IGC Pharma Expands CALMA Trial with Addition of BayCare Health System in Florida
IGC Pharma (NYSE American:IGC) has expanded its Phase 2 CALMA trial for IGC-AD1, adding BayCare's St. Anthony's Hospital in St. Petersburg, Florida as a new trial site. IGC-AD1 is a combination therapy targeting agitation in Alzheimer's dementia, which affects up to 76% of patients.
The trial will be led by Dr. Michael A. Franklin, a board-certified neurologist at St. Anthony's Hospital. The ongoing 146-patient Phase 2 trial has shown promising interim results, including significant reductions in agitation and exploratory cognitive improvements, with no serious adverse events reported.
IGC-AD1's dual-API formulation interacts with CB1 and CB2 receptors and targets neuroinflammation. Preclinical studies demonstrated a 20% reduction in amyloid plaques and 50% improvement in spatial memory. The expansion into Florida aims to improve diversity in trial recruitment through the state's diverse population.
IGC Pharma (NYSE American:IGC) ha ampliato il suo trial di fase 2 CALMA per IGC-AD1, aggiungendo l'ospedale St. Anthony di BayCare a St. Petersburg, Florida, come nuovo sito di sperimentazione. IGC-AD1 è una terapia combinata che mira a trattare l'agitazione nella demenza di Alzheimer, che colpisce fino al 76% dei pazienti.
Il trial sarà guidato dal Dr. Michael A. Franklin, un neurologo certificato presso l'ospedale St. Anthony. L'attuale trial di fase 2, che coinvolge 146 pazienti, ha mostrato risultati preliminari promettenti, inclusi significativi riduzioni dell'agitazione e miglioramenti cognitivi esplorativi, senza eventi avversi gravi riportati.
La formulazione a doppio principio attivo di IGC-AD1 interagisce con i recettori CB1 e CB2 e mira a combattere la neuroinfiammazione. Studi preclinici hanno dimostrato una riduzione del 20% delle placche amiloidi e un miglioramento del 50% nella memoria spaziale. L'espansione in Florida mira a migliorare la diversità nel reclutamento dei partecipanti grazie alla popolazione variegata dello stato.
IGC Pharma (NYSE American:IGC) ha ampliado su ensayo de fase 2 CALMA para IGC-AD1, añadiendo el Hospital St. Anthony de BayCare en St. Petersburg, Florida, como un nuevo sitio de ensayo. IGC-AD1 es una terapia combinada que se dirige a la agitación en la demencia de Alzheimer, que afecta hasta al 76% de los pacientes.
El ensayo será dirigido por el Dr. Michael A. Franklin, un neurólogo certificado en el Hospital St. Anthony. El ensayo de fase 2, que involucra a 146 pacientes, ha mostrado resultados interinos prometedores, incluyendo reducciones significativas en la agitación y mejoras cognitivas exploratorias, sin eventos adversos graves reportados.
La formulación de doble API de IGC-AD1 interactúa con los receptores CB1 y CB2 y se dirige a la neuroinflamación. Los estudios preclínicos demostraron una reducción del 20% en las placas amiloides y una mejora del 50% en la memoria espacial. La expansión en Florida tiene como objetivo mejorar la diversidad en el reclutamiento de ensayos a través de la población diversa del estado.
IGC Pharma (NYSE American:IGC)는 IGC-AD1의 2상 CALMA 시험을 확장하여 플로리다주 세인트피터즈버그에 있는 BayCare의 St. Anthony 병원을 새로운 시험 사이트로 추가했습니다. IGC-AD1은 알츠하이머 치매에서의 불안정을 목표로 하는 복합 요법으로, 환자의 최대 76%에 영향을 미칩니다.
시험은 St. Anthony 병원의 인증된 신경학자인 Dr. Michael A. Franklin가 이끌게 됩니다. 현재 진행 중인 146명의 환자를 대상으로 하는 2상 시험은 불안정성의 유의미한 감소와 탐색적 인지 개선을 포함한 유망한 중간 결과를 보여주었으며, 심각한 부작용은 보고되지 않았습니다.
IGC-AD1의 이중 API 제형은 CB1 및 CB2 수용체와 상호 작용하며 신경 염증을 목표로 합니다. 전임상 연구에서는 아밀로이드 플라크가 20% 감소하고 공간 기억력이 50% 개선되었음을 보여주었습니다. 플로리다로의 확장은 주의 다양한 인구를 통해 시험 모집의 다양성을 향상시키려는 목표를 가지고 있습니다.
