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).
週三，IGC Pharma Inc（紐約證券交易所代碼：IGC）公佈了其正在進行的針對阿爾茨海默氏病（AAD）癡呆激動的 IGC-AD1 二期試驗的中期分析結果。
The interim data demonstrates a clinical and statistically significant reduction in agitation compared to placebo in patients with Alzheimer's disease.
中期數據表明，與安慰劑相比，阿爾茨海默氏病患者的激動情緒在臨床和統計學上均顯著降低。
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).
該研究的主要目標是使用標準量表，即科恩·曼斯菲爾德激動清單（CMAI）評估六週後AAD的變化。
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.
根據中期數據，與服用安慰劑的患者相比，服用 IGC-AD1 的患者的激動評分平均下降幅度更大，而且早在試驗的第二週就觀察到了積極的效果。
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.
主要結局是評估CMAI在第6周測得的激動變化，表明IGC-ADI優於安慰劑的Cohen's d效應大小爲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).
活性藥物和安慰劑之間的CMAI最小平方（LS）平均差值爲-10.45，p值爲0.037（第二週和第六週的合併結果）。
In addition, at the pre-specified secondary endpoint, change at week two, the effect size was 0.79.
此外，在預先指定的次要終點，即第二週的變化，效應大小爲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 是一個標準化的統計效應大小，它描述了兩組之間差異的大小，同時考慮了結果的可變性。
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。
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.
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，該試驗顯示活性藥物和安慰劑之間的LS平均值與基線CMAI的差異爲-5.32，科恩的d效應大小爲0.35，p值爲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，患有阿爾茨海默氏症的美國人人數估計爲670萬。根據一項估計，多達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.
已公佈這些中期結果的146名患者的 IGC-AD1 試驗繼續在美國和加拿大註冊。
"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首席執行官拉姆·穆昆達表示：“由於 IGC-AD1 的臨床表現令人鼓舞，我們對它改善患者預後和提高股東價值的能力充滿信心，但尚待進一步試驗。”
Price Action: IGC shares are down 13.80% at $0.33 on the last check Wednesday.
價格走勢：在週三的最後一次支票中，IGC股價下跌13.80％，至0.33美元。
Photo by Gerd Altmann via Pixabay
照片由 Gerd Altmann 通過 Pixabay 拍攝