Regulated information – Inside information Despite Prior Positive Data, THR-149 Did Not Demonstrate Improvement in Vision Oxurion’s Board has Decided to Take Necessary Steps to File for Bankruptcy Leuven, BELGIUM, Boston, MA, US – November 20, 2023 – 7:00 am CET – Oxurion NV (Euronext Brussels: OXUR) a biopharmaceutical company announced today that topline data in its KALAHARI Phase 2, Part B clinical trial for diabetic macular edema (DME) (KALAHARI trial) did not demonstrate that its novel PKal Inhibitor, THR-149, improved vision as much as the comparator, the anti-VEGF therapy aflibercept, at Month 3 (the primary endpoint).

受监管的信息-内部信息尽管之前有积极的数据，但THR-149并未显示视力改善Oxurion董事会已决定采取必要措施申请破产比利时鲁汶，马萨诸塞州波士顿-2023年11月20日至7:00 CET-Oxurion NV（Euronext Brussels:OXUR）一家生物制药公司今天宣布，其卡拉哈里第二阶段的顶级数据，B部分糖尿病性黄斑水肿（DME）临床试验（KALAHARI试验）未证实其新型PKal抑制剂THR-149在第3个月时与对照组抗VEGF治疗aflibercept一样改善视力（主要终点）。

The mean change in best corrected visual acuity (BCVA) from baseline at Month 3 was -0.2 letters for the THR-149 arm and +3.5 letters for the aflibercept arm. The results confirmed that THR-149 was safe and well tolerated. The KALAHARI trial is the only ongoing trial sponsored by Oxurion. In light of these results and the Company’s low cash position, the Company has therefore decided to take the necessary steps to file for bankruptcy.

最佳矫正视力（BCVA）从第3个月的基线平均变化为THR-149组为-0.2个字母，阿柏西普组为+3.5个字母。结果证实THR-149安全且耐受性良好。KALAHARI试验是Oxurion赞助的唯一正在进行的试验。鉴于这些结果和公司的低现金状况，公司因此决定采取必要步骤申请破产。

Oxurion’s investigators over-enrolled the trial with a total of 112 patients, for whom the current standard of care is suboptimal in treating their DME, reflecting the strong interest of both investigators and patients. The KALAHARI trial evaluated Oxurion’s novel plasma kallikrein (PKal) inhibitor THR-149 as a potential treatment for DME patients who respond suboptimally to anti-VEGF therapy.

Oxurion的研究人员对总共112名患者进行了试验，目前的护理标准在治疗DME方面并不理想，反映了研究者和患者的强烈兴趣。KALAHARI试验评估了Oxurion的新型血浆激肽释放酶（PKal）抑制剂THR-149作为对抗VEGF治疗反应欠佳的DME患者的潜在治疗方法。

The continuation of the trial followed the recommendation from an Independent Data Monitoring Committee (IDMC) in December 2022 that it would not be futile for the KALAHARI trial to continue based on the outcome of a pre-specified futility analysis that included an evaluation of interim efficacy and safety data from 31 pat.

试验的继续遵循了2022年12月独立数据监测委员会（IDMC）的建议，即根据预先指定的无效分析的结果继续进行KALAHARI试验并非徒劳，其中包括对中期疗效的评估来自31 pat的安全性数据。

Attachment

附件

EN

ZH