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Why Is Alzheimer's-Focused Annovis Bio Stock Nosediving On Monday?

Why Is Alzheimer's-Focused Annovis Bio Stock Nosediving On Monday?

爲什麼以阿爾茨海默氏症爲重點的Annovis Bio股票在週一暴跌?
Benzinga ·  04/30 01:53

Annovis Bio Inc (NASDAQ:ANVS) shares plunged after the company released data from its Phase 2/3 Alzheimer study of buntanetap in mild to moderate Alzheimer's patients.

Annovis Bio Inc(納斯達克股票代碼:ANVS)公佈了針對輕度至中度阿爾茨海默氏症患者的buntanetap的2/3期阿爾茨海默氏症研究的數據,股價暴跌。

Investors are reacting as during the trial, ADCS-CGIC in all groups of patients barely changed, with no statistically significant difference observed.

投資者的反應是,在試驗期間,所有患者組的ADCS-CGIC幾乎沒有變化,沒有觀察到統計學上的顯著差異。

The 15mg and 30mg buntanetap groups slightly improved in mild Alzheimer's patients.

輕度阿爾茨海默氏症患者的15mg和30mg buntanetap組略有改善。

The ADCS-CGIC is a clinician-rated measure of global severity at baseline scored from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).

ADCS-CGIC是臨床醫生評定的全球嚴重程度的衡量標準,基線評分範圍爲1(正常,完全沒有病)至7(病情最嚴重的患者)。

The company also observed a large placebo effect in ADCS-ADL, with 15mg and 30mg buntanetap groups showing similar improvements with no statistical difference between the groups.

該公司還觀察到ADCS-ADL具有很大的安慰劑效應,15mg和30mg buntanetap組顯示出類似的改善,兩組之間沒有統計學差異。

The ADCS-ADL is an informant-rated measure of functional impairment scored from 0 to 78, where a higher score indicates less impairment.

ADCS-ADL是一項由線人評定的功能障礙評分標準,評分從0到78不等,其中分數越高表示損傷越少。

Annovis Bio observed improvement in ADAS-Cog 11 scores in each treatment dose relative to placebo.

Annovis Bio觀察到,與安慰劑相比,每種治療劑量的ADAS-Cog 11分數都有所改善。

ADAS-Cog is an objective measure of cognitive impairment, scored from 0 to 70, with a higher score indicating more impairment.

ADAS-Cog 是認知障礙的客觀衡量標準,評分從 0 到 70,分數越高表示損傷越多。

The analysis focused on biomarker-positive early AD patients (MMSE 21-24, pTau217/tTau≥4.2%) and found that ADAS-Cog 11 was highly statistically significant at all three dose levels and in the combined dose levels compared to placebo as well as to baseline.

該分析側重於生物標誌物陽性的早期 AD 患者(MMSE 21-24,ptau217/TTAU≥ 4.2%),發現與安慰劑和基線相比,ADAS-Cog 11在所有三種劑量水平和組合劑量水平上均具有很高的統計學意義。

At the end of 3 months of treatment, the placebo group demonstrated slight improvement but was not significantly different from the baseline.

在3個月的治療結束時,安慰劑組表現出輕微改善,但與基線沒有顯著差異。

All three buntanetap treatment groups showed statistically significant improvement from their corresponding baseline (7.5mg improved 2.19 (0.87), p=0.013; 15mg improved 2.79 (0.81), p=0.001; 30mg improved 3.32 (0.82), P<0.001).

所有三個buntanetap治療組均比相應的基線顯示出統計學上的顯著改善(7.5mg改善了2.19(0.87),p = 0.013;15mg改善了2.79(0.81),p = 0.001;30mg改善了3.32(0.82),P

The 15mg and 30mg treatment groups also showed statistically significant improvement relative to the placebo group (p=0.042 and 0.015, respectively).

與安慰劑組相比,15mg和30mg治療組也顯示出統計學上的顯著改善(分別爲p=0.042和0.015)。

Buntanetap was very well tolerated. The safety profile observed in this study was consistent with prior clinical trials.

Buntanetap 的耐受性非常好。本研究中觀察到的安全性與先前的臨床試驗一致。

The company says the short study shows a symptomatic effect with a possible disease-modification trend according to the tau data. The next study will have a longer duration, improved design and be statistically powered to validate symptomatic improvement and disease-modification.

該公司表示,根據tau的數據,這項短期研究顯示出症狀效應,並可能出現疾病改善趨勢。下一項研究將持續更長的時間,改進的設計,並具有統計依據,可以驗證症狀改善和疾病的改變。

The company plans to measure additional biomarkers for inflammation and axonal and synaptic functions.

該公司計劃測量其他生物標誌物的炎症以及軸突和突觸功能。

Annovis Bio expects to discuss the data with the FDA in the next two to three months and then move on to the next Phase 3 study to confirm and expand these findings in an 18-month disease-modifying trial focusing on biomarker-positive early patients.

Annovis Bio預計將在未來兩到三個月內與美國食品藥品管理局討論這些數據,然後進入下一項3期研究,在一項爲期18個月的疾病改善試驗中確認和擴展這些發現,該試驗的重點是生物標誌物陽性的早期患者。

Price Action: ANVS shares are down 50.6% at $8.90 at the last check Monday.

價格走勢:週一最後一次檢查時,ANVS股價下跌50.6%,至8.90美元。

Photo via Shutterstock

照片來自 Shutterstock

譯文內容由第三人軟體翻譯。


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