Theradaptive to Expand Global Clinical Trials After Receiving Full Ethics Approval in Australia for OsteoAdapt SP

Theradaptive can now enroll patients at each site in Australia listed with Bellberry as part of its global clinical study for OsteoAdapt SP.

FREDERICK, Md., Feb. 27, 2024 /PRNewswire-PRWeb/ — Theradaptive, a market leader in targeted regenerative therapeutics, has received full ethics approval from the Bellberry Ethics Committee to commence its OASIS in-human study in Australia for its novel spinal fusion implant OsteoAdapt SP. Theradaptive can now enroll patients at each site in Australia listed with Bellberry as part of its global clinical study for OsteoAdapt SP, thus extending Theradaptive’s OASIS trial already enrolling patients in the US.

With the over 65 population in Australia expected to almost double to 6.7 million by 20421, the demand for spinal fusion surgery will continue to increase. Degeneration of the discs that support the vertebrae in the lower part of the spine is an inevitable part of the aging process. Current surgical options are not effective for all patients, leading to ongoing pain, the need for further, complex surgery, and reliance on prescription pain medication. Techniques currently used are also associated with severe pain, loss of mobility and a significant impact on quality of life.

Advancing spinal fusion outcomes for patients
Theradaptive aims to advance the standard of care with OsteoAdapt SP by giving surgeons the ability to deliver a powerful bone formation agent to the precise location it is needed, without the concerns of off-target effects. There is a growing need for new options that produce anatomically precise bone and improved outcomes for patients. Alongside development for spinal fusion, OsteoAdapt SP is being studied in a range of other spinal conditions as well as separate indications in dental, sports medicine, and veterinary medicine.

Professor Ian Whittle, MD, PhD, Director of Research & Education at The International Spine Centre (3D Research@TISC), Australia, commented: “OsteoAdapt SP has the potential to transform the way we treat degenerative spinal diseases. At The International Spine Centre we have pioneered an individualized and patient-centric approach to spinal surgery, and we welcome this unique opportunity to be the first international location in Theradaptive’s clinical trial program, and the chance to bring this important new treatment to Australian patients.”

Dr YH Yau, FRCSEd (Neurosurgeon), FRACS, Clinical Director & Co-Founder at The International Spine Centre will be the lead surgeon and PI for the study. He comments that “Whilst only a small proportion of people with spinal conditions are indicated for any form of fusion surgery, the opportunity to perform this surgery well and to achieve excellent and safe bone fusion is very encouraging.”

This initial feasibility study, marking the first ever clinical study for OsteoAdapt SP, will commence in April and will recruit 80 patients from sites in Australia and the U.S. The purpose of the study is to assess the safety and effectiveness of OsteoAdapt SP as a replacement for the current surgical standard of care and identify the most appropriate OsteoAdapt SP dose to be investigated in a future pivotal study. More details can be found at ClinicalTrials.gov identifier NCT06154005.

Australia as a global clinical trial destination
John Greenbaum, SVP of Regulatory & Clinical Affairs at Theradaptive, said: “Australia has a global reputation for high-quality research and a long history of contributing to the advancement of spinal surgical knowledge and technologies. With a flexible and streamlined regulatory system that is closely aligned with the U.S. system, we can deliver robust global clinical trials for OsteoAdapt SP in a cost and time-efficient way.”

For U.S. companies initiating early clinical trials, Australia is a particularly attractive trial location. Recent research suggests that before tax incentives, clinical trials in Australia are 28% more cost-effective than in the U.S., rising to 60% more cost-effective after-tax incentives.2 The benefits of Australia as a trial destination go beyond the financial, and include world-class research teams, state-of-the-art infrastructure and facilities and a global reputation for high-quality clinical research.

Theradaptive’s therapeutic platform creates material-binding variants of recombinant therapeutic proteins that bind to medical devices, implants, and injectable carriers. By enabling anatomically precise and locally-sustained therapeutic delivery, the platform aims to improve the efficacy and safety of current treatments on the market. Theradaptive’s unprecedented three Breakthrough Medical Device Designations from the U.S. Food and Drug Administration (FDA) reinforce the groundbreaking nature of this new approach and its potential for the treatment of degenerative spinal diseases.

A future of expansion is good news for Frederick, Maryland
Theradaptive CEO and founder Luis Alvarez, PhD, said “The decision by the Bellberry Ethics Committee represents a significant milestone for Theradaptive as it signals an acceleration of our transition to a clinical-stage organization and our ambitions for global expansion in order to bring OsteoAdapt SP to patients around the world. We are about to embark on a period of growth that will transform our operations here in Maryland and internationally and we are actively seeking the best talent in the industry to join our world-class team at this exciting time for Theradaptive.”

About Theradaptive
Founded in 2016 and headquartered in Frederick, Maryland, U.S., Theradaptive is a venture-backed medical device company, with the goal of leveraging its therapeutic protein delivery platform to deliver biologics where they are needed in the body, with high local precision and high persistence, to address unmet medical needs. Theradaptive’s innovative platform is enabling the development of new protein therapeutics in spine, orthopedics, and soft tissue repair, as well as targeted immuno-oncology.

In October 2023, Theradaptive received a U.S. Defense (DOD) Clinical Trial Award of $7.4M, designed to support the continued development and scale up of OsteoAdapt SP production for clinical trials. This was awarded through the Peer Reviewed Medical Research Program under Award No. HT9425-23-1-0693. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Assistant Secretary of Defense for Health Affairs or the Department of Defense.

References
1.    Intergenerational Report 2023: Australia’s future to 2063. Australian Government. August 2023. https://treasury.gov.au/sites/default/files/2023-08/p2023-435150.pdf
2.    Australia: Preferred Destination for Early Phase Clinical Trials. A Frost & Sullivan White Paper. 2016. https://novotech-cro.com/sites/default/files/2022-03/australia-preferred-destination-early-phase-clinical-trials.pdf

Media Contact
Serena Lertora, Theradaptive, 240-397-4082, Serena.lertora@theradaptive.com 

SOURCE Theradaptive