IGC Pharma Announces Preclinical Data Demonstrating TGR-63’s Dual Action on Alzheimer’s Pathology
IGC Pharma (NYSE American:IGC) has announced promising preclinical data for its Alzheimer's disease candidate TGR-63. The research reveals TGR-63's dual mechanism of action, demonstrating its ability to target both beta-amyloid (Aβ) plaques and tau protein aggregation, two major hallmarks of Alzheimer's disease.
The studies showed that TGR-63 suppresses tau fibril formation at micromolar concentrations and maintains structural stability under physiological conditions. MALDI mass spectrometry detected the compound in serum samples at both 1- and 24-hours post-administration, indicating strong pharmacological resilience and systemic delivery potential.
IGC Pharma (NYSE American:IGC) ha annunciato dati preclinici promettenti per il suo candidato farmaco per l'Alzheimer TGR-63. La ricerca evidenzia il meccanismo d'azione doppio di TGR-63, dimostrandone la capacità di mirare sia alle placche beta-amyloid (Aβ) sia all'aggregazione della proteina tau, due dei principali segni distintivi della malattia di Alzheimer.
Gli studi hanno mostrato che TGR-63 inibisce la formazione di fibrille tau a concentrazioni micromolari e mantiene la stabilità strutturale in condizioni fisiologiche. La spettrometria di massa MALDI ha rilevato il composto nei campioni di siero sia a 1 sia a 24 ore dalla somministrazione, indicando una forte resilienza farmacologica e un potenziale di somministrazione sistemica.
IGC Pharma (NYSE American:IGC) ha anunciado datos preclínicos prometedores para su candidato a Alzheimer, TGR-63. La investigación revela el doble mecanismo de acción de TGR-63, demostrando su capacidad para dirigirse tanto a placas beta-amiloides (Aβ) como a la agregación de la proteína tau, dos rasgos distintivos de la enfermedad de Alzheimer.
Los estudios mostraron que TGR-63 inhibe la formación de fibras de tau a concentraciones micromolares y mantiene la estabilidad estructural en condiciones fisiológicas. La espectrometría de masas MALDI detectó el compuesto en muestras de suero tanto a 1 como a 24 horas después de la administración, lo que indica una fuerte resiliencia farmacológica y un potencial de entrega sistémica.
IGC Pharma(NYSE American: IGC)은 알츠하이머병 후보 약물인 TGR-63에 대한 유망한 전임상 데이터를 발표했습니다. 연구는 TGR-63의 이중 작용 기전을 보여주며 베타 아밀로이드(Aβ) 플라크와 타우 단백질 응집 두 가지 주요 특징을 함께 표적으로 삼을 수 있음을 시사합니다.
연구에 따르면 TGR-63은 마이크로몰 농도에서 타우 섬유 형성을 억제하고 생리학적 조건에서 구조적 안정성을 유지합니다. MALDI 질량분석은 투여 1시간 및 24시간 후 혈청 샘플에서 화합물을 검출했으며, 이는 강한 약리적 회복력과 체계적 전달 잠재성을 시사합니다.
IGC Pharma (NYSE American:IGC) a annoncé des données précliniques prometteuses pour son candidat au traitement de la maladie d'Alzheimer, le TGR-63. La recherche révèle le double mécanisme d'action de TGR-63, démontrant sa capacité à cibler à la fois les placques beta-amyloïdes (Aβ) et l'agrégation de la protéine tau, deux caractéristiques majeures de la maladie.
Les études ont montré que TGR-63 réprime la formation de fibrilles tau à des concentrations micromolaires et maintient une stabilité structurelle dans des conditions physiologiques. La spectrométrie de masse MALDI a détecté le composé dans des échantillons de sérum à 1 et 24 heures après l’administration, indiquant une forte résilience pharmacologique et un potentiel de délivrance systémique.
IGC Pharma (NYSE American:IGC) hat vielversprechende präklinische Daten für seinen Alzheimer-Kandidaten TGR-63 bekannt gegeben. Die Forschung zeigt den doppelten Wirkmechanismus von TGR-63 und demonstriert seine Fähigkeit, sowohl Beta-Amyloid-Plaques (Aβ) als auch Tau-Protein-Aggregation anzugehen, zwei der Hauptkennzeichen von Alzheimer.
