IGC Pharma Expands CALMA Alzheimer's Phase 2 Trial with Prestigious Research Site at Butler Hospital's Memory and Aging Program
IGC Pharma (NYSE American:IGC) has expanded its Phase 2 CALMA clinical trial by adding Butler Hospital's Memory and Aging Program, affiliated with Brown University's Warren Alpert Medical School. The trial evaluates IGC-AD1, a therapy for agitation in Alzheimer's disease.
Dr. Meghan Riddle, Associate Director of Butler Hospital's Memory and Aging Program and Associate Professor, will lead the trial site. The CALMA study aims to enroll 146 participants across the United States and Canada to assess IGC-AD1's effectiveness in reducing agitation in Alzheimer's patients, a condition affecting most patients and significantly impacting caregivers.
Butler Hospital's Memory and Aging Program is recognized nationally for Alzheimer's research, focusing on prevention, diagnosis, and treatment of neurodegenerative diseases.
IGC Pharma (NYSE American:IGC) ha ampliato il suo studio clinico di Fase 2 CALMA aggiungendo il Programma di Memoria e Invecchiamento dell'Ospedale Butler, affiliato alla Warren Alpert Medical School della Brown University. Lo studio valuta l'IGC-AD1, una terapia per l'agitazione nella malattia di Alzheimer.
La Dott.ssa Meghan Riddle, Direttrice Associata del Programma di Memoria e Invecchiamento dell'Ospedale Butler e Professoressa Associata, guiderà il sito dello studio. Lo studio CALMA mira a reclutare 146 partecipanti negli Stati Uniti e in Canada per valutare l'efficacia dell'IGC-AD1 nella riduzione dell'agitazione nei pazienti affetti da Alzheimer, una condizione che colpisce la maggior parte dei pazienti e ha un impatto significativo sui caregiver.
Il Programma di Memoria e Invecchiamento dell'Ospedale Butler è riconosciuto a livello nazionale per la ricerca sull'Alzheimer, con un focus sulla prevenzione, diagnosi e trattamento delle malattie neurodegenerative.
IGC Pharma (NYSE American:IGC) ha ampliado su ensayo clínico de Fase 2 CALMA al añadir el Programa de Memoria y Envejecimiento del Hospital Butler, afiliado a la Escuela de Medicina Warren Alpert de la Universidad de Brown. El ensayo evalúa el IGC-AD1, una terapia para la agitación en la enfermedad de Alzheimer.
La Dra. Meghan Riddle, Directora Asociada del Programa de Memoria y Envejecimiento del Hospital Butler y Profesora Asociada, liderará el sitio del ensayo. El estudio CALMA tiene como objetivo inscribir a 146 participantes en los Estados Unidos y Canadá para evaluar la efectividad del IGC-AD1 en la reducción de la agitación en pacientes con Alzheimer, una condición que afecta a la mayoría de los pacientes y tiene un impacto significativo en los cuidadores.
El Programa de Memoria y Envejecimiento del Hospital Butler es reconocido a nivel nacional por su investigación sobre el Alzheimer, centrándose en la prevención, diagnóstico y tratamiento de enfermedades neurodegenerativas.
IGC Pharma (NYSE American:IGC)는 브라운 대학교 워렌 알퍼트 의과대학에 소속된 버틀러 병원의 기억 및 노화 프로그램을 추가하여 2상 CALMA 임상 시험을 확장했습니다. 이 시험은 알츠하이머병에서의 불안정성을 치료하기 위한 요법인 IGC-AD1을 평가합니다.
버틀러 병원의 기억 및 노화 프로그램의 부소장인 메간 리들 박사가 시험 사이트를 이끌 것입니다. CALMA 연구는 미국과 캐나다 전역에서 146명의 참가자를 모집하여 알츠하이머 환자의 불안정성을 줄이는 데 있어 IGC-AD1의 효과를 평가하는 것을 목표로 하고 있으며, 이 상태는 대부분의 환자에게 영향을 미치고 간병인에게 상당한 영향을 미칩니다.
