Angitia Biopharmaceuticals’ Post

Angitia Announces that NMPA has Granted Phase III IND Approval for AGA111, a Drug Candidate for Spinal Fusion Guangzhou, China, and Woodland Hills, California, USA –16 Oct 2023: Angitia Biopharmaceuticals, a global clinical-stage biotechnology company focused on the discovery and development of breakthrough therapies that address the unmet medical needs of patients with serious musculoskeletal disease, announced today that National Medicinal Product Administration (NMPA) has approved Angitia Biopharmaceuticals’ Investigational New Drug (IND) application of the Phase III study for AGA111. Angitia has previously announced the encouraging results from AGA111’s Phase I/II trial, which demonstrated excellent safety and preliminary efficacy in lumbar interbody fusion. The Phase III, randomized, double-blind, placebo-controlled trial aims to evaluate the efficacy and safety of a single intervertebral local administration of AGA111 in patients with degenerative disc disease undergoing lumbar interbody fusion. “We are delighted to share this exciting news, which is an important milestone for Angitia, as our first program to initiate a pivotal trial. Based on the encouraging Phase I/II study results, we believe that AGA111 has the potential to significantly accelerate bony fusion, reduce nonunion rate, and meaningfully improve patient outcomes.” said David Ke, M.D., Founder and CEO of Angitia. About Spinal Fusion Spinal fusion is a widely used surgical treatment for spinal disorders. The incidence of nonunion after spinal fusion surgery has been reported as high as 56% in the lumbar spine [1]. A large case report shows that up to 23.6% of spinal revision surgery is related to nonunion [2]. Nonunion of the spine can have significant adverse impact on postoperative function and clinical outcomes [3]. Reference     1.   Lee C, Dorcil J, Radomisli TE. Nonunion of the spine: a review. Clin Orthop Relat Res. 2004;(419):71-75. doi:10.1097/00003086-200402000-00012 2.   Raizman NM, O'Brien JR, Poehling-Monaghan KL, Yu WD. Pseudarthrosis of the spine. J Am Acad Orthop Surg. 2009;17(8):494-503. doi:10.5435/00124635-200908000-00003 3.   Tsutsumimoto T, Shimogata M, Yoshimura Y, Misawa H. Union versus nonunion after posterolateral lumbar fusion: a comparison of long-term surgical outcomes in patients with degenerative lumbar spondylolisthesis. Eur Spine J. 2008;17(8):1107-1112. doi:10.1007/s00586-008-0695-9