IGC Pharma Expands CALMA Phase 2 Trial to Island Health's Royal Jubilee Hospital in Canada
IGC Pharma (NYSE American:IGC) announced the expansion of its Phase 2 CALMA clinical trial for IGC-AD1, a novel treatment for agitation in Alzheimer's dementia, to Island Health's Royal Jubilee Hospital in Victoria, British Columbia, Canada.
The CALMA trial is designed as a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of IGC-AD1 in managing agitation in Alzheimer's patients. This expansion strengthens the trial's clinical infrastructure across North America and aims to increase access for patients and caregivers while supporting timely enrollment towards trial completion.
IGC Pharma (NYSE American:IGC) ha annunciato l'ampliamento del suo trial clinico di Fase 2 CALMA per IGC-AD1, un nuovo trattamento per l'agitazione nella demenza di Alzheimer, presso il Royal Jubilee Hospital di Island Health a Victoria, British Columbia, Canada.
Lo studio CALMA è concepito come uno studio randomizzato, in doppio cieco e controllato con placebo per valutare la sicurezza e l'efficacia di IGC-AD1 nel controllo dell'agitazione nei pazienti con Alzheimer. Questa estensione rafforza l'infrastruttura clinica del trial in Nord America e punta ad aumentare l'accesso per pazienti e caregiver, favorendo al contempo un arruolamento tempestivo verso il completamento dello studio.
IGC Pharma (NYSE American:IGC) anunció la ampliación de su ensayo clínico de Fase 2 CALMA para IGC-AD1, un nuevo tratamiento para la agitación en la demencia por Alzheimer, al Royal Jubilee Hospital de Island Health en Victoria, Columbia Británica, Canadá.
El ensayo CALMA está diseñado como un estudio aleatorizado, doble ciego y controlado con placebo para evaluar la seguridad y eficacia de IGC-AD1 en el manejo de la agitación en pacientes con Alzheimer. Esta expansión refuerza la infraestructura clínica del ensayo en Norteamérica y busca aumentar el acceso para pacientes y cuidadores, además de apoyar un reclutamiento oportuno hacia la finalización del estudio.
IGC Pharma (NYSE American:IGC)는 알츠하이머 치매 환자의 초조·불안 증상 치료를 위한 새로운 약물 IGC-AD1의 2상 CALMA 임상시험을 캐나다 브리티시컬럼비아주 빅토리아의 Island Health 소속 로열 주빌리 병원(Royal Jubilee Hospital)으로 확대한다고 발표했습니다.
CALMA 시험은 IGC-AD1의 안전성과 유효성을 평가하기 위해 무작위배정, 이중맹검, 위약대조 연구로 설계되었습니다. 이번 확대는 북미 전역의 임상 인프라를 강화하고 환자와 보호자의 접근성을 높이며, 시험 완료를 위한 적시 등록을 지원하는 것을 목표로 합니다.
IGC Pharma (NYSE American:IGC) a annoncé l'extension de son essai clinique de phase 2 CALMA pour IGC‑AD1, un nouveau traitement de l'agitation liée à la démence d'Alzheimer, au Royal Jubilee Hospital d'Island Health à Victoria, Colombie‑Britannique, Canada.
L'essai CALMA est conçu comme une étude randomisée, en double aveugle et contrôlée par placebo visant à évaluer la sécurité et l'efficacité d'IGC‑AD1 dans la prise en charge de l'agitation chez les patients atteints d'Alzheimer. Cette extension renforce l'infrastructure clinique de l'étude en Amérique du Nord et vise à améliorer l'accès pour les patients et aidants, tout en favorisant un recrutement rapide jusqu'à l'achèvement de l'essai.
IGC Pharma (NYSE American:IGC) gab bekannt, dass die Phase‑2‑CALMA‑Studie für IGC‑AD1, eine neuartige Behandlung von Agitation bei Alzheimer‑Demenz, auf das Royal Jubilee Hospital von Island Health in Victoria, British Columbia, Kanada, ausgeweitet wird.
Die CALMA‑Studie ist als randomisierte, doppelblinde, placebokontrollierte Untersuchung angelegt, um die Sicherheit und Wirksamkeit von IGC‑AD1 bei der Behandlung von Agitation bei Alzheimer‑Patienten zu prüfen. Diese Erweiterung stärkt die klinische Infrastruktur der Studie in Nordamerika und soll den Zugang für Patienten und Betreuer verbessern sowie ein zügiges Einschreiben zur Studienvollendung unterstützen.
- Expansion to international site in Canada broadens patient population diversity
- Addition of experienced research center strengthens clinical trial infrastructure
- Progress in Phase 2 trial development and geographical expansion
- None.