버틀러 병원의 기억 및 노화 프로그램은 알츠하이머 연구로 전국적으로 인정받고 있으며, 신경퇴행성 질환의 예방, 진단 및 치료에 중점을 두고 있습니다.
IGC Pharma (NYSE American:IGC) a élargi son essai clinique de Phase 2 CALMA en ajoutant le Programme de Mémoire et de Vieillissement de l'Hôpital Butler, affilié à l'École de Médecine Warren Alpert de l'Université Brown. L'essai évalue l'IGC-AD1, une thérapie pour l'agitation dans la maladie d'Alzheimer.
La Dr Meghan Riddle, Directrice Associée du Programme de Mémoire et de Vieillissement de l'Hôpital Butler et Professeure Associée, dirigera le site de l'essai. L'étude CALMA vise à recruter 146 participants aux États-Unis et au Canada pour évaluer l'efficacité de l'IGC-AD1 dans la réduction de l'agitation chez les patients atteints d'Alzheimer, une condition qui touche la plupart des patients et a un impact significatif sur les aidants.
Le Programme de Mémoire et de Vieillissement de l'Hôpital Butler est reconnu au niveau national pour ses recherches sur l'Alzheimer, en se concentrant sur la prévention, le diagnostic et le traitement des maladies neurodégénératives.
IGC Pharma (NYSE American:IGC) hat seine Phase-2-Studie CALMA erweitert, indem das Gedächtnis- und Altersprogramm des Butler Hospitals, das mit der Warren Alpert Medical School der Brown University verbunden ist, hinzugefügt wurde. Die Studie bewertet IGC-AD1, eine Therapie gegen Unruhe bei Alzheimer-Patienten.
Dr. Meghan Riddle, stellvertretende Direktorin des Gedächtnis- und Altersprogramms des Butler Hospitals und außerordentliche Professorin, wird die Studienstelle leiten. Die CALMA-Studie zielt darauf ab, 146 Teilnehmer in den Vereinigten Staaten und Kanada zu rekrutieren, um die Wirksamkeit von IGC-AD1 bei der Reduzierung von Unruhe bei Alzheimer-Patienten zu bewerten, eine Bedingung, die die meisten Patienten betrifft und erhebliche Auswirkungen auf die Betreuer hat.
Das Gedächtnis- und Altersprogramm des Butler Hospitals ist national anerkannt für seine Forschung zu Alzheimer und konzentriert sich auf die Prävention, Diagnose und Behandlung neurodegenerativer Erkrankungen.
- Expansion of Phase 2 trial to prestigious research center affiliated with Brown University
- Addition of nationally recognized research site enhances trial credibility
- Trial addresses major unmet need in Alzheimer's disease management
- None.
Insights
IGC Pharma's expansion of its Phase 2 CALMA trial to include Butler Hospital's Memory and Aging Program represents incremental progress in the company's clinical development program for IGC-AD1. The addition of this prestigious research site affiliated with Brown University may enhance patient recruitment capabilities and bring valuable expertise through Dr. Meghan Riddle, whose background in geriatric psychiatry and neuropsychiatric symptoms of dementia aligns precisely with the trial's focus on Alzheimer's-related agitation.
This development, while positive for operational execution, represents a standard clinical trial expansion rather than a transformative milestone. The CALMA trial aims to enroll 146 participants across sites in the US and Canada, targeting agitation symptoms that affect the majority of Alzheimer's patients. For a micro-cap company (
However, investors should note that site expansion announcements, while necessary for trial progress, don't provide efficacy signals or accelerate the timeline to potential commercialization. The Alzheimer's therapeutic landscape remains highly competitive and challenging, with numerous clinical failures historically. IGC-AD1 still faces the significant hurdles of demonstrating efficacy and safety in the current trial before potentially advancing to pivotal studies.
