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Annovis Bio CEO Outlines Next Steps in Alzheimer's Research After Mixed Phase II/III Trial Results

Annovis Bio CEO Outlines Next Steps in Alzheimer's Research After Mixed Phase II/III Trial Results

Annovis Bio首席執行官在II/III期試驗結果好壞參半之後概述了阿爾茨海默氏症研究的下一步行動
Benzinga ·  05/06 19:35

Annovis Bio, Inc. (NYSE:ANVS) ("Annovis" or the "Company"), a clinical-stage drug platform company developing novel therapies for neurodegenerative diseases, announced that Maria Maccecchini, Founder, President, and CEO of Annovis, issued a letter to stockholders providing a review of Phase II/III data from its Alzheimer's study and sharing next steps.

開發神經退行性疾病新療法的臨床階段藥物平台公司Annovis Bio, Inc.(紐約證券交易所代碼:ANVS)(“Annovis” 或 “公司”)宣佈,Annovis創始人、總裁兼首席執行官Maria Maccecchini致函股東,對阿爾茨海默氏症研究的II/III期數據進行了審查,並分享了後續步驟。

Dear Friends,

親愛的朋友們,

The last few days have been very difficult. I received a lot of emails and phone calls that often expressed anger, uncertainty, and disappointment. Additionally, our results were questioned and criticized. This reaction not only caused a drastic drop in our share price, but, more importantly, it saddened the Annovis team. We are determined to develop a drug that treats Alzheimer's (AD) and Parkinson's diseases (PD) and makes the life of the afflicted people and their caretakers easier. However, every setback makes it harder to reach this goal.

過去的幾天非常艱難。我收到了很多電子郵件和電話,這些電子郵件和電話經常表達憤怒、不確定性和失望。此外,我們的結果受到了質疑和批評。這種反應不僅導致我們的股價急劇下跌,更重要的是,它使Annovis團隊感到難過。我們決心開發一種治療阿爾茨海默氏症(AD)和帕金森氏病(PD)的藥物,使患者及其看護人的生活更輕鬆。但是,每一次挫折都使實現這一目標變得更加困難。

At Annovis, we hold rigorous science, open communication, and transparency seriously, and it is our responsibility to conduct a clinical study in conformance with FDA guidelines and to the highest standards possible. In science, results are often less than perfect, but they pave the way for a better plan when designing and executing the next steps.

在Annovis,我們認真對待嚴謹的科學、開放的溝通和透明度,我們有責任根據美國食品藥品管理局的指導方針和儘可能高的標準進行臨床研究。在科學領域,結果往往不夠完美,但它們爲設計和執行後續步驟時更好的計劃鋪平了道路。

The Phase II/III study provided us with valuable information for an improved Phase III pivotal trial. First, we will prescreen patients for plasma AD biomarkers to confirm the diagnosis. Second, we will only enroll patients with early and mild Alzheimer's (MMSE 21-28), the subpopulation which showed the highest level of improvement after buntanetap, as seen from our completed AD studies (Table 1).

II/III期研究爲我們改進的III期關鍵試驗提供了寶貴的信息。首先,我們將對患者進行血漿 AD 生物標誌物預篩查,以確認診斷。其次,我們將只招收早期和輕度阿爾茨海默氏症(MMSE 21-28)患者,從我們已完成的AD研究(表1)中可以看出,該亞群在buntanetap之後改善程度最高。

Study AD patient # Patients Endpoint Duration Drug vs
Baseline
Drug vs
Placebo
Phase IIa; 2021 MMSE 18-28 14 ADAS-Cog11 1 month -4.4 -3.2
Phase II/III; 2024 MMSE 21-24 90 ADAS-Cog11 3 months -3.3 -2.36
Phase II/III; 2024 MMSE 14-20 112 ADAS-Cog11 3 months -0.65 1.79
學習 AD 患者 # 患者 端點 持續時間 毒品 vs
基線
毒品 vs
安慰劑
第二階段;2021 MMSE 18-28 14 ADAS-COG11 1 個月 -4.4 -3.2
第二/三階段;2024 MMSE 21-24 90 ADAS-COG11 3 個月 -3.3 -2.36
第二/三階段;2024 MMSE 14-20 112 ADAS-COG11 3 個月 -0.65 1.79

Table 1. Summary of cognitive response to buntanetap at different disease stages measured in completed AD studies conducted by Annovis. The table clearly shows a strong response in patients with early AD (MMSE 18-28 and MMSE 21-24), while in moderate AD patients (MMSE 14-20), the response is obscured by high placebo effect.

表 1。Annovis進行的已完成的AD研究中測量的不同疾病階段對buntanetap的認知反應摘要。該表清楚地顯示了早期AD(MMSE 18-28和MMSE 21-24)患者的強烈反應,而在中度AD患者(MMSE 14-20)中,高安慰劑效應掩蓋了反應。

The goal of the Phase II/III trial was to learn about the breadth of our drug's efficacy and to obtain information for a pivotal disease-modifying study. This goal was achieved. We believe that the FDA will accept buntanetap for symptomatic relief and will allow us to continue with the next pivotal Phase III study for disease-modification.

II/III期試驗的目標是了解我們藥物療效的廣度,併爲一項關鍵的疾病改善研究獲取信息。這個目標已經實現。我們相信,美國食品藥品管理局將接受buntanetap來緩解症狀,並將允許我們繼續進行下一個關鍵的III期疾病治療研究。

譯文內容由第三人軟體翻譯。


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