French Biotech Candidate For Cannabis Use Disorder Fails Phase 2B Clinical Trial, Indivior Will Not Exercise Option
French Biotech Candidate For Cannabis Use Disorder Fails Phase 2B Clinical Trial, Indivior Will Not Exercise Option
AEF0117 was well tolerated, and no safety concerns were observed. The type and frequency of adverse events were similar across all treatment groups including placebo.French biotechnology company specializing in the treatment of brain disorders Aelis Farma reported Wednesday the results from its clinical Phase 2B trial with AEF0117, evaluating the efficacy and safety in treatment-seeking participants with moderate to severe cannabis use disorder (CUD).
專門治療腦部疾病的法國生物技術公司 Aelis Farma 週三報告了其針對 AEF0117 的20期臨床試驗結果，該試驗評估了中度至重度大麻使用障礙（CUD）尋求治療的參與者的療效和安全性。
The study did not meet its main goal, which was to reduce participants' cannabis use to one day or less per week. It also failed to meet other goals, such as getting participants to stop using marijuana completely or reduce their consumption to two days or less per week.
該研究沒有實現其主要目標，即將參與者的大麻使用量減少到每週一天或更少。它也未能實現其他目標，例如讓參與者完全停止使用大麻或將其消費量減少到每週兩天或更短的時間。
"It is noteworthy that there was a very low placebo effect for these endpoints, suggesting that CUD participants in this study may be resistant to change the number of days per week of use," Aelis Farma said in a press release.
Aelis Farma在一份新聞稿中說：「值得注意的是，這些終點的安慰劑效應非常低，這表明這項研究的CUD參與者可能對改變每週使用天數有抵抗力。」
AEF0117 was well tolerated, and no safety concerns were observed. The type and frequency of adverse events were similar across all treatment groups including placebo.
AEF0117 耐受性良好，未觀察到任何安全問題。包括安慰劑在內的所有治療組的不良事件的類型和頻率都相似。
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Indivior Rethinks Exercising Option
Indivior 重新考慮行使期權
This clinical Phase 2B study is part of the strategic collaboration between Aelis Farma and Indivior PLC (NASDAQ:INDV), which includes an exclusive option for Indivior to license the global rights to AEF0117. Following the results announcement, the U.K.-basedglobal pharmaceutical company focused on developing medicines to treat substance use disorders (SUD) and serious mental illnesses provided an update on the option.
這項20期臨床研究是Aelis Farma與Indivior PLC（納斯達克股票代碼：INDV）戰略合作的一部分，其中包括Indivior獲得 AEF0117 全球版權許可的獨家選擇權。業績公佈後，這家總部位於英國的專注於開發治療藥物濫用障礙（SUD）和嚴重精神疾病的藥物的全球製藥公司提供了該選項的最新情況。
"Given the lack of separation from placebo on primary and secondary endpoints and before seeing further additional favorable clinical data, Indivior does not currently expect to exercise its option," Indivior stated.
Indivior表示：「鑑於在主要和次要終點上缺乏與安慰劑的分離，在看到更多有利的臨床數據之前，Indivior目前預計不會行使選擇權。」
In 2021, Indivior and Aelis Farma announced a strategic collaboration that includes an exclusive option and license agreement for the global rights to AEF0117, a first-in-class synthetic signaling specific inhibitor engineered to inhibit the cannabinoid type 1 receptor. Indivior paid $30 million for the option to license the candidate.
2021 年，Indivior 和 Aelis Farma 宣佈了一項戰略合作，其中包括對 AEF0117 全球版權的獨家期權和許可協議，這是一種專爲抑制 1 型大麻素受體而設計的同類首創合成信號特異性抑制劑。Indivior支付了3000萬美元購買了向候選人發放許可的期權。
Price Action
價格走勢
Indivior shares traded down 0.25% at $12.14 per share at market close Wednesday.
週三收盤時，Indivior股價下跌0.25％，至每股12.14美元。
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