IGC Pharma (NYSE American:IGC) a élargi son essai de phase 2 CALMA pour IGC-AD1, en ajoutant l'hôpital St. Anthony de BayCare à St. Petersburg, en Floride, comme nouveau site d'essai. IGC-AD1 est une thérapie combinée ciblant l'agitation dans la démence d'Alzheimer, qui touche jusqu'à 76 % des patients.
L'essai sera dirigé par le Dr. Michael A. Franklin, neurologue certifié à l'hôpital St. Anthony. L'essai de phase 2 en cours, qui implique 146 patients, a montré des résultats intermédiaires prometteurs, y compris des réductions significatives de l'agitation et des améliorations cognitives exploratoires, sans événements indésirables graves signalés.
La formulation à double API d'IGC-AD1 interagit avec les récepteurs CB1 et CB2 et cible la neuroinflammation. Des études précliniques ont démontré une réduction de 20 % des plaques amyloïdes et une amélioration de 50 % de la mémoire spatiale. L'expansion en Floride vise à améliorer la diversité dans le recrutement des participants grâce à la population variée de l'État.
IGC Pharma (NYSE American:IGC) hat seine Phase-2-Studie CALMA für IGC-AD1 erweitert und das St. Anthony's Hospital von BayCare in St. Petersburg, Florida, als neuen Studienstandort hinzugefügt. IGC-AD1 ist eine Kombinationstherapie, die auf die Unruhe bei Alzheimer-Demenz abzielt, die bis zu 76% der Patienten betrifft.
Die Studie wird von Dr. Michael A. Franklin, einem zertifizierten Neurologen am St. Anthony's Hospital, geleitet. Die laufende Phase-2-Studie mit 146 Patienten hat vielversprechende vorläufige Ergebnisse gezeigt, darunter signifikante Reduktionen der Unruhe und explorative kognitive Verbesserungen, ohne dass schwerwiegende Nebenwirkungen berichtet wurden.
Die Dual-API-Formulierung von IGC-AD1 interagiert mit den CB1- und CB2-Rezeptoren und zielt auf Neuroinflammation ab. Präklinische Studien haben eine Reduzierung der Amyloid-Plaques um 20% und eine Verbesserung des räumlichen Gedächtnisses um 50% gezeigt. Die Expansion nach Florida zielt darauf ab, die Vielfalt bei der Rekrutierung von Studienteilnehmern durch die vielfältige Bevölkerung des Bundesstaates zu verbessern.
- Interim results show significant reduction in agitation with no serious adverse events
- Preclinical studies demonstrated 20% reduction in amyloid plaques
- 50% improvement in spatial memory in preclinical studies
- Expansion of trial sites increases patient access and diversity
- None.
Insights
IGC Pharma's expansion of its Phase 2 CALMA trial to include BayCare's St. Anthony's Hospital represents positive operational progress in the company's clinical development program for IGC-AD1. This strategic addition provides several advantages for the ongoing 146-patient study examining the treatment of agitation in Alzheimer's dementia.
The expansion to BayCare, a major health system with 16 hospitals in Florida, potentially offers three key benefits: accelerated patient recruitment, access to Florida's diverse population (addressing the critical issue of representation in clinical trials), and the addition of experienced clinical investigators like Dr. Michael Franklin.
The article references encouraging interim results from the CALMA trial, noting "significant reductions in agitation and exploratory cognitive improvements" with no serious adverse events reported. These preliminary signals are complemented by preclinical findings showing
For context, agitation affects up to
For a company with a
The addition of BayCare's St. Anthony's Hospital to IGC Pharma's CALMA trial represents incremental positive news that strengthens the company's clinical execution capabilities. While not a major catalyst like final trial results or regulatory feedback, this development indicates forward momentum in their clinical program.
From a competitive standpoint, IGC-AD1 targets a specific and substantial unmet need in Alzheimer's treatment. Agitation symptoms affect a significant percentage of patients and create considerable burden, yet few therapies specifically address this aspect of the disease. The dual mechanism targeting both CB1/CB2 receptors and neuroinflammatory pathways, particularly the inflammasome, represents a differentiated approach.
The interim results mentioned warrant investor attention - significant agitation reduction coupled with exploratory cognitive improvements suggests potential for a therapy that could address both symptomatic relief and possibly underlying disease mechanisms. However, these remain preliminary findings that require validation in the complete dataset.
For context, expanding clinical site networks is particularly important for smaller biotechs to maintain recruitment timelines. Adding an established health system like BayCare, with its substantial regional presence, demonstrates effective clinical operations management. This expansion also addresses a important industry challenge - ensuring diverse patient populations in clinical trials - which increasingly matters to regulators and potential commercial partners.
