Bioxodes, a clinical stage biotech company developing a potential best-in-class antithrombotic agent for acute cardiovascular setting, announces today that the Belgian Federal Agency for Medicines and Healthy Products (FAMHP), together with the designated Ethics Committee, have authorized the initiation of a double blind, placebo controlled, single ascending dose phase I trial with its candidate, Ir-CPI, in healthy male volunteers. The objectives of this phase I study are to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of the drug candidate, Ir-CPI. The clinical trial has already been launched in Belgium, early October. “The launch of this phase I clinical trial with Ir-CPI is a major milestone for the recognition by the regulatory authorities of the quality of the data generated by our team,” said Edmond Godfroid, CEO of Bioxodes. “We are eager to learn more about Ir-CPI in the clinic after obtaining very encouraging preclinical activity and safety profile of our lead product, soon to be published in the renowned journal JACC.” “This publication clearly validates the scientific results of Bioxodes, emphasizing their relevancy and scientific interest. It represents a tremendous support for the ongoing clinical studies” said the KOL Prof. Cédric Hermans, Head of Haemostasis and Thrombosis at St-Luc University Hospital, Brussels, Belgium.

Since its setup in 2013, Bioxodes has been developing its lead program based on the Ir-CPI molecule. Ir-CPI is the first candidate in a novel class of antithrombotics and potentially the first injectable molecule with limited risk of bleeding and without the need to be reversed or washed out at the end of critical cardiovascular procedures. Ir-CPI has the potential to be used in several populations of patients. The company has so far successfully raised €21.25M from Belgian investment funds and Business Angels, including €7.5M of non-dilutive funding from the Walloon Region. Bioxodes owns issued and pending patents related to Ir-CPI in the EU and US.

Clinical practice shows that the main unmet need in the field of thrombosis prevention is the availability of an antithrombotic therapy without bleeding risk. Thanks to its unique mode of action targeting both coagulation Factors XIIa and XIa, Ir-CPI is a promising alternative to current anticoagulants as deficiencies in these factors protect against thrombosis without causing spontaneous bleeding. Indeed, Ir-CPI has been proven to be as efficient as unfractionated heparin, the current gold standard, but devoid of bleeding risk, as shown in preclinical large animal models including a cardiopulmonary bypass. These results will soon be published in the Journal of the American College of Cardiology (Vol. 74/17 (2019) pp. 2178-2189). Ir-CPI is a potential best-in-class antithrombotic drug to replace unfractionated heparin in acute hospital cardiovascular setting.