POTOMAC, Md. - IGC Pharma Inc. (NYSE American: IGC) has shared interim results from its Phase 2 clinical trial of IGC-AD1, which is being investigated as a treatment for agitation in patients with Alzheimer’s disease. The data indicates a statistically significant reduction in agitation levels compared to a placebo.
The trial, which is still enrolling participants, aims to measure the change in agitation using the Cohen Mansfield Agitation Inventory (CMAI) over six weeks. Interim results show that patients administered IGC-AD1 experienced a more considerable reduction in their agitation scores than those given a placebo, with the difference becoming noticeable from the second week of treatment.
At week six, the primary outcome showed a Cohen’s d effect size of 0.66, which indicates the superiority of IGC-AD1 over placebo. The Least Square (LS) mean difference between the active and placebo groups was -10.45, with a p-value of 0.037 for the combined results of weeks two and six. A pre-specified secondary endpoint at week two revealed an effect size of 0.79.
The interim analysis suggests that IGC-AD1 could potentially meet a significant unmet medical need in Alzheimer’s disease management. Ram Mukunda, CEO 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 exhibit agitation.
In comparison to Brexpiprazole, an atypical antipsychotic approved by the FDA in May 2023 for the same indication, IGC-AD1’s interim results appear favorable. Brexpiprazole showed a lower LS mean difference from baseline CMAI and a smaller Cohen’s d effect size in its Phase 3 trial.
IGC-AD1 is designed to target the underlying causes of agitation in Alzheimer’s disease, including neuroinflammation and CB1 receptor dysfunctions. The ongoing trial in the U.S. and Canada has enrolled 146 patients, with these interim results based on a subset of 26 participants. The company notes that the positive interim findings may not necessarily predict the final trial 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 statement.
InvestingPro Insights
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 InvestingPro data, IGC Pharma has a market capitalization of 23.6 million USD, indicating a relatively small player in the pharmaceutical industry. Despite this, the company has experienced significant stock price movements, with a remarkable 29.61% return over the last month and a 35.02% year-to-date price total return, reflecting investor optimism following the recent trial updates.
InvestingPro Tips highlight that IGC Pharma is quickly burning through cash, which is a critical consideration for investors, especially given that analysts do not anticipate the company will be profitable this year. The company's volatility is also notable, with stock price movements being quite erratic. This could be attributed to the speculative nature of investing in a company with a drug in clinical trials, where outcomes can significantly impact the stock's value.
While IGC Pharma does not pay a dividend, suggesting a reinvestment of earnings into research and development, it is essential to note that the company is not profitable over the last twelve months. This information, coupled with a high revenue valuation multiple, could signal caution for potential investors. On the other hand, the strong return over the last three months may attract those looking for short-term gains based on recent positive news.
For more detailed analysis and additional InvestingPro Tips, 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 with the use of coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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