Johnson & Johnson-Partnered Addex Therapeutics' Epilepsy Candidate Fails Mid-Stage Study, Stock Tanks
Johnson & Johnson-Partnered Addex Therapeutics' Epilepsy Candidate Fails Mid-Stage Study, Stock Tanks
Monday, Addex Therapeutics (NASDAQ:ADXN) released 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.
週一，Addex Therapeutics（納斯達克股票代碼：ADXN）發佈了一項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西坦反應不佳的局竈性發作性癲癇患者的輔助 ADX71149（JNJ-40411813）給藥。
The company is collaborating with Johnson & Johnson's (NYSE:JNJ) Janssen Pharmaceuticals Inc.
該公司正在與強生（紐約證券交易所代碼：JNJ）詹森製藥公司合作。
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 the standard of care.
當將 ADX71149 添加到護理標準時，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.
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。”
"We will provide details on data from the full study when this analysis is completed and will work with our partner to determine the next steps for the ADX71149 program," Mills added.
米爾斯補充說：“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.
這些數據來自總共 110 名可評估的患者，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，分別爲 100 毫克或 200 毫克）。
Adjunctive administration of ADX71149 was safe and well tolerated.
ADX71149 的輔助給藥是安全的，耐受性良好。
"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 toward 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 studies in June this year for substance use disorder and chronic cough programs."
Addex首席執行官蒂姆·戴爾表示：“儘管這對我們和我們的合作伙伴詹森來說都是令人失望的消息，但我們仍然專注於將變構調節劑項目的其餘組合推進到臨床研究。”“特別是，我們在GABAB PAM與Indivior的合作方面取得了長足的進展，Indivior有望在今年6月爲藥物濫用障礙和慢性咳嗽項目的IND支持研究選擇候選藥物。”
Price Action: ADXN shares are down 50.4% at $7.99 at the last check Monday.
價格走勢：在週一的最後一次檢查中，ADXN股價下跌50.4％，至7.99美元。
PublicDomainPictures from Pixabay
來自 Pixabay 的公共域名圖片
譯文內容由第三人軟體翻譯。