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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.
The data demonstrates a clinically significant reduction, approaching statistical significance, in agitation in Alzheimer's at week two compared to placebo.
IGC-AD1 targets neuroinflammation and CB1 receptor dysfunction, and the investigational drug contains THC as one of two active pharmaceutical agents.
"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.
"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.
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.
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.
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.
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.
Over 1,000 oral doses have been administered to date, with no dose-limiting adverse events observed.
Price Action: IGC shares are up 19.50% at $0.52 on the last check Tuesday.
Image: Wally Crawfish from Pixabay
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.
周二,IGC Pharma Inc(纽约证券交易所代码:IGC)发布了其针对与阿尔茨海默氏症相关的痴呆激动的 IGC-AD1 二期临床试验的中期数据。
The data demonstrates a clinically significant reduction, approaching statistical significance, in agitation in Alzheimer's at week two compared to placebo.
数据表明,与安慰剂相比,第二周阿尔茨海默氏症的激动情绪在临床上显著降低,接近统计学意义。
IGC-AD1 targets neuroinflammation and CB1 receptor dysfunction, and the investigational drug contains THC as one of two active pharmaceutical agents.
IGC-AD1 靶向神经炎症和 CB1 受体功能障碍,该研究药物含有四氢大麻酚作为两种活性药物之一。
"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首席执行官拉姆·穆昆达表示:“我们很高兴与大家分享,次要结果的中期结果表明,与安慰剂相比,IGC-AD1 可以快速缓解阿尔茨海默氏痴呆症的焦虑,几乎没有副作用。”
"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.
穆昆达补充说:“美国约有650万人患有阿尔茨海默氏症,其中大多数人患有一种称为阿尔茨海默氏痴呆激动的医学综合症... 中期数据表明,IGC-AD1 具有潜在临床益处的早期迹象,但极少出现限制性治疗的副作用。”
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.
次要结果是使用标准测量量表用激动与安慰剂的变化来衡量,即基线和第二周的科恩·曼斯菲尔德激动清单(CMAI)的效应大小(ES)为0.79(p=0.071),表明活性组和安慰剂组之间的差异很大。
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 年发表的一项研究得出结论,效应大小超过 0.5 对细心观察者来说意味着明显的变化,这突显了 IGC-AD1 的显著影响。
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,美国食品药品管理局批准了大冢控股有限公司(场外交易代码:OTSKY)(场外交易代码:OTSKF)Rexulti(brexpiprazole),一种非典型抗精神病药物,并附有方框警告。该批准是在一项规模明显扩大的为期12周的3期试验之后获得的,该试验显示科恩的d效应大小为0.35,而 IGC-AD1 在两周内显示的效应大小为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.
正在进行的 146 名患者临床试验是一项多中心、双盲、随机、安慰剂对照的研究,旨在评估 IGC-AD1 治疗阿尔茨海默氏症所致痴呆激动的安全性和有效性。
Over 1,000 oral doses have been administered to date, with no dose-limiting adverse events observed.
迄今为止,已服用超过1,000剂口服,未观察到剂量限制性不良事件。
Price Action: IGC shares are up 19.50% at $0.52 on the last check Tuesday.
价格走势:在周二的最后一次支票中,IGC股价上涨19.50%,至0.52美元。
Image: Wally Crawfish from Pixabay
图片:来自 Pixabay 的 Wally Crawfish
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moomoo是Moomoo Technologies Inc.公司提供的金融信息和交易应用程序。
在美国,moomoo上的投资产品和服务由Moomoo Financial Inc.提供,一家受美国证券交易委员会(SEC)监管的持牌主体。 Moomoo Financial Inc.是金融业监管局(FINRA)和证券投资者保护公司(SIPC)的成员。
在新加坡,moomoo上的投资产品和服务是通过Moomoo Financial Singapore Pte. Ltd.提供,该公司受新加坡金融管理局(MAS)监管(牌照号码︰CMS101000) ,持有资本市场服务牌照 (CMS) ,持有财务顾问豁免(Exempt Financial Adviser)资质。本内容未经新加坡金融管理局的审查。
在澳大利亚,moomoo上的金融产品和服务是通过Futu Securities (Australia) Ltd提供,该公司是受澳大利亚证券和投资委员会(ASIC)监管的澳大利亚金融服务许可机构(AFSL No. 224663)。请阅读并理解我们的《金融服务指南》、《条款与条件》、《隐私政策》和其他披露文件,这些文件可在我们的网站 https://www.moomoo.com/au中获取。
在加拿大,通过moomoo应用提供的仅限订单执行的券商服务由Moomoo Financial Canada Inc.提供,并受加拿大投资监管机构(CIRO)监管。
在马来西亚,moomoo上的投资产品和服务是通过Moomoo Securities Malaysia Sdn. Bhd. 提供,该公司受马来西亚证券监督委员会(SC)监管(牌照号码︰eCMSL/A0397/2024) ,持有资本市场服务牌照 (CMSL) 。本内容未经马来西亚证券监督委员会的审查。
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