IGC Pharma Announces CALMA Phase 2 Trial Expansion with the Addition of Miami Jewish Health
IGC Pharma (NYSE American:IGC) has expanded its Phase 2 CALMA clinical trial for IGC-AD1, a treatment targeting agitation in Alzheimer's dementia, by adding the MIND Institute at Miami Jewish Health as a new trial site. The expansion follows promising interim data suggesting potential improvements in patient outcomes.
Miami Jewish Health, with over 85 years of experience in senior healthcare, will contribute to the study under the leadership of Dr. Marc E. Agronin, Chief Medical Officer of MIND Institute and a renowned geriatric psychiatrist. This collaboration aims to accelerate trial completion while reaching a more diverse patient population.
IGC Pharma (NYSE American:IGC) ha ampliato il suo trial clinico di Fase 2 CALMA per IGC-AD1, un trattamento mirato all'agitazione nella demenza di Alzheimer, aggiungendo l'Istituto MIND presso il Miami Jewish Health come nuovo sito di sperimentazione. L'espansione segue dati interinali promettenti che suggeriscono potenziali miglioramenti nei risultati per i pazienti.
Il Miami Jewish Health, con oltre 85 anni di esperienza nella salute degli anziani, contribuirà allo studio sotto la guida del Dr. Marc E. Agronin, Direttore Medico dell'Istituto MIND e rinomato psichiatra geriatrico. Questa collaborazione mira ad accelerare il completamento della sperimentazione raggiungendo una popolazione di pazienti più diversificata.
IGC Pharma (NYSE American:IGC) ha ampliado su ensayo clínico de Fase 2 CALMA para IGC-AD1, un tratamiento dirigido a la agitación en la demencia de Alzheimer, añadiendo el Instituto MIND en Miami Jewish Health como un nuevo sitio de ensayo. La expansión sigue a datos interinos prometedores que sugieren mejoras potenciales en los resultados de los pacientes.
Miami Jewish Health, con más de 85 años de experiencia en atención médica para ancianos, contribuirá al estudio bajo la dirección del Dr. Marc E. Agronin, Director Médico del Instituto MIND y reconocido psiquiatra geriátrico. Esta colaboración tiene como objetivo acelerar la finalización del ensayo mientras se alcanza una población de pacientes más diversa.
IGC Pharma (NYSE American:IGC)는 알츠하이머 치매의 불안을 목표로 하는 치료제 IGC-AD1의 2상 CALMA 임상 시험을 확장하여 마이애미 유대인 건강의 MIND 연구소를 새로운 시험 장소로 추가했습니다. 이번 확장은 환자 결과의 잠재적 개선을 시사하는 유망한 중간 데이터를 바탕으로 이루어졌습니다.
마이애미 유대인 건강은 노인 의료 분야에서 85년 이상의 경험을 가지고 있으며, MIND 연구소의 최고 의료 책임자인 Marc E. Agronin 박사의 지도 아래 연구에 기여할 것입니다. 이 협력은 시험 완료를 가속화하고 더 다양한 환자 집단에 도달하는 것을 목표로 하고 있습니다.
IGC Pharma (NYSE American:IGC) a élargi son essai clinique de Phase 2 CALMA pour IGC-AD1, un traitement ciblant l'agitation dans la démence d'Alzheimer, en ajoutant l'Institut MIND au Miami Jewish Health en tant que nouveau site d'essai. Cette expansion fait suite à des données intermédiaires prometteuses suggérant des améliorations potentielles des résultats pour les patients.
Miami Jewish Health, fort de plus de 85 ans d'expérience dans les soins aux personnes âgées, contribuera à l'étude sous la direction du Dr. Marc E. Agronin, Directeur Médical de l'Institut MIND et psychiatre gériatrique de renom. Cette collaboration vise à accélérer l'achèvement de l'essai tout en atteignant une population de patients plus diversifiée.
IGC Pharma (NYSE American:IGC) hat seine Phase 2 CALMA-Studie für IGC-AD1, eine Behandlung zur Bekämpfung von Unruhe bei Alzheimer-Demenz, erweitert, indem das MIND Institute des Miami Jewish Health als neuer Prüfstandort hinzugefügt wurde. Die Erweiterung folgt auf vielversprechende Zwischenberichte, die auf potenzielle Verbesserungen der Patientenresultate hinweisen.
