Angitia Biopharmaceuticals announced positive Phase 1/2 trial data for AGA111, a recombinant human bone morphogenetic protein 6 (rhBMP6) designed for spinal fusion procedures. The treatment demonstrated superior results compared to placebo in achieving fusion and improving patient function. These findings were presented at the 2025 American Academy of Orthopedic Surgeons (AAOS) Annual Meeting.
Successful spinal fusion is crucial for long-term patient outcomes after surgery for conditions like degenerative disc disease (DDD). Faster and more reliable fusion, as indicated by these study results, could significantly reduce patient recovery time, improve quality of life, and lessen the need for revision surgeries. This advancement is particularly important considering the high number of spinal fusion procedures performed annually, representing a large patient population that could benefit.
The Phase 1/2 trial involved 63 patients undergoing single-level Transforaminal Lumbar Interbody Fusion (TLIF). Patients were divided into three groups: placebo, 0.25mg AGA111, and 0.5mg AGA111. The treatment was administered by mixing AGA111 with the patient’s own blood and applying it to the interbody area during surgery. Results showed AGA111 led to more rapid fusion, a higher overall fusion success rate, and better functional outcomes based on the Oswestry Disability Index (ODI) and pain Visual Analog Scale (VAS). Following these promising results, Angitia is now conducting a Phase 3 registrational study.
The positive Phase 1/2 data for AGA111 positions Angitia to potentially offer a significantly improved treatment option for spinal fusion patients. Confirmation of these results in the ongoing Phase 3 trial could lead to a new standard of care in spinal fusion, offering patients faster recovery, reduced pain, and improved long-term outcomes. This development could also positively impact healthcare costs by potentially reducing the need for revision surgeries and extended rehabilitation.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
