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Angitia Biopharmaceuticals Announces the First Subject Dosed in a Phase III Registrational Trial of AGA111, a Drug Candidate for Enhancing Spinal 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. Over 30 elite spine surgery centers are participating in this study, and the first subject was dosed successfully on 8th December 2023.  

“In an aging society, nonunion after spinal fusion surgery has become a disturbing risk for patients undergo spinal fusion surgery. Based on the encouraging Phase I/II trial results, we believe that AGA111 has the potential to significantly accelerate bony fusion, reduce nonunion rate, and meaningfully improve patient outcomes. We are delighted to share this exciting news which is an important milestone for the AGA111 program. Angitia will continuously focus on clinical development of AGA111 with the aim of bringing this innovative therapy to help patients in need.” said Willard Dere, M.D., Chief Medical Officer 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 has significant adverse impact on postoperative function and clinical outcomes [3]. 

About Angitia Biopharmaceuticals 

Founded in 2018, Angitia is a clinical-stage biotechnology company focused on the discovery and development of breakthrough therapeutics that address the key unmet medical needs in serious musculoskeletal disease. With the team’s experience and scientific expertise in novel drug development, Angitia is dedicated to bringing innovative therapies to help patients in need.  

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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 

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