IGC Pharma Activates ClinCloud, One of 12 Sites in Ongoing Phase 2b Alzheimer’s Trial

Rhea-AI Summary

IGC Pharma, Inc. (NYSE American: IGC) announced that ClinCloud has dosed its first patient in a Phase 2b trial investigating the safety and efficacy of IGC-AD1 on agitation in Alzheimer’s Disease. The trial aims to develop an innovative therapy for addressing the significant distress caused by agitation in Alzheimer's patients. The expansion of the trial network underscores the commitment to a robust, scientifically driven approach, with 12 sites in the US and Canada. The trial will enroll 146 patients, with one half receiving IGC-AD1 and the other half receiving a placebo.

Positive

• Strategic expansion of trial network to strengthen data collection and increase population diversity
• Partnership with ClinCloud to support the pursuit of an innovative therapy for agitation in Alzheimer's disease
• Progress in patient and trial site recruitment, with optimism for developing an effective and safe therapy

Negative

• None.

Insights

Medical Research Analyst

The initiation of patient dosing in a Phase 2b trial by IGC Pharma for IGC-AD1 is a critical milestone in the drug's development pathway. The focus on agitation in Alzheimer's—a symptom affecting a significant proportion of patients—addresses a substantial unmet medical need. The compound's mechanism, targeting CB1 receptors and inflammasomes, is grounded in the pathophysiology of Alzheimer's, where neuroinflammation and neurotransmitter imbalance play crucial roles.

From a research perspective, the expansion of the trial to multiple sites, including ClinCloud's facilities, enhances the potential for a diverse patient population, which is vital for the generalizability of the trial results. The inclusion of 146 patients provides a robust sample size for detecting treatment effects. However, it's essential to consider that the efficacy and safety profile of IGC-AD1 will need to be thoroughly evaluated against existing treatments, if any and placebo effects. The long-term implications for stakeholders include the potential for a new therapeutic option that could improve patient quality of life and reduce caregiver burden.

Market Research Analyst

In terms of market potential, Alzheimer's disease represents a growing therapeutic area due to the aging global population. A successful trial outcome for IGC-AD1 could position IGC Pharma in a lucrative market segment. The demand for treatments targeting neuropsychiatric symptoms associated with Alzheimer's, such as agitation, is expected to rise. This trial could be a key differentiator for IGC Pharma, potentially attracting investor interest and partnerships.

It is important to monitor the trial's progress closely, as positive results could lead to an increase in the company's stock value. Conversely, any setbacks could have a negative impact. Investors will likely assess the risk-reward profile based on the trial's success probability and the competitive landscape of Alzheimer's treatments. The strategic expansion of the trial network is an indicator of IGC Pharma's commitment to developing a comprehensive data set, which can be a positive signal to the market.

Healthcare Economist

The economic implications of an effective treatment for agitation in Alzheimer's are significant. Alzheimer's disease imposes a substantial economic burden on healthcare systems worldwide, with costs associated with long-term care and hospitalization. A treatment like IGC-AD1 could potentially reduce these costs by mitigating one of the most challenging symptoms of the disease.

Moreover, the societal impact, including the potential reduction in caregiver stress and the improvement in the quality of life for patients, can translate into economic benefits such as increased productivity and decreased absenteeism for caregivers. The trial's focus on underrepresented populations could also address health disparities, leading to more equitable healthcare outcomes. The success of IGC-AD1 could encourage further investment in Alzheimer's research, potentially leading to a ripple effect of innovation in the sector.

- ClinCloud has dosed its first patient in trial investigating the safety and efficacy of IGC-AD1 on agitation in Alzheimer’s Disease -

POTOMAC, Md.--(BUSINESS WIRE)-- IGC Pharma, Inc. (NYSE American: IGC) (“IGC” or the “Company”), today announced that ClinCloud, a clinical research facility in Florida, has dosed its first patient as part of the Company’s ongoing Phase 2b trial.

IGC Pharma is currently conducting a Phase 2b trial at twelve sites in the US and Canada with IGC-AD1, a combination medicine with a CB1 receptor partial agonist with anti-neuroinflammatory properties, and an inflammasome inhibitor to treat agitation in dementia from Alzheimer’s. Neuroinflammation, neurotransmitter imbalance, loss of CB1 receptors, and inflammasome-3 have been implicated in agitation/aggression.

ClinCloud has two sites in Florida, one in Maitland and the other in Viera-Melbourne. Individuals diagnosed with Alzheimer’s disease and/or their caregivers who live near the sites are encouraged to contact ClinCloud for information regarding enrolling in the trial. Contact information is available at clincloudresearch.com.

