FreeOx's Ox-01 Outperforms 3 Candidates from Big Pharma; Phase 2/3 Expected to Initiate in 2025
BARCELONA / PALO ALTO, Spain, Nov. 15, 2024 /PRNewswire-PRWeb/ -- FreeOx Biotech, a clinical stage biopharmaceutical company pioneering the development of a novel drug class for Acute Ischemic Stroke (AIS), today announced that its lead compound, Ox-01, has been officially selected by the National Institute of Neurological Disorders and Stroke (NINDS) to be evaluated on its new stroke-dedicated STEP clinical platform (StrokeNet Thrombectomy Endovascular Platform).
After rigorous evaluation Ox-01 was selected for the prestigious Stroke-dedicated STEP platform to enter its 2-stage process, the end result of which is initiation of a Phase 2/3 trial, expected in 2025. Ox-01 singularly qualified for Stage 1, based on results obtained during the SPAN (Stroke Pre-Clinical Assessment Network) translational trial. Stage 2 requires approval of Ox-01's Phase 2/3 protocol design, which is currently under discussion with the US Food and Drug Administration (FDA).
Emmett-Phil Coriat, Chairman and CEO of FreeOx Biotech, stated, "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. The NINDS funding will accelerate our efforts to bring this promising mechanical thrombectomy adjunctive treatment to patients who most desperately need new options."
SPAN (Stroke Preclinical Assessment Network) was established in 2018 as a groundbreaking and prestigious program for evaluating stroke treatments. In this comparative translational trial conducted by NINDS, Ox-01 emerged as the sole candidate to achieve distinction. The trial's significance was underscored by its large scale, involving 2,615 subjects and utilizing a novel animal model developed by NINDS over 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 the efficacy threshold. This remarkable achievement, announced at the International Stroke Conference in February 2023, not only demonstrated Ox-01's potential but also secured its position as the first candidate selected for advancement to Stage 1 of the STEP (StrokeNet Thrombectomy Endovascular Platform) program.
This groundbreaking selection marks a significant milestone in stroke treatment research, as FreeOx's Phase 2/3 AURORA trial (Administration of URic acid to Optimize Reperfusion Adequacy in Acute Stroke Trial) will be funded by NINDS, amplifying the potential of Ox-01 to revolutionize stroke care. The STEP program, established by NINDS in 2022, aims to rapidly advance interventions that improve outcomes for AIS patients with Large Vessel Occlusions (LVOs) treated with thrombectomy. LVOs are ischemic strokes with the highest mortality and the most serious health consequences.
Dr. Ángel Chamorro, FreeOx founder and Director of the Comprehensive Stroke Center
at Hospital Clinic Barcelona, explained, "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. The SPAN study, conducted with the utmost methodological rigor, 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 US that could significantly improve outcomes for stroke patients." Dr. Chamorro has published numerous papers identifying Uric Acid's potential in stroke treatment.
The AURORA trial builds on the remarkable results of Ox-01 seen in a subpopulation of Mechanical Thrombectomy-treated patients during a Phase 2b trial involving 421 patients, and on its performance in SPAN. These results give Ox-01 an edge in the race for neuroprotection and cerebral reperfusion enhancement.
Both SPAN and STEP represent cutting-edge initiatives by NINDS in stroke research, aiming to revolutionize treatment options and improve patient outcomes and address a critical need in large vessel occlusion stroke treatment investigation. STEP is integrated within the NIH StrokeNet, leveraging its infrastructure to conduct clinical trials. Together, these programs, resulting from focused NINDS investments over the last 10 years, aim to accelerate the development of effective stroke treatments, potentially transforming patient care.
According to Martin Dieck, Managing Partner of Neuro Technology Investors, "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. It is important to understand how little progress has been achieved in neuro-protective 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 NINDS and the broader medical community to bring Ox-01 to patients and potentially transform the standard of care in stroke treatment."
NTI or Neuro Technology Investors recently made a significant investment in the company 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 United States as it moves forward with this critical research. The investment from NTI, coupled with the NINDS selection, positions FreeOx Biotech for rapid advancement in its mission to transform stroke treatment.
Also joining the round was CS Group, an investment group from Sunnyvale, California.
About NTI
Neurotechnology Investors is composed of physicians from around the world with backgrounds in neurosurgery, neurology, and several vascular specialties. NTI draws on the collective knowledge of its membership to identify, invest, and provide operational expertise for promising medical technologies along their development lifecycle, from concept through commercialization. To learn more, please visit www.themdadvantage.com.
About CS Group：
CS Group is a global investment company that invests in early stage companies engaged in development of medical technologies, medical devices, healthcare information technology and health care services.
About NINDS:
The National Institute of Neurological Disorders and Stroke (NINDS) is part of the U.S. National Institutes of Health (NIH) and aims to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease.
About FreeOx Biotech:
FreeOx Biotech is a clinical-stage biopharmaceutical company dedicated to developing Cerebrovascular Protective Therapy, a new drug class for the emergency treatment of Acute Ischemic Stroke (AIS) patients. By focusing on restoring microcirculation homeostasis and enhancing penumbra reperfusion, FreeOx Biotech aims to revolutionize stroke care and improve patient outcomes. FreeOx' s Ox-01, based on a proprietary co-crystal of uric acid with composition of matter protection, is in development as an emergency Adjunct Mechanical Thrombectomy Therapy for Acute Ischemic Stroke (AIS.). FreeOx is building a pipeline based on another proprietary liposomal formulation technology that broadly expands opportunities in neurology. Founded by Dr. Ángel Chamorro, MD, a leading stroke neurologist and pioneer in the use of Uric Acid as an emergency treatment for AIS, FreeOx 's novel adjunct drug has been shown to reperfuse the brain microcirculation. By contrast, current emergency AIS treatments are effective only in addressing recanalization (macrocirculation restoration).
Contact:
Emmett-Phil Coriat
Chairman & CEO
Media Contact
Emmett-Phil Coriat, FreeOx Biotech, 1 7143104439, [email protected], https://freeoxbiotech.com/
SOURCE FreeOx Biotech; FreeOx Biotech
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