POTOMAC, MARYLAND / ACCESS Newswire / April 8, 2025 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC Pharma" or the "Company") today announced the expansion of its ongoing Phase 2 CALMA clinical trial with the addition of Butler Hospital's Memory and Aging Program, a nationally recognized research center affiliated with the Warren Alpert Medical School of Brown University, in Providence, Rhode Island. The site will support enrollment for the CALMA study evaluating IGC-AD1, IGC Pharma's investigational therapy for agitation in Alzheimer's disease, a condition affecting a majority of Alzheimer's patients and significantly impacting caregivers.
Dr. Meghan Riddle, Associate Director of Butler Hospital's Memory and Aging Program and Associate Professor at The Warren Alpert Medical School of Brown University, will lead the trial at Butler. A geriatric psychiatrist, Dr. Riddle specializes in late-life mood disorders and neuropsychiatric symptoms related to dementia, bringing deep clinical and research expertise to the CALMA trial.
Butler Hospital's Memory and Aging Program ("MAP") is a nationally recognized leader in Alzheimer's research, dedicated to the prevention, diagnosis, and treatment of neurodegenerative diseases. The program provides comprehensive care for individuals and families affected by Alzheimer's, dementia, and memory loss, while advancing the field through cutting-edge clinical research and innovation in treatment strategies.
"We are excited to collaborate with Butler Hospital's Memory and Aging Program in advancing the CALMA clinical trial," said Ram Mukunda, CEO of IGC Pharma. "Their commitment to innovative patient care and cutting-edge research makes them a valuable partner in our mission to address the challenges of agitation in Alzheimer's patients. This expansion marks another important step in progressing our trial, bringing us closer to potential commercializing effective solutions for patients in need."
IGC Pharma's CALMA Phase 2 trial is being conducted in the United States, and Canada, with a goal of enrolling 146 participants. The study aims to evaluate IGC-AD1's potential in reducing agitation in Alzheimer's dementia, one of the most difficult-to-manage aspects of Alzheimer's disease.
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 55 patent filings and a commitment to innovation, IGC Pharma is advancing breakthrough therapies. Additionally, the Company operates Holiby™, a wellness brand offering scientifically formulated products for immunity, energy, and longevity.
About the Memory and Aging Program at Butler Hospital:
The Memory & Aging Program (MAP) at Butler Hospital is a worldwide leader in Alzheimer's disease research and a local Rhode Island partner in the fight against Alzheimer's and other forms of dementia. An affiliate of The Warren Alpert Medical School of Brown University, MAP has a 25-year history of excellence in Alzheimer's clinical care, training, and research aimed at developing new and better ways to detect, treat, and someday even prevent Alzheimer's. Individuals who wish to be considered for participation in current and future research studies and clinical trials conducted at the Memory and Aging Program for the prevention and treatment of Alzheimer's disease can join the program's Alzheimer's Prevention Registry at Butler Hospital online at butler.org/ALZregistry or by calling (401) 455-6402. For more information visit butler.org/memory and follow on Facebook and Twitter.
About Butler Hospital:
Butler Hospital, a member of Care New England, is the only private, nonprofit psychiatric and substance abuse hospital serving adults, seniors and adolescents in Rhode Island and southeastern New England. Founded in 1844, it was the first hospital in Rhode Island and has earned a reputation as the leading provider of innovative psychiatric treatments in the region. The Major Affiliated Teaching Hospital for Psychiatry and Behavioral Health at The Warren Alpert Medical School of Brown University, Butler is recognized worldwide as a pioneer in conducting cutting-edge research. For more information, visit butler.org.
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 24, 2024, and on Form 10-Qs filed with the SEC on August 7, 2024, November 12, 2024, and February 14, 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.
Contact Information
Rosalyn Christian / Walter Frank
IMS Investor Relations
igc@imsinvestorrelations.com
(203) 972-9200
SOURCE: IGC Pharma, Inc.
View the original press release on ACCESS Newswire
FAQ
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