IGC Pharma Says Cannabinoid-Based Drug Candidate Provides Fast Relief With Fewer Side Effects For Alzheimer's-Associated Agitation
IGC Pharma Says Cannabinoid-Based Drug Candidate Provides Fast Relief With Fewer Side Effects For Alzheimer's-Associated Agitation
Tuesday, IGC Pharma Inc (NYSE:IGC) released interim data from its Phase 2 clinical trial of IGC-AD1 for agitation in dementia associated with Alzheimer's.
週二，IGC Pharma Inc（紐約證券交易所代碼：IGC）發佈了其針對與阿爾茨海默氏症相關的癡呆激動的 IGC-AD1 二期臨床試驗的中期數據。
The data demonstrates a clinically significant reduction, approaching statistical significance, in agitation in Alzheimer's at week two compared to placebo.
數據表明，與安慰劑相比，第二週阿爾茨海默氏症的激動情緒在臨床上顯著降低，接近統計學意義。
IGC-AD1 targets neuroinflammation and CB1 receptor dysfunction, and the investigational drug contains THC as one of two active pharmaceutical agents.
IGC-AD1 靶向神經炎症和 CB1 受體功能障礙，該研究藥物含有四氫大麻酚作爲兩種活性藥物之一。
"We are excited to share that the interim results on the secondary outcome show that IGC-AD1 can provide fast relief with few side effects in reducing agitation in Alzheimer's dementia compared to placebo," said Ram Mukunda, CEO of IGC Pharma.
IGC Pharma首席執行官拉姆·穆昆達表示：“我們很高興與大家分享，次要結果的中期結果表明，與安慰劑相比，IGC-AD1 可以快速緩解阿爾茨海默氏癡呆症的焦慮，幾乎沒有副作用。”
"Approximately 6.5 million individuals in the U.S. live with Alzheimer's and a majority experience a medical syndrome called agitation in Alzheimer's dementia...The interim data indicate early signs of potential clinical benefit with IGC-AD1 with infrequent treatment-limiting side effects," added Mukunda.
穆昆達補充說：“美國約有650萬人患有阿爾茨海默氏症，其中大多數人患有一種稱爲阿爾茨海默氏癡呆激動的醫學綜合症... 中期數據表明，IGC-AD1 具有潛在臨床益處的早期跡象，但極少出現限制性治療的副作用。”
The secondary outcome, as measured by the change in agitation versus placebo using a standard measurement scale, the Cohen Mansfield Agitation Inventory (CMAI) at baseline and week 2, exhibited an Effect Size (ES) of 0.79 (p=0.071), indicating a large magnitude of difference between the active and placebo groups.
次要結果是使用標準測量量表用激動與安慰劑的變化來衡量，即基線和第二週的科恩·曼斯菲爾德激動清單（CMAI）的效應大小（ES）爲0.79（p=0.071），表明活性組和安慰劑組之間的差異很大。
For context, a study published in 2003 concluded that an effect size over 0.5 corresponds to a noticeable change to a careful observer, highlighting the notable impact of IGC-AD1.
就背景而言，2003 年發表的一項研究得出結論，效應大小超過 0.5 對細心觀察者來說意味着明顯的變化，這突顯了 IGC-AD1 的顯著影響。
In May 2023, the FDA approved Otsuka Holding Co Ltd's (OTC:OTSKY) (OTC:OTSKF) Rexulti (brexpiprazole), an atypical antipsychotic, with a boxed warning. This approval followed a significantly larger 12-week Phase 3 trial, which showed a Cohen's d effect size of 0.35, whereas IGC-AD1 showed an effect size of 0.79 in two weeks.
2023年5月，美國食品藥品管理局批准了大冢控股有限公司（場外交易代碼：OTSKY）（場外交易代碼：OTSKF）Rexulti（brexpiprazole），一種非典型抗精神病藥物，並附有方框警告。該批准是在一項規模明顯擴大的爲期12周的3期試驗之後獲得的，該試驗顯示科恩的d效應大小爲0.35，而 IGC-AD1 在兩週內顯示的效應大小爲0.79。
The ongoing 146-patient clinical trial is a multicenter, double-blind, randomized, placebo-controlled study designed to assess the safety and efficacy of IGC-AD1 in treating agitation in dementia due to Alzheimer's.
正在進行的 146 名患者臨床試驗是一項多中心、雙盲、隨機、安慰劑對照的研究，旨在評估 IGC-AD1 治療阿爾茨海默氏症所致癡呆激動的安全性和有效性。
Over 1,000 oral doses have been administered to date, with no dose-limiting adverse events observed.
迄今爲止，已服用超過1,000劑口服，未觀察到劑量限制性不良事件。
Price Action: IGC shares are up 19.50% at $0.52 on the last check Tuesday.
價格走勢：在週二的最後一次支票中，IGC股價上漲19.50％，至0.52美元。
Image: Wally Crawfish from Pixabay
圖片：來自 Pixabay 的 Wally Crawfish
譯文內容由第三人軟體翻譯。