Addex Therapeutics Announces Lack of Statistical Significance In ADX71149 Phase 2 Epilepsy Study
Addex Therapeutics Announces Lack of Statistical Significance In ADX71149 Phase 2 Epilepsy Study
Addex Therapeutics (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. 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.
专注于开发治疗神经系统疾病的新型小分子变构调节剂组合的临床阶段生物制药公司Addex Therapeutics（纳斯达克股票代码：ADXN）今天公布了一项2期癫痫研究的主要数据，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发作性癫痫患者的辅助给药 ADX71149（JNJ-40411813）。在将 ADX71149 添加到标准护理时，对于患者达到基线发作次数的主要终点，2 期研究没有达到统计学意义。
"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. "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."
Addex首席医学官罗杰·米尔斯说：“尽管对第二阶段 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。”“分析完成后，我们将提供全面研究数据的详细信息，并将与我们的合作伙伴合作确定 ADX71149 计划的下一步行动。”
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. Adjunctive administration of ADX71149 was safe and well tolerated.
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最多三种其他抗癫痫药物外，他们每人每天两次接受 50 毫克或 100 毫克的 ADX71149（对于接受 CYP3A4 诱发抗癫痫药物的患者，每天分别服用 100 毫克或 200 毫克）。ADX71149 的辅助给药是安全的，耐受性良好。