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Addex Therapeutics | 6-K: Report of foreign private issuer [Rules 13a-16 and 15d-16]

Addex Therapeutics | 6-K: Report of foreign private issuer [Rules 13a-16 and 15d-16]

Addex Therapeutics | 6-K:外國發行人報告
美股SEC公告 ·  2024/07/22 18:07

牛牛AI助理已提取核心訊息

Addex Therapeutics announced that Janssen Pharmaceuticals (J&J Innovative Medicine) has discontinued the development of ADX71149 in epilepsy following unsuccessful Phase 2 trial results. The April 2024 top-line data showed that ADX71149 as an adjunctive treatment failed to achieve statistical significance in patients with focal onset seizures who had suboptimal response to standard therapies.The partnership between Addex and Janssen remains active while they analyze the complete Phase 2 dataset. Under their collaboration agreement, Addex is eligible for up to €109 million in development and regulatory milestone payments, plus low double-digit royalties on net sales. ADX71149, a selective metabotropic glutamate subtype 2 receptor positive allosteric modulator, was evaluated in a multi-center study focusing on its efficacy when combined with levetiracetam or brivaracetam.The study was conducted in two parts: a 4-week acute efficacy phase followed by an 8-week maintenance phase for qualifying patients. The primary endpoint measured the time for patients to reach baseline seizure count when ADX71149 was added to standard care.
Addex Therapeutics announced that Janssen Pharmaceuticals (J&J Innovative Medicine) has discontinued the development of ADX71149 in epilepsy following unsuccessful Phase 2 trial results. The April 2024 top-line data showed that ADX71149 as an adjunctive treatment failed to achieve statistical significance in patients with focal onset seizures who had suboptimal response to standard therapies.The partnership between Addex and Janssen remains active while they analyze the complete Phase 2 dataset. Under their collaboration agreement, Addex is eligible for up to €109 million in development and regulatory milestone payments, plus low double-digit royalties on net sales. ADX71149, a selective metabotropic glutamate subtype 2 receptor positive allosteric modulator, was evaluated in a multi-center study focusing on its efficacy when combined with levetiracetam or brivaracetam.The study was conducted in two parts: a 4-week acute efficacy phase followed by an 8-week maintenance phase for qualifying patients. The primary endpoint measured the time for patients to reach baseline seizure count when ADX71149 was added to standard care.
Addex Therapeutics宣佈,強生製藥(J&J創新醫學)已停止對ADX71149在癲癇中的開發,因爲第二階段試驗結果不理想。2024年4月的初步數據表明,ADX71149作爲輔助治療未能在對標準治療反應不佳的局部發作癲癇患者中達到統計顯著性。Addex與強生的合作關係仍在繼續,他們正在分析完整的第二階段數據集。根據他們的合作協議,Addex有資格獲得高達€10900萬的開發和監管里程碑付款,以及淨銷售額的低雙位數特許權使用費。ADX71149是一種選擇性代謝型穀氨酸亞型2受體正變構調節劑,在一項多中心研究中評估了其與拉莫三嗪或布拉維巴侖聯合使用時的療效。該研究分爲兩部分進行:爲期4周的急性有效性階段,隨後是針對符合條件患者的8周維持階段。主要終點是測量在標準護理中加入ADX71149後,患者達到基線癲癇發作次數所需的時間。
Addex Therapeutics宣佈,強生製藥(J&J創新醫學)已停止對ADX71149在癲癇中的開發,因爲第二階段試驗結果不理想。2024年4月的初步數據表明,ADX71149作爲輔助治療未能在對標準治療反應不佳的局部發作癲癇患者中達到統計顯著性。Addex與強生的合作關係仍在繼續,他們正在分析完整的第二階段數據集。根據他們的合作協議,Addex有資格獲得高達€10900萬的開發和監管里程碑付款,以及淨銷售額的低雙位數特許權使用費。ADX71149是一種選擇性代謝型穀氨酸亞型2受體正變構調節劑,在一項多中心研究中評估了其與拉莫三嗪或布拉維巴侖聯合使用時的療效。該研究分爲兩部分進行:爲期4周的急性有效性階段,隨後是針對符合條件患者的8周維持階段。主要終點是測量在標準護理中加入ADX71149後,患者達到基線癲癇發作次數所需的時間。

譯文內容由第三人軟體翻譯。


牛牛AI助手部分由第三方人工智慧模型基於資訊內容自動產生。


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