Alzheimer's-Focused Small Cap Firm IGC Pharma Releases Data, Candidate Reduces Agitation Compared To Placebo
Alzheimer's-Focused Small Cap Firm IGC Pharma Releases Data, Candidate Reduces Agitation Compared To Placebo
Wednesday, IGC Pharma Inc (NYSE:IGC) announced the results of an interim analysis of its ongoing Phase 2 trial of IGC-AD1 for Agitation in Dementia from Alzheimer's Disease (AAD).
周三，IGC Pharma Inc（纽约证券交易所代码：IGC）公布了其正在进行的针对阿尔茨海默氏病（AAD）痴呆激动的 IGC-AD1 二期试验的中期分析结果。
The interim data demonstrates a clinical and statistically significant reduction in agitation compared to placebo in patients with Alzheimer's disease.
中期数据表明，与安慰剂相比，阿尔茨海默氏病患者的激动情绪在临床和统计学上均显著降低。
The study's primary goal is to assess the change in AAD after six weeks using a standard scale, the Cohen Mansfield Agitation Inventory (CMAI).
该研究的主要目标是使用标准量表，即科恩·曼斯菲尔德激动清单（CMAI）评估六周后AAD的变化。
Based on interim data, patients taking IGC-AD1, on average, experienced a more significant reduction in agitation scores compared to those on placebo, and the positive effects were observed as early as week two of the trial.
根据中期数据，与服用安慰剂的患者相比，服用 IGC-AD1 的患者的激动评分平均下降幅度更大，而且早在试验的第二周就观察到了积极的效果。
At the primary outcome, assessing the change in agitation as measured by the CMAI at week 6, the Cohen's d effect size indicating the superiority of IGC-ADI over placebo was 0.66.
主要结局是评估CMAI在第6周测得的激动变化，表明IGC-ADI优于安慰剂的Cohen's d效应大小为0.66。
The CMAI Least Square (LS) mean difference between active and placebo was -10.45, with a p-value of 0.037 (for combined week two and week six results).
活性药物和安慰剂之间的CMAI最小平方（LS）平均差值为-10.45，p值为0.037（第二周和第六周的合并结果）。
In addition, at the pre-specified secondary endpoint, change at week two, the effect size was 0.79.
此外，在预先指定的次要终点，即第二周的变化，效应大小为0.79。
Cohen's d is a standardized statistical effect size that describes the magnitude of the difference between two groups, considering the variability in outcomes.
Cohen's d 是一个标准化的统计效应大小，它描述了两组之间差异的大小，同时考虑了结果的可变性。
In May 2023, the FDA approved Otsuka Holding Co Ltd's (OTC:OTSKY) (OTC:OTSKF) Rexulti (brexpiprazole), an atypical antipsychotic, with a boxed warning.
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。
The approval followed a significantly larger 12-week Phase 3 trial, which showed a difference in LS mean from baseline CMAI between active and placebo of -5.32, a Cohen's d effect size of 0.35, and a p-value of 0.003.
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，该试验显示活性药物和安慰剂之间的LS平均值与基线CMAI的差异为-5.32，科恩的d效应大小为0.35，p值为0.003。
In 2023, the number of Americans living with Alzheimer's was estimated at 6.7 million. According to one estimate, as many as 76% of them suffer from AAD.
2023年，患有阿尔茨海默氏症的美国人人数估计为670万。根据一项估计，多达76％的人患有AAD。
The 146-patient IGC-AD1 trial, for which these interim results are presented, continues to enroll in the U.S. and Canada.
已公布这些中期结果的146名患者的 IGC-AD1 试验继续在美国和加拿大注册。
"With IGC-AD1's promising clinical profile, we are confident in its ability, subject to further trials, to improve patient outcomes and drive shareholder value," said Ram Mukunda, CEO of IGC Pharma.
IGC Pharma首席执行官拉姆·穆昆达表示：“由于 IGC-AD1 的临床表现令人鼓舞，我们对它改善患者预后和提高股东价值的能力充满信心，但尚待进一步试验。”
Price Action: IGC shares are down 13.80% at $0.33 on the last check Wednesday.
价格走势：在周三的最后一次支票中，IGC股价下跌13.80％，至0.33美元。
Photo by Gerd Altmann via Pixabay
照片由 Gerd Altmann 通过 Pixabay 拍摄