IGC Pharma Announces Additional Data Supporting IGC-AD1 as an Alzheimer's Treatment
IGC Pharma (NYSE American: IGC) has announced promising preclinical data for IGC-AD1, its potential Alzheimer's disease treatment. The drug demonstrates the ability to modify tau pathology and improve spatial memory, building on previous findings of amyloid plaque reduction. Key results include:
1. 10% reduction in the ratio of phosphorylated tau to total tau
2. 35% reduction in GSK3 enzyme expression
3. 50% faster improvement in spatial memory tests
IGC-AD1 is currently in a Phase 2 clinical trial for agitation in Alzheimer's, with over 1,000 oral doses administered and no dose-limiting adverse events observed. The company aims to position IGC-AD1 for two large indications: agitation in Alzheimer's and as a disease-modifying anti-amyloid/anti-tangle treatment.
IGC Pharma (NYSE American: IGC) ha annunciato dati preclinici promettenti per IGC-AD1, il suo potenziale trattamento per la malattia di Alzheimer. Il farmaco dimostra la capacità di modificare la patologia tau e migliorare la memoria spaziale, basandosi sui risultati precedenti di riduzione delle placche di amiloide. I risultati chiave includono:
1. Riduzione del 10% nel rapporto di tau fosforilato rispetto al tau totale
2. Riduzione del 35% nell'espressione dell'enzima GSK3
3. Miglioramento del 50% più veloce nei test di memoria spaziale
IGC-AD1 è attualmente in fase 2 di sperimentazione clinica per l'agitazione nell'Alzheimer, con oltre 1.000 dosi orali somministrate e nessun evento avverso limitante la dose osservato. L'azienda mira a posizionare IGC-AD1 per due grandi indicazioni: agitazione nell'Alzheimer e come trattamento modificante la malattia anti-amiloide/anti-tangle.
IGC Pharma (NYSE American: IGC) ha anunciado datos preclínicos prometedores para IGC-AD1, su potencial tratamiento para la enfermedad de Alzheimer. El medicamento demuestra la capacidad de modificar la patología tau y mejorar la memoria espacial, apoyándose en hallazgos previos sobre la reducción de placas de amiloide. Los resultados clave incluyen:
1. Reducción del 10% en la relación de tau fosforilado a tau total
2. Reducción del 35% en la expresión de la enzima GSK3
3. Mejora un 50% más rápida en pruebas de memoria espacial
IGC-AD1 se encuentra actualmente en un ensayo clínico de fase 2 para la agitación en el Alzheimer, con más de 1,000 dosis orales administradas y sin eventos adversos limitantes de dosis observados. La empresa tiene como objetivo posicionar IGC-AD1 para dos grandes indicaciones: agitación en Alzheimer y como tratamiento modificador de la enfermedad anti-amiloide/anti-enredo.
IGC Pharma (NYSE American: IGC)는 IGC-AD1에 대한 유망한 전임상 데이터를 발표했습니다. 이는 알츠하이머병 치료제로서의 가능성을 지니고 있습니다. 이 약물은 타우 병리학을 수정하고 공간 기억을 향상시키는 능력을 보여주며, 아밀로이드 플라크 감소에 대한 이전의 발견을 바탕으로 하고 있습니다. 주요 결과는 다음과 같습니다:
1. 10% 감소된 인산화 타우와 총 타우의 비율
2. 35% 감소된 GSK3 효소 발현
3. 50% 더 빠른 개선을 보인 공간 기억 테스트
IGC-AD1은 현재 알츠하이머의 동요를 위한 2상 임상 시험 중이며, 1,000회 이상의 경구 투여가 이루어졌고, 용량 제한적인 부작용은 관찰되지 않았습니다. 회사는 IGC-AD1을 알츠하이머의 동요와 질병 수정형 항 아밀로이드/항 타 엔치 치료를 포함한 두 가지 주요 적응증으로 자리 매김할 계획입니다.
IGC Pharma (NYSE American: IGC) a annoncé des données précliniques prometteuses pour IGC-AD1, son potentiel traitement de la maladie d'Alzheimer. Le médicament démontre la capacité de modifier la pathologie tau et d'améliorer la mémoire spatiale, s'appuyant sur des découvertes antérieures de réduction des plaques amyloïdes. Les résultats clés comprennent :
1. Réduction de 10% du ratio tau phosphorylé au tau total
2. Réduction de 35% de l'expression de l'enzyme GSK3
3. Amélioration 50% plus rapide dans les tests de mémoire spatiale
IGC-AD1 est actuellement en essai clinique de phase 2 pour l'agitation dans la maladie d'Alzheimer, avec plus de 1 000 doses orales administrées et aucun événement indésirable limitant la dose observé. L'entreprise vise à positionner IGC-AD1 pour deux grandes indications : l'agitation dans la maladie d'Alzheimer et comme traitement modificateur de la maladie anti-amyloïde/anti-enchevêtrement.
