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).
法國生物技術公司Aelis Farma專注於治療腦部疾病，在其對 AEFl117 進行的臨床第二十億積分試驗中，於週三發佈了結果，評估了該藥物在尋求治療的中度至重度大麻成癮障礙(CUD)患者中的療效和安全性。
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.
該研究未達到其主要目標，即將參與者的大麻使用減少到每週一天或更少。它也沒有達到其他目標，比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少。
"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.
「值得注意的是，這些終點事件的安慰劑效應非常低，這表明在這項研究中，CUD參與者對改變每週使用天數可能具有抗性，」 Aelis Farma在新聞發佈中表示。
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.
AEFl117耐受性良好，並且沒有觀察到安全性問題。不良事件的類型和頻率在包括安慰劑在內的所有治療組中都相似。
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Indivior Rethinks Exercising Option
Indivior重新考慮行使選擇權
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.
這項臨床第二十億研究是Aelis Farma與Indivior PLC（納斯達克：INDV）之間的戰略合作的一部分，該合作包括Indivior獨家選擇權以獲得AEF0117的全球授權。在結果公告後，這家總部位於英國的全球製藥公司專注於開發用於治療物質使用障礙（SUD）和嚴重精神疾病的藥物提供了最新進展。
"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.
「在看到進一步的有利臨床數據之前，鑑於未能與安慰劑在主要和次要結局上有所區別，Indivior目前不打算行使其選擇權，」Indivior表示。
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宣佈進行戰略合作，其中包括全球權利的獨家選擇和許可協議，以獲取AEF0117的權益，這是一種首創的合成信號特異性抑制劑，用於抑制大麻素1型受體。Indivior支付了3000萬美元的選擇權費用。
Price Action
股價變動
Indivior shares traded down 0.25% at $12.14 per share at market close Wednesday.
截至週三收盤時，Indivior股票下跌0.25%，每股12.14美元。
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譯文內容由第三人軟體翻譯。
