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Angitia Biopharmaceuticals Announces Positive Topline Results from AGA111 Phase 1/2 Trial for Spinal Fusion

Guangzhou, Guangdong, China, and Woodland Hills, California, USA: Angitia Biopharmaceuticals (Angitia) today announced the successful conclusion and positive top-line results of a phase 1/2 study entitled ‘A randomized, double-blind, placebo-controlled study to evaluate the safety and preliminary efficacy of a single intervertebral administration of AGA111 in patients with degenerative disc disease undergoing interbody fusion’. The results from this trial demonstrated an excellent safety profile and preliminary efficacy in increasing fusion rate and improving clinical outcome. 

Spinal fusion is a widely used surgical treatment for spinal disorders. In spine surgery, lumbar interbody fusion with help of pedicle screws from the back of the spine is one of the most common surgical procedures to treat these conditions. 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]. AGA111 is a new drug candidate tested for accelerating bony fusion and improving clinical outcome for spinal fusion surgery.

This trial was a multicenter, randomized, double-blind, placebo-controlled phase 1/2 study to evaluate the safety and preliminary efficacy of a single, local administration of AGA111 to the intervertebral body in patients with degenerative disc disease undergoing interbody fusion. Subjects enrolled in this trial were recruited from 6 renowned hospitals. Patients were randomized to receive AGA111 (low dose), AGA111 (high dose), or placebo in a 1:1:1 ratio. The primary objective of the study was to assess the safety and tolerability of AGA111. The secondary objective was to assess the preliminary efficacy including fusion rate and clinical outcomes. The results showed that AGA111 was well tolerated at both dose levels. The incidence of adverse events (AEs) in patients receiving AGA111 was comparable with those in the placebo group. Efficacy results demonstrated that a single administration of AGA111 to intervertebral body during spinal fusion surgery resulted in increased fusion rate and improved clinical outcomes as compared with placebo control.


“I am very encouraged by the safety and efficacy profile of AGA111 from this clinical trial. There is currently no approved drug therapy for improving fusion rate and clinical outcome for patients undergoing spinal fusion surgery. We look forward to the further clinical development of AGA111 to address this unmet medical need." said Professor Weishi Li, the leading principal investigator of the study, Chair of the Orthopedics Department at Peking University Third Hospital and Chairperson of AO Spine China Council.


Dr. David Ke, Founder and CEO of Angitia, added, “The positive topline results of AGA111 Phase 1/2 study demonstrated what we believe to be clinically meaningful acceleration of spinal fusion with improved clinical outcome. These positive data provided strong evidence in supporting the continuing clinical development of AGA111. We believe AGA111 has the potential to be the first drug therapy in helping patients who undergo spinal fusion surgery by accelerating fusion, improving clinical outcome, and reducing the risk of revision surgery.”


About Angitia Biopharmaceuticals

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


Founded in 2018, Angitia is now with operation sites in Guangzhou, Guangdong, China and in Woodland Hills, California, USA.


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