IGC Pharma's Puerto Rico CALMA Trial Site Offers Strategic Opportunity in High-Prevalence Alzheimer's Market
IGC Pharma (NYSE:IGC) has announced a new clinical trial site at Santa Cruz Behavioral (SCB) in Puerto Rico for its CALMA Phase 2 clinical trial, which is investigating IGC-AD1 for agitation in Alzheimer's disease. The strategic location addresses a significant market need, as Puerto Rico has a 12.5% Alzheimer's prevalence rate among those over 65, higher than the 10% rate in non-Hispanic white populations in the U.S.
The selection of Puerto Rico is particularly significant due to its rapidly aging demographic and unique genetic predispositions. Dementia-related medical care in Puerto Rico accounts for over 25% of total societal healthcare costs, exceeding proportions in the continental U.S. This new site complements IGC's existing trial location at the University of Puerto Rico.
IGC Pharma (NYSE:IGC) ha annunciato un nuovo sito per la sperimentazione clinica presso Santa Cruz Behavioral (SCB) a Porto Rico, dedicato al trial clinico di fase 2 CALMA, che studia IGC-AD1 per l'agitazione nella malattia di Alzheimer. Questa scelta strategica risponde a una forte esigenza di mercato, dato che Porto Rico presenta un tasso di prevalenza dell'Alzheimer del 12,5% tra gli over 65, superiore al 10% riscontrato nelle popolazioni bianche non ispaniche degli Stati Uniti.
La selezione di Porto Rico è particolarmente rilevante per la sua popolazione che invecchia rapidamente e per le specifiche predisposizioni genetiche. Le cure mediche legate alla demenza a Porto Rico rappresentano oltre il 25% dei costi sanitari totali della società, superando le percentuali registrate negli Stati Uniti continentali. Questo nuovo sito si affianca a quello già esistente presso l'Università di Porto Rico.
IGC Pharma (NYSE:IGC) ha anunciado un nuevo sitio para ensayo clínico en Santa Cruz Behavioral (SCB) en Puerto Rico para su ensayo clínico de fase 2 CALMA, que investiga IGC-AD1 para la agitación en la enfermedad de Alzheimer. Esta ubicación estratégica responde a una necesidad significativa del mercado, ya que Puerto Rico presenta una tasa de prevalencia de Alzheimer del 12,5% entre mayores de 65 años, superior al 10% en poblaciones blancas no hispanas en EE.UU.
La elección de Puerto Rico es especialmente importante debido a su demografía que envejece rápidamente y a predisposiciones genéticas únicas. La atención médica relacionada con la demencia en Puerto Rico representa más del 25% del costo total de la atención sanitaria a nivel social, superando las proporciones del territorio continental de EE.UU. Este nuevo sitio complementa la ubicación de ensayo existente de IGC en la Universidad de Puerto Rico.
IGC Pharma (NYSE:IGC)는 푸에르토리코의 Santa Cruz Behavioral(SCB)에 새로운 임상시험 사이트를 개설했다고 발표했습니다. 이 사이트는 알츠하이머병의 초조증을 치료하기 위한 CALMA 2상 임상시험에서 IGC-AD1을 연구하는 곳입니다. 푸에르토리코는 65세 이상 인구 중 알츠하이머 유병률이 12.5%로, 미국 내 비히스패닉 백인 인구의 10%보다 높아 중요한 시장 요구를 반영한 전략적 위치입니다.
푸에르토리코의 선택은 빠르게 고령화되는 인구 구조와 독특한 유전적 소인 때문에 특히 중요합니다. 푸에르토리코에서 치매 관련 의료비는 전체 사회 의료비의 25% 이상을 차지하며, 이는 미국 본토보다 높은 비율입니다. 이 새로운 사이트는 IGC가 기존에 보유한 푸에르토리코 대학교 임상시험 장소를 보완합니다.
IGC Pharma (NYSE:IGC) a annoncé un nouveau site d'essai clinique chez Santa Cruz Behavioral (SCB) à Porto Rico pour son essai clinique de phase 2 CALMA, qui étudie IGC-AD1 pour l'agitation dans la maladie d'Alzheimer. Cet emplacement stratégique répond à un besoin important du marché, car Porto Rico présente un taux de prévalence de la maladie d'Alzheimer de 12,5% chez les plus de 65 ans, supérieur au taux de 10% chez les populations blanches non hispaniques aux États-Unis.
