Planned Phase III for Ox-01 to Begin in AIS in Early 2025
Pivotal Trial to Evaluate Novel Adjunct Drug for Mechanical Thrombectomy
FreeOx Biotech SL, a late-stage clinical biopharmaceutical company pioneering the development of a novel drug class for Acute Ischemic Stroke (AIS), announced today the formal launch of a seed round to advance the company’s novel stroke drug into Phase III clinical development. Simultaneously, FreeOx said it had successfully completed a first close of €1.7 million from investors in Canada, the U.S., Spain, and Israel. The company has compelling Phase II data and plans to initiate a Phase III registrational trial of its first novel adjunct drug to be used in mechanical thrombectomy (MT) in AIS where reperfusion challenges exist despite positive outcomes in this modality. FreeOx has strong intellectual property covering Uric Acid and its use in stroke treatment.
According to Chairman of the Board and Chief Executive Officer Emmett-Phil Coriat, “The endorsement of Uric Acid (UA), the active ingredient in Ox-01, our Phase III-ready investigational drug by the National Institutes of Health, NINDS’ SPAN (Stroke Preclinical Assessment Network), is central to our confidence in moving forward. As reported in SCIENCE TRANSLATIONAL MEDICINE (www.spannetwork.org), Uric Acid was the only one of five interventional drug candidates for which
data supported further clinical evaluation, as it demonstrated unprecedented efficacy compared to the others. As such, the NINDS indicated potential interest in funding Ox-01’s Phase III trial. “The NINDS’ advocacy underscores their confidence in the efficacy and potential of Ox-01 as a ground-breaking adjunct therapy in MT for AIS. We are confident that Ox-01 will significantly reduce disability in AIS patients.” Coriat added that that the company’s fundraising target was a total
investment of €5 million and that the initial €1.7 million will be used primarily to advance FreeOx Biotech’s lead product, Ox-01 to a Phase III registrational trial in the U.S. In addition to the pharmaceutical grade Uric Acid active ingredient in Ox-01, FreeOx is building a pipeline based on a proprietary liposomal formulation technology that broadly expands opportunities in neurology.
Stroke is the leading cause of disability worldwide, according to the American Stroke Association. While advances have been made with mechanical thrombectomy, significant unmet needs exist when 50 percent of Large Vessel Occlusion patients have insufficient restoration of their microcirculation and ensuing disabilities.
For more information about FreeOx Biotech and its groundbreaking stroke treatment technology, please visit the company’s website.
About FreeOx Biotech
FreeOx Biotech is a leading late-stage 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 lead product, Ox-01, is Phase III- ready. FreeOx is building a pipeline based on a 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).
Chairman & CEO