First-in-class drug candidate evaluated in first eight patients Gosselies (Belgium), June 27, 2024 – Bioxodes SA, a clinical stage biopharmaceutical company developing novel therapies for the prevention and treatment of thrombotic and inflammatory diseases, announces today that it has enrolled the first eight of 32 patients in a Phase 2a clinical study of its lead asset BIOX-101 (Ir-CPI).

2024年6月27日，在前八名患者中评估的一流候选药物Gosselies（比利时）——Bioxodes SA，一家临床阶段的生物制药公司，开发用于预防和治疗血栓性和炎性疾病的新型疗法，今天宣布，它已经将32名患者中的前八名纳入其主要资产BIOX-101（Ir CPI）的2a期临床研究。

The study is evaluating BIOX-101 in intracerebral hemorrhagic stroke (ICH), a devastating condition for which there is currently no available treatment. Reaching this first milestone allows Bioxodes to conduct an initial analysis of pharmacokinetic and pharmacodynamic data to evaluate the dose-response and preliminary clinical proof-of concept of the therapeutic candidate, as well as safety in this patient population.

该研究正在评估BIOX-101在脑出血性中风（ICH）中的作用，ICH是一种破坏性疾病，目前尚无可用的治疗方法。达到这第一个里程碑可以使Bioxodes对药代动力学和药效学数据进行初步分析，以评估治疗候选药物的剂量反应和初步临床概念证明，以及该患者群体的安全性。

“For the first time, we are able to assess the preliminary results of BIOX-101 in ICH patients, who up until now have had very few treatment options. Analysis of these first 8 patients will yield preliminary proof-of-concept data for BIOX-101, a first-in-class drug candidate derived from a protein found in the saliva of the tick 1, designed to prevent the harmful secondary brain injuries that occur after a hemorrhagic stroke,” said Marc Dechamps, Chief Executive Officer at Bioxodes.

Bioxodes首席执行官马克·德尚（MarcDechamps）说：“我们首次能够评估BIOX-101在ICH患者中的初步结果，到目前为止，ICH患者的治疗选择很少。对前8名患者的分析将产生BIOX-101的初步概念验证数据，BIOX-101是一种一流的候选药物，来自蜱1唾液中的一种蛋白质，旨在预防出血性中风后发生的有害继发性脑损伤。”。

The study, conducted in 10 stroke units in Belgium and led by Prof Robin Lemmens, a world-leading stroke authority and head of the clinic at the University Hospital Leuven, aims to enroll 32 patients aged 18 and above, with 24 receiving BIOX-101, and 8 standard-of-care treatment. The trial is a randomized, open-label proof-of-concept study, and will evaluate the safety and tolerability of BIOX-101 in patients with spontaneous ICH, while also generating preliminary data on secondary efficacy .

。该试验是一项随机，开放标签的概念验证研究，将评估BIOX-101在自发性ICH患者中的安全性和耐受性，同时还将产生有关次要疗效的初步数据。