Le choix de Porto Rico est particulièrement significatif en raison de sa population vieillissante rapide et de prédispositions génétiques uniques. Les soins médicaux liés à la démence à Porto Rico représentent plus de 25% des coûts totaux de santé de la société, dépassant les proportions observées dans le reste des États-Unis. Ce nouveau site complète le site d'essai existant d'IGC à l'Université de Porto Rico.
IGC Pharma (NYSE:IGC) hat einen neuen Standort für klinische Studien bei Santa Cruz Behavioral (SCB) in Puerto Rico für seine CALMA Phase-2-Studie bekannt gegeben, die IGC-AD1 bei Unruhe im Zusammenhang mit Alzheimer untersucht. Die strategische Lage adressiert einen bedeutenden Marktbedarf, da Puerto Rico eine Alzheimer-Prävalenz von 12,5% bei Personen über 65 Jahren aufweist, höher als die 10% bei nicht-hispanischen weißen Bevölkerungsgruppen in den USA.
Die Wahl von Puerto Rico ist besonders bedeutsam aufgrund der schnell alternden Bevölkerung und einzigartiger genetischer Prädispositionen. Die medizinische Versorgung im Zusammenhang mit Demenz macht in Puerto Rico über 25% der gesamten gesellschaftlichen Gesundheitskosten aus, was die Anteile im Festland-USA übersteigt. Dieser neue Standort ergänzt den bestehenden Studienstandort der IGC an der Universität von Puerto Rico.
- Strategic expansion into a high-prevalence market with 12.5% Alzheimer's rate in elderly population
- Partnership with established healthcare provider Santa Cruz Behavioral enhances trial diversity
- Access to underserved population could improve commercial viability and regulatory success
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Insights
IGC's new Puerto Rico trial site strategically targets a high-prevalence Alzheimer's population, enhancing trial diversity and commercial potential.
The announcement of IGC Pharma's additional Puerto Rico clinical trial site reveals a calculated strategic approach to their Phase 2 CALMA trial investigating IGC-AD1 for Alzheimer's-related agitation. The company is specifically targeting a region with 12.5% Alzheimer's prevalence among seniors—significantly higher than the ~10% seen in non-Hispanic white U.S. populations.
This site expansion demonstrates sophisticated clinical development strategy for several reasons. First, the higher disease prevalence provides a larger potential patient pool, which could accelerate enrollment and potentially reduce time-to-completion for the trial. Second, Puerto Rico represents a population with distinct genetic factors influencing Alzheimer's development, allowing IGC to gather data on treatment response across genetically diverse populations.
From a regulatory perspective, this approach aligns with the FDA's increasing emphasis on diversity in clinical trials. Showing efficacy across varied populations strengthens the eventual submission package and addresses potential genetic variables in treatment response. The Santa Cruz Behavioral site complements their existing University of Puerto Rico location, creating a more robust geographic footprint within this high-prevalence region.
For a Phase 2 trial, this methodical site selection demonstrates strategic foresight regarding both the immediate clinical development goals and longer-term commercial positioning. If IGC-AD1 demonstrates efficacy for Alzheimer's agitation—a significant unmet need with limited treatment options—having already established presence in high-prevalence markets could facilitate eventual commercialization efforts.
POTOMAC, MD / ACCESS Newswire / May 22, 2025 / IGC Pharma, Inc. ("IGC", or the "Company") (NYSE American:IGC) today announced a clinical trial site at Santa Cruz Behavioral in Puerto Rico for its CALMA Phase 2 clinical trial, investigating IGC-AD1 for agitation in Alzheimer's disease. This strategic site directly addresses the significant impact of Alzheimer's in the region.
Approximately
"We're pleased to work with Santa Cruz Behavioral ("SCB") as a trial site for our CALMA study, expanding our reach in Puerto Rico alongside a previously announced site at the University of Puerto Rico," said Ram Mukunda, CEO of IGC Pharma. "Puerto Rico represents a high-need and underserved population in Alzheimer's care, and SCB strengthens our ability to evaluate IGC-AD1 across diverse patient populations. Diversity in clinical trials not only improves scientific validity but also supports broader regulatory and commercial success."
For IGC Pharma's investors, this initiative represents a strategic imperative. By engaging a vast, underserved market with a high disease prevalence, diverse clinical trials are not only ethically sound but also enhance the commercial viability of therapies by ensuring universal effectiveness.
Santa Cruz Behavioral in Puerto Rico, known for its outstanding mental healthcare services from a biopsychosocial perspective, serves as a key partner in this endeavor.
Patients and caregivers interested in participating in the CALMA trial should please contact Santa Cruz Behavioral in Bayamon Puerto Rico.
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
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 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 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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