IGC Pharma Expands Phase 2 CALMA Clinical Trial to University of South Florida's Department of Psychiatry and Behavioral Neurosciences
IGC Pharma (NYSE American:IGC) announced expansion of its Phase 2 CALMA trial of investigational IGC-AD1 for agitation in Alzheimer's disease with a new clinical site at the University of South Florida Department of Psychiatry and Behavioral Neurosciences effective October 14, 2025.
Enrollment at the USF site has begun with four participants already enrolled. CALMA is a randomized, double-blind, placebo-controlled Phase 2 study evaluating the efficacy and safety of IGC-AD1; the company says the USF site will help accelerate recruitment and diversify participants as the trial continues to expand across North America.
IGC Pharma (NYSE American:IGC) annuncia l'espansione della sua fase 2 CALMA trial di investigational IGC-AD1 per l'agitazione nella malattia di Alzheimer con una nuova sede clinica presso il Dipartimento di Psichiatria e Neuroscienze Comportamentali dell'Università della Florida del Sud, effettiva dal 14 ottobre 2025.
L'arruolamento presso la sede USF è iniziato con quattro partecipanti già arruolati. CALMA è uno studio di fase 2 randomizzato, in doppio cieco e controllato con placebo che valuta l'efficacia e la sicurezza di IGC-AD1; l'azienda afferma che la sede USF contribuirà ad accelerare il reclutamento e a diversificare i partecipanti man mano che lo studio si espande in Nord America.
IGC Pharma (NYSE American:IGC) anunció la expansión de su ensayo de Fase 2 CALMA de IGC-AD1 para la agitación en la enfermedad de Alzheimer con una nueva sede clínica en el Departamento de Psiquiatría y Neurociencias Conductuales de la Universidad del Sur de Florida, vigente a partir del 14 de octubre de 2025.
El reclutamiento en la sede de USF ha comenzado con cuatro participantes ya inscritos. CALMA es un estudio de fase 2 aleatorizado, doble ciego, controlado con placebo que evalúa la eficacia y seguridad de IGC-AD1; la empresa dice que la sede de USF ayudará a acelerar el reclutamiento y a diversificar a los participantes a medida que el ensayo continúa expandiéndose por Norteamérica.
IGC Pharma (NYSE American:IGC)는 알츠하이머 병의 동요를 위한 연구 대상 IGC-AD1의 2상 CALMA 시험 확장을 2025년 10월 14일부터 효력 있는 사우스플로리다 대학 정신의학 및 행동신경과학부의 새로운 임상 사이트로 발표했습니다.
USF 사이트에서의 등록은 이미 네 명의 참여자가 등록되어 시작되었습니다. CALMA는 무작위, 이중 맹검, 위약 대조 2상 연구로 IGC-AD1의 유효성 및 안전성을 평가합니다; 회사는 USF 사이트가 북미 전역으로 시험이 확장됨에 따라 모집을 가속화하고 참가자를 다양화하는 데 도움이 될 것이라고 말합니다.
IGC Pharma (NYSE American:IGC) a annoncé l'extension de son essai de phase 2 CALMA d'IGC-AD1 pour l'agitation dans la maladie d'Alzheimer, avec un nouveau site clinique au Department of Psychiatry and Behavioral Neurosciences de l'Université de South Florida, à compter du 14 octobre 2025.
Le recrutement sur le site USF a commencé avec quatre participants déjà enrôlés. CALMA est une étude de phase 2 randomisée, en double aveugle et contrôlée par placebo évaluant l'efficacité et la sécurité de IGC-AD1; la société affirme que le site USF aidera à accélérer le recrutement et à diversifier les participants à mesure que l'essai s'étend en Amérique du Nord.
IGC Pharma (NYSE American:IGC) kündigte die Erweiterung seiner Phase-2-Studie CALMA mit IGC-AD1 zur agitation bei Alzheimer-Krankheit an, mit einer neuen klinischen Studienstelle am Department of Psychiatry and Behavioral Neurosciences der University of South Florida, gültig ab dem 14. Oktober 2025.
Die Rekrutierung an der USF-Stelle hat mit vier bereits eingeschriebenen Teilnehmern begonnen. CALMA ist eine randomisierte, doppelblinde, placebokontrollierte Phase-2-Studie, die die Wirksamkeit und Sicherheit von IGC-AD1 bewertet; das Unternehmen sagt, die USF-Stelle werde dazu beitragen, die Rekrutierung zu beschleunigen und Teilnehmer zu diversifizieren, während die Studie weiter in Nordamerika expandiert.
IGC Pharma (NYSE American:IGC) أعلنت عن توسيع تجربة المرحلة 2 CALMA لدواء IGC-AD1 للاستياء في مرض الزهايمر مع موقع سريري جديد في قسم الطب النفسي وعلوم الأعصاب السلوكية بجامعة جنوب فلويد اعتباراً من 14 أكتوبر 2025.
