FreeOx Biotech has announced that its uric acid-based leading compound, Ox-01, has been officially selected by the US National Institute of Neurological Disorders and Stroke (NINDS) to be evaluated on its new stroke-dedicated StrokeNet Thrombectomy Endovascular Platform (STEP).
A FreeOx press release states that, after “rigorous evaluation”, Ox-01 was selected to enter STEP’s two-stage process—the end result of which is initiation of a Phase 2/3 trial, expected in 2025. Ox-01 singularly qualified for stage one based on results obtained during the Stroke Preclinical Assessment Network (SPAN) translational trial, while stage two requires approval of Ox-01’s Phase 2/3 protocol design, which is currently under discussion with the US Food and Drug Administration (FDA).
“Our team has been researching and developing this treatment for over 20 years, and this validation gives us the stamp of approval that we’ve been working towards,” said FreeOx founder and director Ángel Chamorro (Hospital Clinic Barcelona, Barcelona, Spain). “The SPAN study, conducted with the utmost methodological rigour, has positioned uric acid and FreeOx advantageously for the clinical validation study of Ox-01. We are excited to see this compound move forward in a Phase 2/3 clinical trial in the USA that could significantly improve outcomes for stroke patients.”
FreeOx’s recent release notes that SPAN was established in 2018 to evaluate stroke treatments. In this comparative, translational trial conducted by the NINDS, Ox-01 emerged as the sole candidate to achieve distinction. The trial involved 2,615 subjects and utilised a novel animal model developed by the NINDS over the course of a decade. Ox-01’s “exceptional performance” in SPAN set it apart from four other molecules, including three developed by major pharmaceutical companies, as it was the only compound to surpass a prespecified efficacy threshold.
This “remarkable achievement”, announced last year at the International Stroke Conference (ISC; 8–10 February 2023, Dallas, USA), not only demonstrated Ox-01’s potential but also secured its position as the first candidate selected for advancement to stage one of the STEP programme. This “groundbreaking selection” marks a “significant milestone” in stroke treatment research, FreeOx further claims.
The company’s Phase 2/3 AURORA trial will be funded by the NINDS, amplifying the potential of Ox-01 in stroke care, and is set to build on the results seen with Ox-01 in a subpopulation of mechanical thrombectomy-treated patients during a Phase 2b trial involving 421 patients—as well as its performance in SPAN.
“These results give Ox-01 an edge in the race for neuroprotection and cerebral reperfusion enhancement,” FreeOx states in its recent release.
The STEP programme, established by the NINDS in 2022, is aiming to rapidly advance interventions that improve outcomes for acute ischaemic stroke patients with large vessel occlusions (LVOs) treated via thrombectomy.
“This selection not only validates our innovative approach to stroke treatment based on 22 years of research, but also positions FreeOx at the forefront of a new era in stroke therapy,” commented FreeOx chairman and chief executive officer (CEO) Emmett-Phil Coriat. “The NINDS funding will accelerate our efforts to bring this promising mechanical thrombectomy-adjunctive treatment to patients who most desperately need new options.”
In addition, Neuro Technology Investors (NTI) recently made a significant investment in FreeOx and has joined its board of directors. This strategic funding further validates the potential of Ox-01 and strengthens FreeOx’s support from the neurology community in the USA as the company progresses its research, the release also notes. The NTI-led financing round was also joined by CS Group.
“The NINDS’ selection of Ox-01 represents a major stride in advancing stroke treatment research and underscores the potential of public-private partnerships in advancing medical innovations,” said NTI managing partner Martin Dieck. “It is important to understand how little progress has been achieved in neuroprotective therapies for stroke in the last several decades, with dozens of failed clinical trials—a context against which FreeOx Biotech steps into a leadership position in the field, committed to working closely with the NINDS and the broader medical community to bring Ox-01 to patients and potentially transform the standard of care in stroke treatment.”
