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POTOMAC, Md. – IGC Pharma Inc. (NYSE American: IGC) shared interim results from its Phase 2 clinical trial of IGC-AD1, which is being studied as a treatment for agitation in patients with Alzheimer’s disease. The data indicate a statistically significant reduction in agitation levels compared to placebo.
The study, which is still enrolling participants, aims to measure change in agitation using the Cohen Mansfield Agitation Inventory (CMAI) over six weeks. The interim results show that patients given IGC-AD1 experienced a more notable reduction in agitation scores than those given a placebo, with the difference becoming apparent starting in the second week of treatment.
At week 6, the primary outcome showed a Cohen d effect size of 0.66, indicating superiority of IGC-AD1 over placebo. The least squares (LS) mean difference between the active and placebo groups was -10.45, with a p-value of 0.037 for the combined results from weeks two and six. A pre-specified secondary endpoint at week 2 revealed an effect size of 0.79.
Interim analysis suggests that IGC-AD1 could potentially address a significant unmet medical need in the management of Alzheimer’s disease. Ram Mukunda, chief executive officer of IGC Pharma, expressed optimism about the results, indicating the company’s commitment to advancing the drug towards commercialization. He highlighted the potential benefits for caregivers and families, given the emotional toll associated with managing Alzheimer’s patients, particularly those who display agitation.
Compared to Brexpiprazole, an atypical antipsychotic approved by the FDA in May 2023 for the same indication, the interim results of IGC-AD1 appear favorable. Brexpiprazole showed a smaller LS mean difference from baseline CMAI and a smaller Cohen d effect size in its Phase 3 study.
IGC-AD1 is designed to target the underlying causes of agitation in Alzheimer’s disease, including neuroinflammation and CB1 receptor dysfunction. The ongoing study in the United States and Canada has enrolled 146 patients, with these interim results based on a subgroup of 26 participants. The company notes that positive interim results may not necessarily predict final study outcomes.
IGC Pharma is developing a pipeline of drug candidates for Alzheimer’s disease and is also exploring the use of artificial intelligence in Alzheimer’s research.
This article is based on a press release.
Insights on InvestingPro
As IGC Pharma Inc. (NYSE American: IGC) reveals promising interim results from its Phase 2 clinical trial, investors are closely monitoring the company’s financial health and stock performance. According to data from InvestingPro, IGC Pharma has a market capitalization of $23.6 million, indicating a relatively small player in the pharmaceutical sector. Despite this, the company has seen significant share price movements, with a notable return of 29.61% over the past month and a year-to-date total price return of 35.02%, reflecting investor optimism following to recent test updates.
InvestingPro tips highlight that IGC Pharma is rapidly burning through cash, which is a key consideration for investors, especially given that analysts don’t expect the company to be profitable this year. The company’s volatility is also notable, with share price movements being quite erratic. This could be attributed to the speculative nature of investing in a company with a drug in clinical trials, the results of which can have a significant impact on the value of the stock.
While IGC Pharma does not pay a dividend, suggesting a reinvestment of profits into research and development, it is essential to note that the company did not make a profit in the last twelve months. This information, along with a high revenue valuation multiple, could signal caution for potential investors. On the other hand, the strong performance over the past three months may appeal to those seeking short-term gains based on recent positive news.
For more detailed analysis and additional insights into InvestingPro, including the company’s moderate level of debt and its implications, investors can explore the dedicated section on InvestingPro. There are currently 9 more tips available for IGC Pharma, which can be accessed using the coupon code PRONEWS24 to get an additional 10% discount on the annual or biennial Pro and Pro+ subscription.
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