بدأ التسجيل في موقع USF مع أربعة مشاركين مسجلين بالفعل. CALMA هي دراسة من المرحلة 2 عشوائية مزدوجة التعمية وخاضعة لعلاج وهمي تقيم فاعلية وسلامة IGC-AD1؛ وتقول الشركة إن الموقع في USF سيساعد على تسريع التوظيف وتنويع المشاركين مع استمرار التجربة في الانتشار عبر أمريكا الشمالية.
IGC Pharma (NYSE American:IGC)宣布扩大其2期 CALMA 试验，针对阿尔茨海默病的躁动，研究药物 IGC-AD1，新增临床点位于南佛罗里达大学精神病学与行为神经科学系，自2025年10月14日起生效。
USF点位的招募已开始，已招募四名参与者。CALMA 是一项随机、双盲、安慰剂对照的2期研究，评估 IGC-AD1 的有效性和安全性；公司表示，USF 点位将帮助加快招募并在试验继续在北美扩展的同时，提升参与者的多样性。
- New site opened at University of South Florida
- 4 participants enrolled at the USF site
- CALMA remains randomized, double-blind, placebo-controlled
- Enrollment still early: only 4 participants at new site
- No efficacy or safety readouts reported in this announcement
Insights
IGC Pharma added a new Phase 2 CALMA site at the University of South Florida and has enrolled four participants, modestly accelerating recruitment.
IGC Pharma expands the randomized, double-blind, placebo-controlled CALMA trial by opening a new site led by Dr. Ram Bishnoi at the University of South Florida. The immediate effect is incremental recruitment capacity and added clinical oversight for the study of IGC-AD1 in agitation associated with Alzheimer’s disease; enrollment at the new site has already begun with four participants.
Key dependencies and risks include site-level enrollment rates, protocol adherence, and data quality; none of these are resolved simply by opening a site. The announcement contains no efficacy or safety data, so clinical or regulatory impact remains unmeasured. Operational risks such as slower-than-expected recruitment or protocol deviations could blunt the stated momentum.
Concrete items to watch are cumulative enrollment across all CALMA sites, any disclosed interim safety or efficacy updates, and site activation timelines. Expect relevant updates as enrollment milestones are reported and when the trial releases prospective interim analyses or topline results (monitor over the coming quarters to see whether this site materially shortens overall recruitment timelines).
POTOMAC, MD, 1734 / ACCESS Newswire / October 14, 2025 / IGC Pharma, Inc. ("IGC Pharma," "IGC," or the "Company") (NYSE American:IGC), a clinical-stage biotechnology company leveraging AI to develop innovative treatments for Alzheimer's disease, today announced the expansion of its ongoing Phase 2 CALMA clinical trial evaluating investigational drug candidate IGC-AD1 for agitation in Alzheimer's disease. The trial has officially opened a new site at the University of South Florida's Department of Psychiatry and Behavioral Neurosciences, under the leadership of Principal Investigator Dr. Ram Bishnoi.
Enrollment at the new site has already begun, with four participants enrolled, marking an important step toward accelerating recruitment and advancing the timeline of the study. The addition of USF, a leading research and academic institution, underscores IGC Pharma's commitment to partnering with distinguished investigators to address the urgent, unmet needs of patients living with Alzheimer's disease.
"The opening of this site at the University of South Florida strengthens our ability to recruit diverse participants while ensuring the highest standard of clinical oversight," said Ram Mukunda, CEO of IGC Pharma. "USF brings a strong academic pedigree, deep expertise in behavioral neuroscience, and an established record in clinical research. With enrollment already underway, we're pleased to see continued momentum in advancing the CALMA trial."
The CALMA Phase 2 trial is a randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of IGC-AD1 in reducing agitation in patients with Alzheimer's disease. With the addition of USF, CALMA continues to expand across multiple clinical sites in North America.
About the University of South Florida Department of Psychiatry and Behavioral Neurosciences
The Department of Psychiatry and Behavioral Neurosciences at the University of South Florida Morsani College of Medicine is a leading academic and clinical institution dedicated to improving mental health through an integrated mission of clinical care, education, and research. Founded in 1971 as USF's first residency training program, the department has achieved national and international recognition for its innovative approaches to treating mental, addictive, and behavioral disorders.
The department engages deeply with the local community through compassionate patient services including outpatient psychiatry, neurotherapies such as TMS and ECT, memory disorder clinics, and child development initiatives while also providing trainees with access to cutting-edge clinical trials and fellowships in key subspecialties.
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 more than 30 patent filings, 12 patents granted 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.
View the original press release on ACCESS Newswire
FAQ
What did IGC announce about the CALMA Phase 2 trial on October 14, 2025?
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What is the design of the CALMA Phase 2 trial for IGC-AD1?
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Where is the new CALMA clinical site located for IGC-AD1?
