Ad Hoc Announcement Pursuant to Art. 53 LR Geneva, Switzerland, April 29, 2024 - Addex Therapeutics (SIX and Nasdaq: ADXN), a clinical-stage biopharmaceutical company focused on developing a portfolio of novel small molecule allosteric modulators for neurological disorders, today announced top-line data from a Phase 2 epilepsy study evaluating adjunctive ADX71149 (JNJ-40411813) administration in patients with focal onset seizures with suboptimal response to levetiracetam or brivaracetam.

根据2024年4月29日瑞士日内瓦LR第53条的特别公告-临床阶段生物制药公司Addex Therapeutics（SIX和Nasdaq:ADXN）专注于开发用于神经系统疾病的新型小分子变构调节剂组合，今天宣布了一项2期癫痫研究的顶级数据，该研究评估了对左乙拉西坦或布利伐拉西坦反应不佳的局灶性癫痫发作患者的辅助ADX71149（JNJ-40411813）给药。

The Phase 2 study did not achieve statistical significance for the primary endpoint of time for patients to reach baseline seizure count when ADX71149 was added to standard of care. “While disappointed that the Phase 2 ADX71149 epilepsy study did not meet the primary endpoint, we are still analyzing the data,” said Roger Mills, Chief Medical Officer of Addex.

当ADX71149被添加到标准护理中时，第二阶段研究对于患者达到基线癫痫发作计数的主要时间终点没有统计学意义。Addex首席医疗官罗杰·米尔斯（RogerMills）表示：“虽然对第二阶段ADX71149癫痫研究未达到主要终点感到失望，但我们仍在分析数据。”。

“We will provide details on data from the full study when this analysis is completed and will work with our partner to determine next steps for the ADX71149 program.” The data were reported from a total of 110 evaluable patients, who each received either 50 mg or 100 mg of ADX71149 twice daily (100 mg or 200mg twice daily, respectively, for patients receiving CYP3A4 inducing anti-seizure medication) in addition to their standard dose of levetiracetam or brivaracetam and up to three other anti-seizure drugs.

“当这项分析完成时，我们将提供完整研究数据的详细信息，并将与我们的合作伙伴合作，确定ADX71149计划的下一步。”这些数据来自总共110名可评估患者，除了标准剂量的左乙拉西坦或布利伐拉西坦以及多达三种其他抗癫痫药物外，他们每人每天两次接受50 mg或100 mg ADX71149（对于接受CYP3A4诱导的抗癫痫药物的患者，每天两次分别为100 mg或200mg）。

Adjunctive administration of ADX71149 was safe and well tolerated. “While this is disappointing news for us and our partner, Janssen, we remain focused on advancing the rest of our portfolio of allosteric modulator programs towards clinical studies,” said Tim Dyer, CEO of Addex. “In particular, we are making great progress in our GABAB PAM collaboration with Indivior, which is on track to select drug candidates for IND enabling .

ADX71149的辅助给药是安全且耐受性良好的。Addex首席执行官蒂姆·戴尔（TimDyer）表示：“虽然这对我们和我们的合作伙伴杨森（Janssen）来说是一个令人失望的消息，但我们仍然专注于将变构调节剂项目组合的其余部分推向临床研究。”。“特别是，我们在GABAB-PAM与Indivior的合作方面取得了很大进展，Indivior正在为IND选择候选药物。