FREDERICK, Md., Dec. 10, 2024 /PRNewswire/ — Theradaptive, a privately held, clinical stage biologics company developing protein therapeutics for spine, orthopedics, soft tissue repair, and targeted immuno-oncology, announced today that the US Food and Drug Administration (FDA) has approved an expansion to its Phase I/II clinical program, broadening it to include three spinal fusion indications and tripling the number of investigational sites in the US.
The OASIS trial was approved by the FDA earlier this year to assess the safety and efficacy of OsteoAdapt™ SP, Theradaptive’s implant with targeted biologics to treat degenerative disc disease, in a transforaminal interbody fusion (TLIF) approach. The recent approval encompasses two other common spinal fusion approaches: anterior lumbar interbody fusion (ALIF) and lateral lumbar interbody fusion (LLIF). The company anticipates enrollment of its first ALIF and LLIF study subjects in early 2025.
“Theradaptive is the only advanced therapeutics company to be investing in IDE studies with indications spanning ALIF, TLIF, and LLIF. This is a testament to the value of the three breakthrough designations that were awarded by the FDA and enables us to treat a larger number of patients who are in need of this technology.” Dr. Alvarez stated. “Our TLIF trial is being executed to plan, with multiple sites already activated and enrolling patients, and this most recent approval for ALIF and LLIF accelerates our ability to reach the market and strengthens our confidence in our path to commercialization.”
“ALIF and LLIF are rising in popularity among spine surgeons because they accommodate larger interbody cages, and subsequently larger volume of graft material to encourage fusion,” said Frank Vizesi, PhD, Chief Scientific Officer at Theradaptive. “Collectively, with TLIF, these represent the vast majority of degenerative lumbar fusion procedures both now and in the future. Having FDA’s approval to study OsteoAdapt in these indications gives Theradaptive the opportunity to de-risk our regulatory pathway and ultimately help even more spinal fusion patients.”
About OsteoAdapt SP
OsteoAdapt SP is an investigational biologic 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. In multiple large animal studies, OsteoAdapt has demonstrated more robust and faster bone-formation than the gold standard autograft. OsteoAdapt is limited by Federal (or United States) law to investigational use. 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.
About Theradaptive
Theradaptive is a privately held, clinical stage biologics company developing protein therapeutics for spine, orthopedics, soft tissue repair and targeted immuno-oncology, based in Frederick, Maryland, the Company is leveraging its therapeutic delivery platform to deliver recombinant biologics to targeted areas in the body with high precision and persistence to address unmet medical needs. For more information on Theradaptive and its clinical development program, visit www.theradaptive.com and follow the company on Linkedin. OsteoAdapt™ SP is an Investigational Device. Limited by US Federal law to investigational use.
The work was supported by the Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense, in the amount of $7,408,939, through the Peer Reviewed Medical Research Program under Award No. HT9425-23-1-0693. Opinions, interpretations, conclusions and recommendations are those of the author(s) and are not necessarily endorsed by the Assistant Secretary of Defense for Health Affairs or the Department of Defense.
Contacts:
Theradaptive
Serena Lertora
serena.lertora@theradaptive.com
Investors:
ICR Healthcare
Stephanie Carrington
stephanie.carrington@icrhealthcare.com
(646)277-1282
SOURCE Theradaptive