through a structure-based drug design (SBDD) strategy combined with systematic physicochemical property optimization, IBI3032 has shown better PK and physicochemical properties compared to similar compounds.

The IND application of IBI3032 was accepted by China's National Medical Products Administration (NMPA) and approved by the U.S. Food and Drug Administration (FDA). A multi-regional Phase 1 clinical study of IBI3032 is planned for initiation in the second half of 2025.

Source: prnewswire.com