• OsteoAdapt SP demonstrated more robust and faster bone formation than the gold standard autograft in a large animal model of spinal fusion
• The study demonstrated the safety and efficacy of AMP2 and the utility of OsteoAdapt SP at multiple dosages, in support of human IDE Phase I/II clinical studies, which are currently underway

FREDERICK, Md., Nov. 6, 2024 /PRNewswire/ -- Theradaptive, a privately held, clinical stage biologics company developing targeted protein therapeutics for spine, orthopedics, soft tissue repair and targeted immuno-oncology, today announced the peer-reviewed publication of a preclinical spinal fusion study. This study features Theradaptive's lead candidate, OsteoAdapt SP, in Spine, the preeminent journal for spinal surgeons (Volume 49, Issue 19). The study, entitled "In vivo Assessment of AMP2, a Novel Ceramic-Binding BMP-2, in Ovine Lumbar Interbody Fusion," demonstrated the preclinical safety and efficacy of OsteoAdapt SP in a clinically relevant large animal model. Results showed faster and more robust new bone formation within the interbody cage, performing as well as or better than the gold standard, autologous iliac crest bone graft (ICBG), in all evaluated measures.

"The findings from this study highlight the transformational potential of OsteoAdapt SP to revolutionize spinal fusion procedures by significantly enhancing bone formation and improving outcomes, potentially giving surgeons the option to completely eliminate the need for autograft," stated Luis Alvarez, PhD, CEO and Founder of Theradaptive. "We have already advanced into human clinical trials and expect that these preclinical results will translate into similarly outstanding outcomes in a patient population that is growing and has significant unmet needs".

OsteoAdapt SP: A Novel Approach to Treating Degenerative Disc Disease
OsteoAdapt SP is an investigational therapeutic designed for patients with degenerative disc disease, a condition characterized by the deterioration of spinal joints that results in pain and dysfunction. It combines Theradaptive's next-generation engineered protein AMP2, a modified, adhesive variant of the powerful bone-forming growth factor bone morphogenetic protein-2 (BMP-2), with a synthetic bone graft. This modification allows OsteoAdapt SP to retain BMP-2's therapeutic benefits while minimizing off-target effects often associated with BMP-2. Theradaptive is currently enrolling patients in OASIS, its Phase I/II clinical trial evaluating the safety and efficacy of OsteoAdapt SP for the treatment of degenerative diseases of the lumbosacral spine.

Study Design and Results
The preclinical study was designed to compare OsteoAdapt SP with ICBG in a lumbar interbody fusion model. Sheep underwent lateral lumbar fusion surgery with either PEEK or Titanium interbody cages packed with low or high doses of OsteoAdapt SP or ICBG. Outcomes were evaluated at 8-, 16- and 26- week intervals. Newly formed bone quality, bone mineralization, and fusion were assessed by manual palpation, qualitative and semi-quantitative histopathology, histomorphometry, computed tomography (CT), and micro-CT (μCT) analysis.

Key findings include:

1. The use of AMP2, Theradaptive's proprietary adhesive variant of BMP-2, showed healing outcomes equivalent to or better than ICBG
2. The precise delivery of the protein assisted healing and reduced the risk of off-target effects

The full results are available in the journal Spine (Volume 49, Issue 19) and online here

About Theradaptive
Theradaptive is a privately held, clinical stage biologics company developing targeted protein therapeutics for spine, orthopedics, soft tissue repair and immuno-oncology. Based in Frederick, Maryland, the Company is leveraging its therapeutic delivery platform to deliver recombinant biologics to targeted tissues in the body with high precision and persistence to address unmet medical needs. For more information on Theradaptive and its clinical development program, visit and follow the company on LinkedIn. OsteoAdapt SP is an Investigational Device. Limited by US Federal law to investigational use.

Contacts:
Theradaptive
Serena Lertora
[email protected]

Investors:
ICR Healthcare
Stephanie Carrington
[email protected]
(646)277-1282

SOURCE Theradaptive