IGC Pharma has added Hamilton Health Sciences (HHS) in Canada as a new clinical site for its ongoing, randomised Phase II CALMA trial of IGC-AD1 to treat agitation in Alzheimer’s disease.
This decision will help the company to progress the investigational cannabinoid-based therapy towards commercialisation.
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At the academic and research hospital, the double-blind trial will be led by geriatrician and HHS Geras Centre for Aging Research executive director Dr Alexandra Papaioannou.
IGC-AD1, the oral medication containing THC (Delta-9-Tetrahydrocannabinol) and melatonin, is administered two times daily to subjects aged 60 and above with mild to severe Alzheimer’s, who have shown clinically significant agitation for a minimum of two weeks before enrolment.
CALMA’s primary goal is to assess the therapy’s efficacy at treating agitation, with changes in the Cohen-Mansfield Agitation Inventory (CMAI) scores from baseline to the end of treatment serving as the main metric.
Secondary objectives will also be evaluated, including changes in CMAI scores from baseline to the two-week mark.
Blood samples will also be gathered in the trial for analysing sparse pharmacokinetic data, blood-based central nervous system (CNS) biomarkers, and genotyping.
With the addition of several trial sites across Canada and the US, including the University of Puerto Rico in August 2023, the company is focused on expediting subject enrolment and producing data to support the therapy’s regulatory approval and commercialisation.
IGC-AD1’s mechanism of action involves working as a partial cannabinoid receptor 1 (CB1) agonist with anti-neuroinflammatory properties, which may influence neuroinflammation, oxidative stress, and neurotransmitter imbalances.
IGC Pharma CEO Ram Mukunda said: “We are excited to welcome Hamilton Health Sciences as a site in the CALMA trial. Expanding the trial to this prestigious institution not only strengthens our study but also enhances patient access, accelerating our efforts to bring IGC-AD1 to market and deliver value for shareholders.”
