POTOMAC, Md.--(BUSINESS WIRE)--(NYSE American: IGC), India Globalization Capital, Inc. (“IGC” or the “Company”) today announced positive primary endpoint data for its Phase 1 clinical trial for IGC-AD1, which is a proprietary cannabinoid-based investigational new drug candidate for patients who have Alzheimer’s disease.
During the Phase 1 trial, minimal adverse events were reported, and IGC-AD1 was tolerated with no safety concerns identified by an independent Data Safety Monitoring Board. The Company has submitted the clinical trial data in its Clinical/Statistical Report (“CSR”) filed with the U.S. Food and Drug Administration (FDA) on December 1, 2021. In addition, as previously disclosed, data from the secondary and exploratory endpoints are also available on Form 8-K filed with the SEC on December 2, 2021.
In the short term, our strategy with IGC-AD1 is to demonstrate safety and tolerability, then, subject to FDA approval, to test and show efficacy in a large and diverse trial focused on symptoms associated with dementia in Alzheimer’s.
If our clinical trials satisfactorily demonstrate safety, tolerability, and efficacy, the Company’s goal is to apply to the FDA for approval of IGC-AD1 as a new drug.
The primary endpoint of our Phase 1 clinical trial was to test and demonstrate safety and tolerability. The trial was conducted as a multiple ascending dose (MAD) study. There were three Cohorts, with 12 patients in each cohort. Patients in Cohort 1, Cohort 2, and Cohort 3 received one, two, and three doses of IGC-AD1 per day, respectively, for 14 days.
The participants were a frail geriatric population with multiple comorbidities and mild to moderate Alzheimer’s disease. The average age was 80.9 years, and the average weight was 141.2 pounds. In addition, 66.7% of participants were women, and 33.3% were men. Safety and Tolerability (S&T) was assessed by asking participants to record Adverse Events (AEs). Participant recorded AEs included drowsiness (somnolence), falls, dizziness, weakness/lack of energy (asthenia), suicidal thoughts, hypertension, psychiatric symptoms, and paradoxical nausea. Each participant had a caregiver that assisted with the daily reporting. Using an FDA-defined protocol, the AEs were graded as mild, moderate, severe, life-threatening, and serious.
Across all three Cohorts, there were no serious or life-threatening AEs. There were no deaths, and no participant dropped out of the study due to the medication. Mild dizziness was reported by one patient in Cohort 1 that was deemed to be related to IGC-AD1. Apart from the mild dizziness, which self-resolved with no intervention, all other AEs across all three Cohorts were deemed unrelated to IGC-AD1 or the placebo.
The Company is encouraged by the data collected that indicates that even at the higher dosing levels tested in the Phase 1 trial, serious or life-threatening AEs did not result from the administration of ICG-AD1. Subject to FDA approval, the Company looks forward to continuing clinical trial testing of IGC-AD1 for safety, tolerability, and efficacy with the hope for a better life for people living with Alzheimer’s.
India Globalization Capital, Inc. (IGC), based in Maryland, engages in developing cannabinoid-based therapies for healthcare applications. The Company’s Life Science business recently completed a Phase 1 clinical trial on Alzheimer’s patients using a cannabinoid-based investigational new drug. The Company also operates an India-based infrastructure business. www.igcinc.us, www.igcpharma.com.
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934. These forward-looking statements are based largely on IGC’s expectations and are subject to several risks and uncertainties, certain of which are beyond IGC’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 investigational new drug or formulation described in this release, or failure to obtain FDA approval for the investigational new drug or additional clinical trials; testing results from human clinical trials that may not be favorable or as anticipated or consistent with the results obtained from Phase 1 trials; general economic conditions that are less favorable than expected, including as a result of the ongoing COVID-19 pandemic; the FDA’s general position regarding cannabis- and hemp-based products; and other factors, many of which are discussed in IGC’s SEC filings. IGC incorporates by reference the human trial disclosures and Risk Factors identified in its Annual Reports on Form 10-K filed with the SEC on June 14, 2021, and Quarterly Report on Form 10-Q, filed with the SEC on August 11, 2021, and October 29, 2021 as if fully incorporated and restated herein. In light of these risks and uncertainties, there can be no assurance that the forward-looking information contained in this release will occur.