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Over 6.7 million Americans aged 65 and older are living with Alzheimer’s disease (AD) and this number is predicted to grow to 13.8 million by 2060. AD is the sixth leading cause of death in the
Currently, there is no perfect treatment for AD or ADD. Otsuka’s (OTC: OSUKF) Rexulti is one of the major medications currently being explored as a potential treatment for Alzheimer's disease. It was originally developed as an atypical antipsychotic to help treat mental health illnesses, and it is believed to work by affecting the activity of certain neurotransmitters in the brain. Due to this, ongoing research is investigating its potential to address the behavioral and psychological symptoms often associated with the condition, such as agitation and aggression, but some concerns are yet to be addressed.
One of the major criticisms of Rexulti is that it carries a black box warning regarding the increased risk of death in elderly patients with dementia-related psychosis. Patients have reported adverse events associated with the drug like restlessness, weight gain and sleepiness. IGC Pharma (AMEX: IGC) is looking to an alternative to existing drugs with its drug, IGC-AD1, which has been specifically designed to target the underlying causes of AAD and aims to fill the gap for a safe and effective therapy.
IGC Pharma began developing IGC-AD1 in 2017, and it was approved by the FDA as an investigational new drug in 2019. IGC-AD1 is designed to target neuroinflammation and dysfunction of the CB1 receptor. This investigational drug contains THC as one of two active pharmaceutical agents. THC is the primary psychoactive compound found in the cannabis plant.
IGC-AD1 is undergoing extensive clinical trials to evaluate its effectiveness and safety in treating Alzheimer's disease. After a successful phase 1 clinical trial that resulted in patent protection in the
The company has just announced the results of an interim analysis of its ongoing phase 2 trial. The main objective of the study is to evaluate the change in AAD over six weeks, utilizing the Cohen Mansfield Agitation Inventory (CMAI). According to IGC Pharma, the study showed that patients who were given IGC-AD1 had a more significant reduction in agitation levels compared to those who were given a placebo, with positive effects being observed as early as week two of the trial.
At the six-week mark, the difference in agitation levels between the IGC-AD1 group and the placebo group was quite noticeable, with an effect size of 0.66 according to Cohen's d measure. The mean difference in the CMAI scores between the active treatment and placebo was -10.45, which indicates a meaningful contrast. Additionally, at the two-week mark, a secondary evaluation showed a positive effect size of 0.79 for IGC-AD1 compared to the placebo.
If IGC-AD1 continues to perform well in clinical trials, it could be an effective, simpler and faster treatment option for patients – and importantly, the company is aiming to deliver a product with full approval from the FDA without major black box warnings. The formula as an oral liquid solution also caters to the older population. For millions of Americans who have family members with AD or are worried about developing AD later in life, this drug could provide hope.
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These forward-looking statements are based largely on IGC Pharma’s expectations and are subject to several risks and uncertainties, certain of which are beyond IGC Pharma’s control. Actual results could differ materially from these forward-looking statements as a result of, among other factors, the Company’s failure or inability to commercialize one or more of the Company’s products or technologies, including the products or formulations described in this release, or failure to obtain regulatory approval for the products or formulations, where required, or government regulations affecting AI or the AI algorithms not working as intended or producing accurate predictions; general economic conditions that are less favorable than expected; the FDA’s general position regarding cannabis- and hemp-based products; and other factors, many of which are discussed in IGC Pharma’s
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