The market opportunity for effective agitation therapies in Alzheimer's is substantial, with approved options despite the prevalence and burden of these symptoms. For IGC Pharma, with its current
POTOMAC, MARYLAND / ACCESS Newswire / March 17, 2025 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC Pharma" or the "Company") today announced the addition of a new trial site at BayCare's St. Anthony's Hospital in St. Petersburg, Florida as part of its ongoing Phase 2 CALMA trial evaluating IGC-AD1, the Company's lead therapeutic candidate, for the treatment of agitation in Alzheimer's dementia.
IGC-AD1 is a combination therapy designed to address agitation in Alzheimer's disease. As a two-API formulation, it interacts with CB1 and CB2 receptors while targeting neuroinflammation, including pathways associated with the inflammasome, which has been implicated in both neurodegeneration and the inflammatory processes that contribute to agitation in Alzheimer's.
The CALMA trial aims to assess the safety and efficacy of IGC-AD1 in addressing this challenging symptom, which affects up to
"We are thrilled to welcome BayCare Health System, St. Anthony's Hospital, and Dr. Franklin to our CALMA clinical trial," said Ram Mukunda, CEO of IGC Pharma. "This addition strengthens our clinical research capabilities and underscores our commitment to improving diversity and inclusion in Alzheimer's trials. Florida's diverse population offers a unique opportunity to recruit underrepresented communities, ensuring that critical advancements in Alzheimer's treatments are accessible to all."
"Our physicians and providers are passionate about finding potential solutions for patients where gaps exist in therapies available today," said Danielle Mauck, BayCare's vice president of research and sponsored programs. "Partnerships on projects like CALMA allow us to support our physicians, providers, and patients with those efforts.
IGC-AD1 is currently being evaluated in a 146-patient Phase 2 trial targeting agitation in Alzheimer's dementia. Interim results have demonstrated significant reductions in agitation and exploratory cognitive improvements, with a strong safety profile and no serious adverse events reported. Additionally, preclinical studies showed that IGC-AD1 reduced amyloid plaques by approximately
About IGC Pharma (dba IGC):
IGC Pharma is an AI-powered, clinical-stage biotechnology company focused on developing innovative treatments for Alzheimer's disease and transforming patient care with fast-acting, safe, and effective solutions. Our portfolio includes the TGR family, including TGR-63, which targets amyloid plaques, a hallmark of Alzheimer's. The IGC-C and IGC-M platforms are advancing in preclinical studies, focusing on metabolic disorders, tau proteins, early plaque formation, and multiple disease hallmarks. Our lead therapeutic candidate, IGC-AD1, is a cannabinoid-based treatment currently in a Phase 2 trial for agitation in dementia ("CALMA") associated with Alzheimer's (clinicaltrials.gov, IGC Pharma Phase II). Interim data for IGC-AD1 demonstrated that it has the potential to transform patient care by offering faster-acting and more effective relief compared to traditional medications. Additionally, our AI models are designed to predict potential biomarkers for the early detection of Alzheimer's, optimize clinical trials, and predict receptor affinity, among others. With 32 patent filings and a commitment to innovation, IGC Pharma is dedicated to advancing pharmaceutical treatments and improving the lives of those affected by Alzheimer's and related conditions. The Company operates a wellness brand offering scientifically formulated products under the brand Holiby™ and as white-labeled formulations.
About St. Anthony's Hospital
St. Anthony's Hospital is a 448-bed hospital founded in 1931 as a ministry of the Franciscan Sisters of Allegany. The hospital has a rich history dedicated to improving the health of the community by providing high-quality, innovative and compassionate care, and recently opened a new patient tower with 90 private rooms. Part of BayCare Health System, St. Anthony's Hospital is located at 1200 Seventh Avenue North in St. Petersburg, Florida. For more information: BayCare.org/SAH.
About BayCare
BayCare is a leading not-for-profit health care system that connects individuals and families to a wide range of services at 16 hospitals and hundreds of other convenient locations throughout the Tampa Bay and central Florida regions. The system is West Central Florida's largest provider of behavioral health and pediatric services and its provider group, BayCare Medical Group, is one of the largest in the region. BayCare's diverse network of ambulatory services includes laboratories, imaging, surgical centers, BayCare Urgent Care locations, wellness centers and one of Florida's largest home care agencies, BayCare HomeCare. BayCare's mission is to improve the health of all it serves through community-owned, health care services that set the standard for high-quality, compassionate care. For more information visit BayChttps://baycare.org/are.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.
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