March 18, 2025 -- Angitia Biopharmaceuticals, a global, clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for serious musculoskeletal diseases, today announced the presentation of data from its randomized, double-blind, placebo-controlled Phase 1/2 study evaluating AGA111 for use in spinal fusion procedures on March 12, 2025, at the 2025 American Academy of Orthopedic Surgeons (AAOS) Annual Meeting in San Diego, California.
In the study, treatment with AGA111, a recombinant human bone morphogenetic protein 6 (rhBMP6), led to faster radiographic fusion and a higher fusion success rate, as well as greater improvements in functional outcomes as assessed by the Oswestry Disability Index (ODI) and pain visual analog scale (VAS), compared to placebo.
“We are honored and excited to present the full dataset from our Phase 1/2 study of AGA111, representing a rare and valuable randomized, placebo-controlled study in the field of orthopedics and spinal fusion,” said Willard Dere, M.D., Chief Medical Officer of Angitia. “Based on these encouraging results, we are now executing a registrational Phase 3 study of AGA111, which we believe has the potential to significantly accelerate bony fusion and meaningfully improve patient outcomes following spinal fusion surgery.”
The Phase 1/2 trial was a randomized, double-blind, placebo-controlled study enrolling 63 patients with degenerative disc disease (DDD) requiring single-level Transforaminal Lumbar Interbody Fusion (TLIF) surgery. Patients were randomized 1:1:1 to 1 of 3 groups: placebo, 0.25mg AGA111, or 0.5mg AGA111. AGA111 or placebo was mixed with autologous blood to create a coagulum, which was then administered into the interbody area during TLIF surgery. No bovine material was used in the treatment or placebo arms. Blinded adjudicators assessed fusion success using CT scan images and hyperflexion/hyperextension X-rays at Months 3, 6, and 12. At the same time, functional outcomes were assessed via the ODI and pain VAS. Study results indicated that AGA111 induced more rapid fusion, increased fusion success rate, and improved functional outcomes compared to placebo.
The abstract outlining the study is entitled, “AGA111, a Recombinant Human Bone Morphogenetic Protein 6 (rhBMP6), Improved Lumbar Interbody Fusion Success Following Single-Level Transforaminal Lumbar Interbody Fusion (TLIF) Surgery in a Phase I/II, Double-Blind, Placebo-Controlled, Randomized Study."
AGA111 is a recombinant human bone morphogenic protein 6 (rhBMP6) product candidate in clinical development to promote bone fusion and functional outcomes in patients undergoing spinal fusion procedures. AGA111 is mixed with autologous blood to create an autologous blood coagulum and administered during the surgery. Angitia is currently studying AGA111 in double-blind, placebo-controlled, randomized Phase 3 study.
Spinal fusion is a widely used surgical treatment for spinal disorders, including degenerative disc disease (DDD). Each year, approximately 146,000 patients in China and over 300,000 patients in the US undergo spinal fusion procedures to treat DDD. The rate of spinal fusion following surgery has a significant impact on patient outcomes. Although lumbar spinal fusion is a commonly performed spinal procedure, it can result in significant morbidity, including nonunion or pseudarthrosis. Patients with nonunion following spinal fusion surgery are at risk for pain, decreased functional outcomes, and re-operation.
Angitia Biopharmaceuticals is a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for serious musculoskeletal diseases. Angitia is currently studying 3 biologic product candidates in clinical studies for the treatment of osteoporosis, osteogenesis imperfecta (OI), and spinal fusion. Leveraging the team's extensive experience and scientific acumen in novel drug development, Angitia is committed to providing groundbreaking therapies to satisfy key unmet medical needs.
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