IGC Pharma Names IGC-AD1 Phase 2 Clinical Trial for Alzheimer's Agitation "CALMA" and Expands Recruitment Strategy
IGC Pharma has officially named its Phase 2 trial for Alzheimer's agitation as CALMA (Calming Agitation in Alzheimer's). The trial addresses agitation, a condition affecting up to 76% of the 55 million Alzheimer's patients worldwide. The company has implemented an innovative recruitment strategy using geofencing technology and digital outreach through social media platforms.
The pilot recruitment campaign at select trial sites achieved a 200-300% increase in enrollment at a relatively low cost per lead. IGC Pharma is now expanding this strategy across all trial locations in the USA and Canada, targeting individuals within a 15-25-mile radius of clinical sites. The company aims to complete enrollment and the CALMA trial in the second half of 2025.
IGC Pharma ha ufficialmente nominato il suo studio di fase 2 per l'agitazione nell'Alzheimer CALMA (Calmare l'Agitazione nell'Alzheimer). Lo studio affronta l'agitazione, una condizione che colpisce fino al 76% dei 55 milioni di pazienti affetti da Alzheimer in tutto il mondo. L'azienda ha implementato una strategia innovativa di reclutamento utilizzando tecnologia geofencing e outreach digitale attraverso le piattaforme dei social media.
La campagna pilota di reclutamento in alcuni siti di prova ha ottenuto un aumento del 200-300% nell'iscrizione a un costo relativamente basso per contatto. IGC Pharma sta ora espandendo questa strategia in tutti i siti di prova negli Stati Uniti e in Canada, mirando a individui all'interno di un raggio di 15-25 miglia dai siti clinici. L'azienda punta a completare l'iscrizione e lo studio CALMA nella seconda metà del 2025.
IGC Pharma ha nombrado oficialmente su ensayo de Fase 2 para la agitación en Alzheimer como CALMA (Calmando la Agitación en Alzheimer). El ensayo aborda la agitación, una condición que afecta hasta al 76% de los 55 millones de pacientes con Alzheimer en todo el mundo. La compañía ha implementado una estrategia de reclutamiento innovadora utilizando tecnología geofencing y divulgación digital a través de plataformas de redes sociales.
La campaña piloto de reclutamiento en sitios de ensayo selectos logró un aumento del 200-300% en la inscripción a un costo relativamente bajo por contacto. IGC Pharma ahora está expandiendo esta estrategia a todos los sitios de ensayo en EE. UU. y Canadá, enfocándose en individuos dentro de un radio de 15-25 millas de los sitios clínicos. La compañía tiene como objetivo completar la inscripción y el ensayo CALMA en la segunda mitad de 2025.
IGC Pharma는 알츠하이머로 인한 동요에 대한 2상 임상을 CALMA (Calming Agitation in Alzheimer's)으로 공식 명명하였습니다. 이 임상은 전 세계 5,500만 알츠하이머 환자의 최대 76%에 영향을 미치는 동요를 다루고 있습니다. 회사는 지오펜싱 기술과 소셜 미디어 플랫폼을 통한 디지털 홍보를 이용하여 혁신적인 모집 전략을 시행하였습니다.
선정된 임상 사이트에서의 파일럿 모집 캠페인은 상대적으로 낮은 비용으로 200-300%의 등록 증가를 달성하였습니다. IGC Pharma는 현재 미국과 캐나다의 모든 임상 사이트로 이 전략을 확대하고 있으며, 임상 사이트로부터 15-25 마일 이내에 있는 개인을 대상으로 하고 있습니다. 회사는 2025년 하반기까지 등록을 완료하고 CALMA 임상을 마치는 것을 목표로 하고 있습니다.
IGC Pharma a officiellement nommé son essai de phase 2 sur l'agitation liée à la maladie d'Alzheimer CALMA (Calmer l'Agitation dans Alzheimer). L'essai aborde l'agitation, une condition affectant jusqu'à 76% des 55 millions de patients Alzheimer dans le monde. L'entreprise a mis en œuvre une stratégie de recrutement innovante en utilisant la technologie de geofencing et une sensibilisation numérique via les plateformes de médias sociaux.
La campagne de recrutement pilote sur certains sites d'essai a obtenu une augmentation de 200 à 300% des inscriptions à un coût relativement bas par contact. IGC Pharma étend maintenant cette stratégie à tous les sites d'essai aux États-Unis et au Canada, ciblant des individus dans un rayon de 15 à 25 miles des sites cliniques. L'entreprise vise à terminer l'inscription et l'essai CALMA au cours de la seconde moitié de 2025.