Insights
IGC Pharma's expansion of its Alzheimer's agitation treatment trial to Canada broadens patient access and strengthens its clinical development program.
IGC Pharma has expanded its CALMA Phase 2 clinical trial for IGC-AD1, an investigational treatment for agitation in Alzheimer's dementia, to Island Health's Royal Jubilee Hospital in Victoria, British Columbia. This international expansion represents a significant step in the company's clinical development program.
The CALMA trial is designed as a randomized, double-blind, placebo-controlled study - the gold standard methodology for clinical research. This rigorous design will provide high-quality data on both safety and efficacy endpoints for IGC-AD1 in managing Alzheimer's-related agitation.
Agitation in Alzheimer's is a particularly challenging neuropsychiatric symptom that significantly impacts both patient quality of life and caregiver burden. Currently, there are limited FDA-approved treatment options specifically for Alzheimer's agitation, making this an area of substantial unmet medical need.
The expansion to Canada serves multiple strategic purposes: it diversifies the patient population, potentially accelerates enrollment timelines, and strengthens the overall robustness of the clinical data package. Multi-site, international trials are typically viewed favorably by regulatory agencies as they demonstrate effectiveness across diverse populations.
While this expansion indicates positive operational progress, investors should note that this remains a Phase 2 trial, which means IGC-AD1 still faces significant development hurdles before potential commercialization, including a pivotal Phase 3 program and regulatory review.
POTOMAC, MD / ACCESS Newswire / September 2, 2025 / IGC Pharma, Inc. (NYSE American:IGC) today announced expansion of its ongoing Phase 2 clinical trial evaluating IGC-AD1, a novel investigational treatment for agitation in Alzheimer's dementia, to a new international site at Island Health's Royal Jubilee Hospital in Victoria, British Columbia, Canada.
"Bringing CALMA to Canada is a milestone in our mission to offer innovative solutions for individuals living with Alzheimer's disease," said Ram Mukunda, CEO of IGC Pharma. "This expansion reflects the CALMA trial's continued growth across North America, broadening access to diverse patient populations and reinforcing IGC's commitment to advancing IGC-AD1 through a robust, multi-site clinical program. We are honored to collaborate with the experienced team at Island Health to reach more families affected by this condition."
This marks the CALMA trial's continued growth across North America, aiming to increase access for patients and caregivers affected by Alzheimer's disease and its neuropsychiatric symptoms. The addition of Royal Jubilee Hospital strengthens the trial's clinical infrastructure and supports timely enrollment as the Company works toward trial completion.
The CALMA Phase 2 trial is a randomized, double-blind, placebo-controlled study designed to assess the safety and efficacy of IGC-AD1 in managing agitation in patients with Alzheimer's disease, a symptom that significantly impacts quality of life and care outcomes.
Island Health's Clinical Trials Unit at Royal Jubilee Hospital is now actively involved in the CALMA study. For site inquiries or additional information, please contact:
Clinical Research Coordinator
Royal Jubilee Hospital
1952 Bay Street - Memorial Pavilion - Kenning Wing 1st Floor
Victoria, BC V8R 1J8
Phone: 250.370.8340 or 250-519-7700 Ext: 13511
To learn more about IGC Pharma and the CALMA trial, please visit www.igcpharma.com.
About Island Health
Island Health is one of British Columbia's five regional health authorities, providing comprehensive health care services to more than 850,000 residents across Vancouver Island, the Gulf Islands, and parts of the mainland. The Clinical Trials Unit at Royal Jubilee Hospital in Victoria is a leading center for medical research, dedicated to advancing clinical innovation and patient-centered care. Through partnerships with academic institutions and global sponsors, Island Health contributes to the development of evidence-based treatments that improve outcomes and enhance quality of life.
About IGC Pharma (dba IGC):
IGC Pharma (NYSE American:IGC) is a clinical-stage biotechnology company leveraging AI to develop innovative treatments for Alzheimer's and metabolic disorders. Our lead asset, IGC-AD1, is a cannabinoid-based therapy currently in a Phase 2 trial (CALMA) for agitation in Alzheimer's dementia. Our pipeline includes TGR-63, targeting amyloid plaques, and early-stage programs focused on neurodegeneration, tau proteins, and metabolic dysfunctions. We integrate AI to accelerate drug discovery, optimize clinical trials, and enhance patient targeting. With 30 patent filings and a commitment to innovation, IGC Pharma is advancing breakthrough therapies.
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 incorporates by reference its Annual Report on Form 10-K filed with the SEC on June 27, 2025, 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. IGC Pharma, Inc. assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
Contact Information
Rosalyn Christian / John Nesbett
IMS Investor Relations
igc@imsinvestorrelations.com
(203) 972-9200
SOURCE: IGC Pharma, Inc.
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