IGC Pharma (NYSE American: IGC) hat vielversprechende präklinische Daten für IGC-AD1 bekannt gegeben, eine potenzielle Therapie gegen Alzheimer. Das Medikament zeigt die Fähigkeit, die Tau-Pathologie zu modifizieren und räumliches Gedächtnis zu verbessern, basierend auf vorherigen Ergebnissen zur Reduktion von Amyloid-Plaques. Die wichtigsten Ergebnisse sind:
1. 10% Reduktion im Verhältnis von phosphoryliertem Tau zu totalem Tau
2. 35% Reduktion der GSK3-Enzymexpression
3. 50% schnellere Verbesserung bei Tests zum räumlichen Gedächtnis
IGC-AD1 befindet sich derzeit in einer Phase 2 klinischen Studie zur Agitation bei Alzheimer, mit über 1.000 verabreichten oralen Dosen und keinen dosislimitierenden Nebenwirkungen. Das Unternehmen hat das Ziel, IGC-AD1 für zwei große Indikationen zu positionieren: Agitation bei Alzheimer und als krankheitsmodifizierende Anti-Amyloid/Anti-Tangle Therapie.
- Preclinical data shows IGC-AD1 reduces tau hyperphosphorylation by 10%
- IGC-AD1 decreases GSK3 enzyme expression by 35%, potentially mitigating tau tangles
- Spatial memory tests show 50% faster improvement in mice treated with IGC-AD1
- Phase 2 clinical trial for agitation in Alzheimer's is ongoing with over 1,000 doses administered
- No dose-limiting adverse events observed in clinical trials, indicating a good safety profile
- IGC-AD1 is still in early clinical stages, with no proven efficacy in humans yet
- Preclinical results may not translate to human trials
- Competition in the Alzheimer's treatment market is intense
Insights
This news is highly impactful for IGC Pharma. The preclinical data for IGC-AD1 shows promising results in addressing two key pathological hallmarks of Alzheimer's disease: tau tangles and amyloid plaques. The
The spatial memory improvements observed in the Morris Water Maze tests, with IGC-AD1-treated mice showing
This news could significantly impact IGC Pharma's market position and valuation. The potential for IGC-AD1 to target both amyloid plaques and tau pathology positions it uniquely in the competitive Alzheimer's treatment landscape. If successful, IGC-AD1 could capture substantial market share in two large indications: agitation in Alzheimer's and as a disease-modifying treatment. The global Alzheimer's drug market is projected to reach
Investors should note that while preclinical results are promising, clinical trials are still ongoing. The Phase 2 trial results will be important in determining IGC-AD1's future prospects. Positive outcomes could lead to significant value creation for shareholders, potentially through partnerships, licensing deals, or increased market capitalization. However, the high failure rate in Alzheimer's drug development necessitates cautious optimism.
IGC-AD1 demonstrates the potential to modify tau and improve spatial memory
Data supports the initiation of clinical trials investigating IGC-AD1 as a treatment for Alzheimer's disease
IGC Pharma's findings from preclinical Alzheimer's cell line studies have revealed IGC-AD1's significant impact on tau pathology. The data shows that IGC-AD1 effectively reduced hyperphosphorylation of tau protein, a process strongly associated with the formation of neurofibrillary tangles ("NFT" s), which are linked to cognitive decline. Notably, the combined active pharmaceutical ingredients ("API" s) in IGC-AD1 decreased the ratio of phosphorylated tau to total tau by approximately
In addition, data also shows significant improvements in spatial memory from studies using an Alzheimer's mouse model. The Morris Water Maze ("MWM") tests revealed that mice treated with IGC-AD1 exhibited a
Tau tangles are twisted fibers inside neurons, the brain cells responsible for thinking and memory. In Alzheimer's disease, these tangles cause neurons to die, leading to memory loss and cognitive decline. Along with amyloid plaques, tau tangles are one of the key markers of Alzheimer's, contributing to the progression of the disease.
Ram Mukunda, CEO of IGC Pharma, stated, "The formulation not only targets amyloid plaques, as previously disclosed but may also effectively target tau pathology and improve cognitive function. This positions IGC-AD1 uniquely in the Alzheimer's treatment landscape, with the potential to serve both as a disease-modifying drug and a therapy for specific symptoms like agitation in Alzheimer's.
We hope to position the drug for two large indications: 1) agitation in Alzheimer's and 2) as a disease-modifying anti-amyloid / anti-tangles Alzheimer's treatment. These findings open a significant market opportunity for IGC Pharma, potentially driving substantial value for both patients and shareholders."
IGC-AD1 is currently in a Phase 2 clinical trial that is a multicenter, double-blind, randomized, placebo-controlled study designed to assess the safety and efficacy of IGC-AD1 in treating agitation in dementia due to Alzheimer's. Over 1,000 oral doses have been administered to date, with no dose-limiting adverse events observed, highlighting the safety profile of IGC-AD1. As the Company progresses IGC-AD1 into additional clinical trials, the potential to decrease symptoms such as agitation while also modifying Alzheimer's disease progression could significantly enhance its value proposition in the market.
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
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IMS Investor Relations
Rosalyn Christian / Walter Frank
igc@imsinvestorrelations.com
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Source: IGC Pharma, Inc.
FAQ
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