IGC Pharma hat seinen Phase-2-Test für die Unruhe bei Alzheimer offiziell als CALMA (Beruhigung der Unruhe bei Alzheimer) benannt. Die Studie befasst sich mit Unruhe, einem Zustand, der bis zu 76% der 55 Millionen Alzheimer-Patienten weltweit betrifft. Das Unternehmen hat eine innovative Rekrutierungsstrategie implementiert, die Geofencing-Technologie und digitale Ansprache über soziale Medien nutzt.
Die Pilotkampagne zur Rekrutierung an ausgewählten Teststandorten erzielte einen Anstieg von 200-300% bei der Einschreibung zu relativ niedrigen Kosten pro Interessent. IGC Pharma erweitert diese Strategie nun auf alle Teststandorte in den USA und Kanada und richtet sich an Personen im Umkreis von 15-25 Meilen um die klinischen Standorte. Das Unternehmen plant, die Einschreibung und die CALMA-Studie in der zweiten Hälfte des Jahres 2025 abzuschließen.
- Achieved 200-300% enrollment increase at pilot sites using geofencing technology
- Low cost per lead in recruitment campaign
- Trial addresses large market opportunity (76% of 55 million Alzheimer's patients)
- Clear timeline for trial completion (H2 2025)
- Trial completion not expected until second half of 2025
- Still in recruitment phase for Phase 2 trial
Insights
The CALMA trial's enhanced recruitment strategy marks a significant operational advancement in IGC Pharma's Phase 2 clinical trial. The 200-300% increase in enrollment through geofencing technology demonstrates remarkable efficiency in patient recruitment - a critical bottleneck in Alzheimer's trials where recruitment typically accounts for 30% of clinical study timelines.
Targeting a 15-25 mile radius around clinical sites is particularly strategic, as it balances accessibility with the practical limitations of trial participation. This geographic precision, combined with digital outreach, could significantly reduce the typical patient recruitment timeline of 18-24 months for Alzheimer's trials. The emphasis on including underserved communities also aligns with FDA's growing focus on trial diversity, potentially strengthening the eventual regulatory submission.
The projected completion in H2 2025 appears feasible given the recruitment acceleration, though investors should note that Phase 2 trials in Alzheimer's typically have a 10.5-month treatment duration. The target indication of agitation in Alzheimer's represents a substantial market opportunity, affecting up to 76% of 55 million global patients, with current treatment options.
The trial's rebranding as CALMA and improved recruitment strategy significantly enhance IGC Pharma's market positioning. The cost-effective digital recruitment approach is particularly noteworthy for a micro-cap company with a market cap of
IGC's focus on Alzheimer's agitation targets an underserved market segment. Current treatments are , creating a substantial commercial opportunity if IGC-AD1 proves successful. The global Alzheimer's therapeutics market, valued at
The strategic emphasis on digital outreach and community engagement could potentially reduce the typical per-patient recruitment cost of
Innovative use of geofencing technology boosts enrollment at select sites
POTOMAC, MD / ACCESSWIRE / January 8, 2025 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC Pharma" or the "Company") announced today that its ongoing Phase 2 trial for agitation in Alzheimer's disease has been officially named CALMA (Calming Agitation in Alzheimer's).
The trial's new identity reflects its mission to address agitation, a syndrome affecting up to
To accelerate enrollment across all clinical sites, IGC Pharma has implemented an innovative recruitment campaign leveraging geofencing technology and digital outreach through social media platforms. The recruitment strategy was piloted at select trial sites, where it achieved a remarkable 200
By combining advanced outreach tools with CALMA's clear focus, IGC aims to enhance engagement with patients and caregivers while advancing toward key milestones in Alzheimer's treatment development.
Ram Mukunda, CEO of IGC Pharma, commented, "Recruitment is one of the most significant challenges in Alzheimer's clinical trials, and our use of innovative geofencing technology, wherein we digitally target individuals living in a 15-25-mile radius of a clinical site, has delivered impressive results, achieving a significant outreach and enrollment at select sites. Scaling this strategy across all trial locations, in the USA and Canada, we expect will accelerate our progress toward completing the CALMA trial and strengthen our ability to engage with patients and caregivers. The strategy is especially powerful in recruiting members of underserved communities. By leveraging advanced digital outreach tools, we aim to enhance trial awareness, streamline recruitment, and advance IGC-AD1's development as a transformative therapy for Alzheimer's agitation. This milestone represents another step forward in creating value for both patients and our shareholders."
About CALMA
The CALMA trial is a multicenter, double-blind, randomized, placebo-controlled Phase 2 study involving 164 participants. It is designed to evaluate the safety and efficacy of IGC-AD1, a partial CB1 receptor agonist with anti-neuroinflammatory properties, in treating agitation - a syndrome that accelerates cognitive decline and increases hospitalization rates among Alzheimer's patients.
Individuals can learn more about the Calma trial here: Facebook page
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 associated with Alzheimer's (clinicaltrials.gov, NCT05543681). 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 28 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.
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-Q filed with the SEC on August 7, 2024, 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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FAQ
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