Jessica Branning, founder of ClinCloud, commented, “Treatment options targeting agitation in Alzheimer’s disease are currently limited. This symptom is present in over 50-80% of Alzheimer’s patients and is a source of significant distress for both patients and their caregivers. We’re glad to support this Phase 2b clinical trial as it aligns with ClinCloud’s goal of transforming healthcare with continuous improvements and revolutionary breakthroughs. As the global population ages, it is more important than ever to identify treatments for neuropsychiatric conditions. An oral solution with the ability to reduce agitation in Alzheimer’s would have a significant impact on patients’ quality of life.”

Ram Mukunda, CEO of IGC Pharma stated, “We are excited to announce this important addition to our Phase 2b trial of IGC-AD1. This strategic expansion amplifies our reach and strengthens the depth of our data collection, marking a critical phase in our pursuit of an innovative therapy for agitation in Alzheimer's disease. The expansion of our trial network underscores our commitment to a robust, scientifically driven approach, advancing our confidence in the potential of IGC-AD1. We continue to see progress in patient and trial site recruitment. I am optimistic that our partnership with ClinCloud will bring us closer to developing an effective and safe therapy to address the global challenge of Alzheimer’s disease.”

IGC Pharma has 12 sites and is on target to roll out additional sites in the U.S. and in Canada to increase population diversity and promote the inclusion of underrepresented populations. The trial will enroll 146 patients with one half, the treated group, receiving IGC-AD1, and the other half, the control group, receiving a placebo.

About IGC Pharma, Inc.

IGC Pharma is pursuing innovative solutions to fight Alzheimer’s disease and related challenges. IGC Pharma’s portfolio comprises of five assets, all with a singular mission – to transform the landscape of Alzheimer’s treatment. IGC-AD1 and LMP target neuroinflammation, Aβ plaques, and neurofibrillary tangles. IGC-AD1 is a CB1r partial agonist currently in a Phase 2b clinical trial for agitation in dementia due to Alzheimer’s (clinicaltrials.gov, NCT05543681). TGR-63 targets Aβ plaque to disrupt the progression of Alzheimer’s disease. IGC-M3 targets the inhibition of Aβ plaque aggregation with the potential to create a profound impact on early-stage Alzheimer’s. IGC-1C targets tau and neurofibrillary tangles in a forward-thinking approach to Alzheimer’s therapy. In parallel, IGC Pharma is at the forefront of Generative AI development, with projects including clinical trials, early detection of Alzheimer’s, and drug interactions with cannabinoids.

About ClinCloud

ClinCloud Clinical Research, (https://www.clincloudresearch.com/) has 2 centers located in Viera-Melbourne and Maitland, Florida, with active clinical studies in Alzheimer’s disease, and other diseases.

Forward-looking Statements

This press release contains forward-looking statements. 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 U.S. Securities and Exchange Commission (“SEC”) filings. IGC Pharma incorporates by reference the human trial disclosures and Risk Factors identified in its Annual Report on Form 10-K filed with the SEC on July 7, 2023, as if fully incorporated and restated herein. Considering these risks and uncertainties, there can be no assurance that the forward-looking information contained in this release will occur.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240117772816/en/

Investors

IMS Investor Relations

Walter Frank

igc@imsinvestorrelations.com

(203) 972-9200

Media

JVPRNY

Janet Vasquez

jvasquez@jvprny.com

(212) 645-5498

Source: IGC Pharma, Inc.

FAQ

What is the ticker symbol for IGC Pharma, Inc.?

The ticker symbol for IGC Pharma, Inc. is IGC.

What is the Phase of the trial involving IGC-AD1?

The trial involving IGC-AD1 is a Phase 2b trial.

How many sites are involved in the Phase 2b trial for IGC-AD1?

IGC Pharma has 12 sites involved in the Phase 2b trial for IGC-AD1.

How many patients will be enrolled in the trial for IGC-AD1?

The trial will enroll 146 patients.

What is the goal of the Phase 2b trial for IGC-AD1?

The goal of the Phase 2b trial is to develop an innovative therapy for addressing agitation in Alzheimer's patients.

What is the role of ClinCloud in the trial for IGC-AD1?

ClinCloud has dosed its first patient as part of the ongoing Phase 2b trial for IGC-AD1.

What is the strategic expansion mentioned in the PR?

The strategic expansion aims to strengthen the depth of data collection and increase population diversity.

What is the CEO of IGC Pharma's statement regarding the trial?

The CEO of IGC Pharma expressed excitement about the important addition to the Phase 2b trial and the strategic expansion, marking a critical phase in the pursuit of an innovative therapy for agitation in Alzheimer's disease.