Neuropsychiatry-Focused Alto Neuroscience's Mid-Stage Depression Trial Disappoints, Analyst Notes Failure Raises Concerns About Platform
Neuropsychiatry-Focused Alto Neuroscience's Mid-Stage Depression Trial Disappoints, Analyst Notes Failure Raises Concerns About Platform
On Tuesday, Alto Neuroscience, Inc. (NYSE:ANRO) revealed that the Phase 2b study of ALTO-100 for major depressive disorder (MDD) did not meet its primary endpoint compared to placebo.
週二，Alto Neuroscience，Inc.（紐交所：ANRO）披露，ALTO-100用於重性抑鬱症（MDD）的第20億期研究未達到與安慰劑相比的主要終點。
The biomarker-defined major depressive disorder patient group treated with ALTO-100 did not demonstrate a statistically significant improvement in depressive symptoms compared to placebo.
接受ALTO-100治療的生物標誌物定義的重性抑鬱症患者群與安慰劑相比，並未顯示出在抑鬱症狀方面有顯著統計學改善。
ALTO-100 did not demonstrate a benefit over the placebo on the pre-specified key secondary analyses.
ALTO-100在預先指定的關鍵次生分析中並未顯示出相對於安慰劑的優勢。
Also Read: Treatment Patch For Schizophrenia: Newly Listed Alto Neuroscience Is Uniquely Positioned In Neuropsychiatry Landscape.
還閱讀：精神分裂症治療貼：新上市的Alto Neuroscience在神經精神病學領域具有獨特定位。
ALTO-100 continued to demonstrate a favorable safety and tolerability profile, with no new safety signals observed in this study compared to the previously completed clinical trials of ALTO-100.
與ALTO-100先前完成的臨床試驗相比，ALTO-100在這項研究中繼續顯示出有利的安全性和耐受性特徵，未觀察到新的安全信號。
- The most common adverse events from the trial related to treatment with ALTO-100 were headache, nausea, and abnormal dreams – all of which were experienced at similar rates to placebo.
- 與ALTO-100治療相關的試驗中最常見的不良事件包括頭痛、噁心和異常夢境，所有這些症狀發生率與安慰劑類似。
The company expects to complete an analysis of the full data set to determine the most appropriate next steps, if any, to further evaluate ALTO-100 in major depressive disorder.
公司預計完成對完整數據集的分析，以判斷是否有必要進一步評估ALTO-100在重性抑鬱症中的應用。
ALTO-100 is also being evaluated as an adjunctive treatment in a Phase 2b study for bipolar depression.
ALTO-100還正在進行第20億期雙相抑鬱症輔助治療研究。
The company expects its current cash position of $194 million to fund planned operations into 2027 and through multiple upcoming clinical readouts, including two additional readouts in major depressive disorder, with ALTO-203 and ALTO-300 expected in the first half of 2025.
公司預計其目前的19400萬美元現金儲備將支持計劃的運營直至2027年，並通過多次即將到來的臨床數據發佈，包括兩個附加臨床數據，其中ALTO-203和ALTO-300預計將於2025年上半年發佈。
William Blair notes that despite the setback with ALTO-100, which may raise concerns among investors about Alto's Precision Psychiatry Platform, the analysts do not consider this single failure to undermine the validity of their biomarker enrichment strategy.
William Blair指出，儘管ALTO-100出現了挫折，可能會引起投資者對Alto的精準精神病學平台產生擔憂，但分析師認爲這一單一失敗不會動搖其生物標誌物富集策略的有效性。
The analyst is now focused on the upcoming ALTO-300 Phase 2b results in major depressive disorder (MDD), anticipated in the first half of 2025, for further insights.
分析師目前關注的重點是2025年上半年預計公佈的主要抑鬱症(MDD)ALTO-300第20億階段結果，以獲取更多見解。
"While data points draw increased scrutiny on the biomarker stratification approach, historically placebo-controlled MDD studies have been high-risk, and this one appears no different. Still, in our discussions with management, it remained confident in the stratification approach, and we will await a fuller dataset to better understand this optimism despite the negative Phase 2b readout." William Blair analysts write.
「儘管數據點增加了對生物標記分層方法的審查，但歷史上的安慰劑對照MDD研究具有高風險，這一研究似乎也不例外。儘管如此，在與管理層的討論中，他們對分層方法仍然充滿信心，我們將等待更完整的數據集以更好地了解儘管階段20億結果不佳，但爲何仍然保持樂觀。」 William Blair分析師寫道。
The analyst maintains the Outperform rating.
分析師維持跑贏大盤評級。
Price Action: At last check on Wednesday, ANRO stock was down 67.70% to $4.70.
股票價格走勢：截至週三最新數據顯示，ANRO股票下跌了67.70%，報4.70美元。
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譯文內容由第三人軟體翻譯。
