Zetagen Receives Approval in Australia to Begin Pilot Study of ZetaFuse® Bone Graft to Treat Cervical Degenerative Disc Disease

• Randomized, open-label, two-level cervical study will examine safety and efficacy of using ZetaFuse^® in patients being treated with anterior cervical discectomy and fusion (ACDF) surgery.   
• ZetaFuse^® is a synthetic, small molecule, osteo-inductive biologic, designed to aid bone healing of spinal fusions. 
• ZetaFuse^® was granted FDA Breakthrough Device Designation for treatment of the complete spinal column, inclusive of the cervical, thoracic, and lumbar regions.

November 6, 2023, (Syracuse, New York) - Zetagen Therapeutics, a private, clinical-stage, biopharmaceutical company focused on driving breakthrough innovation in the treatment of metastatic cancers to bone and soft tissue organs as well as osteologic interventions, today announced its approval from the Human Research Ethics Committee (HREC) of Australia to begin a pilot study using its novel therapy ZetaFuse^® bone graft for the treatment of cervical degenerative disc disease. The pilot study is a randomized, open-label, two-level cervical program which will examine the safety and efficacy of ZetaFuse^® bone graft in patients undergoing anterior cervical discectomy and fusion (ADCF) surgery.

“We are pleased to begin this pilot study in Australia,” said Joe C. Loy, CEO of Zetagen Therapeutics. “If successful, ZetaFuse^® will be another asset to our growing pipeline of therapies focused on serious osteologic issues ranging from lytic lesions in metastatic cancers to various skeletal related events.”

“For patients living with cervical degenerative disc disease, ACDF surgery is an option to relieve pain and stabilize the spine,” said Nikhil Thakur, MD, co-founder, and Chief Medical Officer of Zetagen Therapeutics. “Our hope is that by introducing ZetaFuse^® bone graft as part of the ACDF surgical procedure we can empower spine surgeons with a safe, osteoinductive treatment option.”

ZetaFuse^®, is a synthetic, small-molecule, osteo-inductive biologic technology being developed to aid in bone healing of spinal fusions. It works through a mechanism of action (MOA) which is a novel and patented molecular pathway. When the pathway is activated, it stimulates stem cells, activating cells to grow healthy bone known as “osteoblasts”, and inhibits cells associated with bone degradation called “osteoclasts”, preventing bone resorption.

ZetaFuse^® was granted Breakthrough Device Designation status in 2021 from the U.S. Food and Drug Administration (FDA) for spinal fusion procedures including interbody fusion in the anterior cervical, thoracic, and lumbar spine or posterior fusions in the cervical, thoracic, and lumbar spine.

In the United States, interbody spinal fusion surgeries are the most commonly performed spinal procedures, stemming often from diagnoses of lumbar degenerative disc disease and cervical disc replacement. In the last 20 years, spinal fusion procedures have increased nearly two-fold, with an estimated 450,000 lumbar and 150,000 cervical spinal fusion procedures performed annually.[1]

The two year study will enroll 10 patients and be conducted at Prince of Wales Hospital and Prince of Wales Private Hospital in Australia.

[1] J Spine Surg 2020;6(4):752-761 | http://dx.doi.org/10.21037/jss-20-492