A preclinical trial by the U.S. National Institutes of Health validates the efficacy of Uric Acid for ischaemic stroke
15 Feb 2023
Phase 3Phase 2Clinical Result
Dr Ángel Chamorro and Carlos Lurigados, co-founders
of FreeOx Biotech, spin-out of the Hospital Clínic Barcelona
The National Institute of Neurological Disease and Stroke (NINDS) of the U.S. National Institutes of Health (NIH) created the Stroke Preclinical Assessment Network (SPAN) to preselect candidate molecules to be evaluated in clinical trials for neuroprotection in ischaemic stroke. Of the therapies evaluated in SPAN, only Uric Acid has shown efficacy.
The results of the study were presented at the International Stroke Conference held last week in Dallas.
Uric Acid is a neuroprotectant and cerebral reperfusion enhancer identified by Dr Ángel Chamorro at the Hospital Clínic Barcelona and transferred to FreeOx Biotech for its development as a drug, Ox-01, which has been granted a patent in the USA for its use in combination with Mechanical Thrombectomy in ischaemic stroke.
Uric Acid was shown to improve the prognosis of ischaemic stroke in a preclinical study carried out on rodents within the framework of the Stroke Preclinical Assessment Network (SPAN) in the USA, a network of experimental laboratories focusing on cerebral ischaemia, coordinated by the Keck School of Medicine of the University of Southern California (USC).
SPAN’s aim was to identify the most promising molecules for their subsequent assessment in pivotal phase III clinical trials funded by NINDS/NIH. After two years of preclinical experiments with six molecules, SPAN identified Uric Acid as the only effective treatment out of all the therapies evaluated in the different phases of the project.
Stroke is a disease with a very high social impact. It is estimated that one in four people over 25 will have a cerebrovascular accident in their lifetime, and each year over 12.2 million people have an ischaemic stroke worldwide.
During the first few hours after a stroke, it is crucial to act quickly, since on average two million brain cells die every minute. Therefore, treatments to restore blood flow should be used up to 24 hours after the stroke.
Uric Acid had already demonstrated clinical benefit in stroke patients treated with mechanical thrombectomy in a clinical trial led by Dr Ángel Chamorro, head of the IDIBAPS-Hospital Clínic Barcelona Cerebrovascular Pathology Unit, scientific advisor at FreeOx Biotech, Assistant Professor at the University of Iowa and participant in the SPAN network study. “The SPAN study was carried out in animal models of ischaemic stroke, in experimental conditions with the maximum methodological rigour, which positions Uric Acid and FreeOx in an advantageous position for the clinical validation of Ox-01 in an upcoming pivotal clinical trial in stroke patients treated with mechanical thrombectomy”, says Dr Chamorro.
Likewise, Dr Tudor Jovin, scientific co-founder of FreeOx Biotech, points out that “the SPAN results represent one of the most important findings in recent years in terms of identifying new treatments for ischaemic stroke”.
“The positive results of the preclinical study are a very important step to ensure Ox-01 reaches patients as soon as possible”, comments Carlos Lurigados, CEO of FreeOx Biotech.
The SPAN results were presented in a plenary session at the International Stroke Conference 2023 (ISC) held in Dallas on February 8-10.
Details of the session:
Pre-Clinical Translational Stroke Development: SPAN Results and Next Steps
Date: 10 February 2023
Time: 9.15 am – 10.45 am Local time (UTC -6)
About Ox-01
Ox-01 is an innovative drug based on uric acid, eliminating the high toxicity of peroxynitrite, increasing perfusion in the cerebral microcirculation and with a protective effect in preventing damage caused by reperfusion (intravenous thrombolysis or mechanical thrombectomy) after acute ischaemic stroke. No other product to date has succeeded in demonstrating these neuroprotective properties in two Phase II and Phase IIb clinical trials. Ox-01 was developed by the medical-scientific team led by Dr. Ángel Chamorro at the Hospital Clínic de Barcelona and, subsequently, transferred to FreeOx Biotech for its development and exploitation worldwide.
About FreeOx Biotech
FreeOx Biotech is a spin-out of the Hospital Clínic de Barcelona-IDIBAPS, which develops innovative drugs that act by reducing oxidative stress processes in the body, especially those related to the neurological and cardiovascular systems. The company was founded in 2017 by Ángel Chamorro, Carlos Lurigados, Ángel Honrado, Tudor G. Jovin and Joan Bigorra, and has been granted a patent in the USA for the use of Uric Acid in Stroke in combination with Mechanical Thrombectomy
More information: freeoxbiotech.com
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