Miami Jewish Health, das über 85 Jahre Erfahrung in der Seniorenmedizin verfügt, wird unter der Leitung von Dr. Marc E. Agronin, Chief Medical Officer des MIND Institute und einem renommierten Geriater, zur Studie beitragen. Diese Zusammenarbeit zielt darauf ab, den Abschluss der Studie zu beschleunigen und eine diversere Patientengruppe zu erreichen.
- Expansion of Phase 2 trial with addition of established research center
- Promising interim data reported for IGC-AD1
- Partnership with experienced institution (85+ years) specializing in senior care
- None.
Insights
IGC Pharma's expansion of its Phase 2 CALMA trial to Miami Jewish Health represents incremental progress in their clinical development program for IGC-AD1, targeting agitation in Alzheimer's dementia patients. The addition of this respected institution—specifically their MIND Institute led by notable geriatric psychiatrist Dr. Marc Agronin—suggests the company is executing its clinical strategy effectively.
The announcement references "promising interim data" but provides no specific efficacy metrics or statistical significance information, making it impossible to quantify the treatment's current performance. This language typically indicates some positive signals in early data, but without details, we can't assess the magnitude of benefit.
From a development perspective, increasing trial sites can accelerate enrollment and potentially reduce time to completion, which may modestly expedite the path to potential commercialization if results prove positive. The collaboration with Miami Jewish Health could enhance patient diversity, potentially strengthening the dataset's robustness and applicability across broader populations.
This development represents standard progress in mid-stage clinical trials rather than a transformative milestone. While the expansion demonstrates operational execution, it doesn't fundamentally alter the risk profile of IGC-AD1 or provide new information about the treatment's efficacy that would significantly impact investor outlook.
POTOMAC, MARYLAND / ACCESS Newswire / April 1, 2025 / IGC Pharma, Inc. (NYSE American:IGC) today announced the expansion of its Phase 2 clinical trial, CALMA, evaluating IGC-AD1 for the treatment of agitation in Alzheimer's dementia, to MIND Institute at Miami Jewish Health in Miami, Florida. This addition further advances the company's efforts to accelerate the trial's completion and builds on promising interim data suggesting the potential of IGC-AD1 to improve patient outcomes.
Miami Jewish Health specializes in healthcare and living options for seniors, providing services for more than 85 years and hosting cutting-edge Alzheimer's disease clinical trials. The organization is dedicated to advancing research and innovative treatments for neurocognitive disorders, improving care for individuals living with Alzheimer's and related conditions.
Ram Mukunda, CEO of IGC Pharma commented, "The addition of MIND Institute at Miami Jewish Health as a trial site strengthens our ability to reach a broader and more diverse patient population while accelerating the path toward regulatory approval. Their commitment to excellence in senior care and clinical research aligns with our mission, and we are excited to collaborate with their highly experienced team."
The trial at Miami Jewish Health will be led by Dr. Marc E. Agronin, a nationally recognized geriatric psychiatrist and Chief Medical Officer of MIND Institute. Dr. Agronin has dedicated his career to advancing neurocognitive research and improving the lives of older adults through innovative care models.
"Alzheimer's disease impacts millions of families, and effective treatments for agitation remain a critical unmet need," said Dr. Agronin. "At MIND Institute at Miami Jewish Health, we are proud to contribute to this important study, which has the potential to improve care and enhance quality of life for individuals living with Alzheimer's."
About IGC-AD1 and the CALMA Trial
IGC-AD1 is IGC Pharma's investigational cannabinoid-based therapy currently in a Phase 2 multicenter, double-blind, randomized, placebo-controlled study (CALMA) evaluating its safety and efficacy for treating agitation in Alzheimer's dementia. Agitation affects up to
With multiple trial sites now active across the U.S. and Canada, IGC Pharma remains focused on accelerating patient enrollment and generating data that could support regulatory approval and commercialization of IGC-AD1.
For more information on the CALMA trial, visit: ClinicalTrials.gov.
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.
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
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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