Phase III-ready Ox-01 is the most advanced investigational drug in the FreeOx pipeline today. FreeOx has been granted a use patent covering Uric Acid with
MT in the US, South Korea and Australia. The company’s intellectual protection also covers its proprietary API synthesis GMP process, and pharmaceutical
product formulation process. FreeOx is also building a pipeline based on a proprietary liposomal formulation technology that broadly expands opportunities in neurology.
Ox-01 is a carefully engineered formulation of Uric Acid (UA), designed for a 90-minute IV infusion that can be administered before or during Mechanical Thrombectomy (MT). Uric Acid, an endogenous and inherently safe molecule, unleashes its potential by enhancing brain microcirculation and boosting penumbra reperfusion through a well understood, multi-modal mechanism of action. In a pre-assigned subgroup of a 421-patient pivotal multicenter double-blind randomized Phase IIb clinical trial (URICO-ICTUS), Ox-01 exhibited a remarkable 19% increase in patients achieving good outcomes, which translates to independent living. This achievement far surpasses the outcomes attained
with MT alone and even outperforms the outcomes achieved with rtPA as an adjunct to MT (a mere +3% to +7% improvement compared to Ox-01’s impressive +19%)
In a noteworthy milestone, at the 2023 International Stroke Conference, Uric Acid garnered special recognition from the National Institute of Neurological Disorders and Stroke (NINDS), earning its designation as the most promising MT adjunctive drug. Currently, FreeOx plans to advance Ox-01 to a pivotal Phase III clinical trial in the United States.
LipOx is a proprietary liposomal formulation technology based on Uric Acid.
What sets this formulation apart is its unique ability to induce superior drug characteristics (e.g., cross the blood-brain barrier), making it a versatile multi-product/multi indication platform for our future. The liposomal formulation is designed to customize a sustained release mechanism and a shift to simple IV injection, both ideal for non-emergency indications in neurology.
FreeOx is also building a pipeline based on the LipOx technology that broadly expands opportunities in neurology.