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.
專注於開發治療神經系統疾病的新型小分子變構調節劑組合的臨床階段生物製藥公司Addex Therapeutics（納斯達克股票代碼：ADXN）今天公佈了一項2期癲癇研究的主要數據，該研究評估了對左乙拉西坦或布利伐拉西坦反應不佳的局竈性發作性癲癇患者的輔助給藥 ADX71149（JNJ-40411813）。在將 ADX71149 添加到標準護理時，對於患者達到基線發作次數的主要終點，2 期研究沒有達到統計學意義。
"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首席醫學官羅傑·米爾斯說：“儘管對第二階段 ADX71149 癲癇研究未達到主要終點感到失望，但我們仍在分析數據。”“分析完成後，我們將提供全面研究數據的詳細信息，並將與我們的合作伙伴合作確定 ADX71149 計劃的下一步行動。”
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.
這些數據來自總共 110 名可評估患者，除了標準劑量的左乙拉西坦或布利伐拉西坦以及最多三種其他抗癲癇藥物外，他們每人每天兩次接受 50 毫克或 100 毫克的 ADX71149（對於接受 CYP3A4 誘發抗癲癇藥物的患者，每天分別服用 100 毫克或 200 毫克）。ADX71149 的輔助給藥是安全的，耐受性良好。
譯文內容由第三人軟體翻譯。