Die Studien zeigten, dass TGR-63 Tau-Fibrillenbildung bei mikromolaren Konzentrationen hemmt und unter physiologischen Bedingungen strukturelle Stabilität bewahrt. MALDI-Massenspektrometrie tat das Verbindung in Serumproben sowohl 1 als auch 24 Stunden nach Verabreichung nach, was auf eine starke pharmakologische Robustheit und ein Potential für systemische Verabreichung hindeutet.
أعلنت شركة IGC Pharma (بورصة NYSE الأمريكية: IGC) عن بيانات preclinical واعدة لمرشحها لعلاج مرض الزهايمر TGR-63. تُظهر الأبحاث آلية عمله المزدوجة، حيث يظهر قدرته على استهداف كل من لوحات بيتا-أميلويد (Aβ) وتجميع بروتين TAU، وهما علامتان رئيسيتان لمرض الزهايمر.
أظهرت الدراسات أن TGR-63 يُثبط تكوين ألياف TAU عند تركيزات ميكرو مولارية ويحافظ على الاستقرار البنيوي في ظروف فسيولوجية. كشفت مطياف الكتلة MALDI عن المركب في عينات المصل عند 1 و24 ساعة بعد الإدارة، مما يشير إلى مقاومة دوائية قوية وإمكانية التوصيل الجهازي.
IGC Pharma（纽约证券交易所：IGC）宣布其阿尔茨海默病候选药物 TGR-63 的前临床数据乐观。研究揭示了 TGR-63 的双重作用机理，能够同时靶向 β淀粉样斑块（Aβ）和 tau 蛋白聚集，这是阿尔茨海默病的两个主要病理标志。
研究显示 TGR-63 在微摩尔浓度下 抑制 tau 蛾化形成，并在生理条件下保持结构稳定性。MALDI 质谱在给药后 1 小时和 24 小时的血清样本中检测到该化合物，表明其具备强健的药理学稳定性和系统给药潜力。
- TGR-63 demonstrates dual mechanism targeting both beta-amyloid and tau protein aggregation
- Compound shows stability in physiological conditions and serum samples
- Technology is protected under IGC Pharma's patent portfolio
- Potential for development as a disease-modifying treatment beyond current single-target therapies
- Still in early preclinical stage with no human trial data
- Effectiveness in actual disease treatment yet to be proven
- Long development pathway ahead before potential commercialization
Insights
IGC's TGR-63 shows promising dual-target mechanism against Alzheimer's pathology in early preclinical testing, but remains years from clinical proof.
The preclinical data for TGR-63 represents a potentially significant scientific development in the Alzheimer's treatment landscape. What makes this compound noteworthy is its dual-targeting mechanism against both beta-amyloid plaques and tau protein aggregation - the two primary pathological hallmarks of Alzheimer's disease.
The data shows that TGR-63 suppresses tau fibril formation at micromolar concentrations, which complements its previously demonstrated ability to disrupt amyloid plaque formation. This dual action is mechanistically compelling since most current therapeutic approaches target only one of these pathologies.
The serum stability studies provide important pharmacokinetic insights, demonstrating that TGR-63 maintains structural integrity in physiological conditions. Detection of the compound via MALDI mass spectrometry at both 1-hour and 24-hour timepoints suggests reasonable pharmacological persistence, which is crucial for therapeutic efficacy.
However, several critical factors must be considered. These findings are still at the preclinical stage - far removed from human clinical trials. The micromolar concentrations required for tau inhibition suggest moderate potency at best; nanomolar potency would be more desirable for clinical applications. Additionally, while dual targeting is theoretically advantageous, it remains unproven whether this approach will translate to clinical benefits, especially considering recent disappointments with amyloid-targeting therapies.
This represents an incremental scientific advance that positions TGR-63 as a differentiated asset in IGC's pipeline, but substantial development hurdles remain before any conclusions about therapeutic potential can be drawn.
POTOMAC, MD / ACCESS Newswire / September 24, 2025 / IGC Pharma, Inc. (NYSE American:IGC) today announced preclinical findings on TGR-63, the Company's investigational small-molecule candidate for Alzheimer's disease. The data demonstrate that TGR-63 extends its therapeutic potential beyond previously reported effects on beta-amyloid (Aβ) pathology by also inhibiting tau protein aggregation, another key hallmark of Alzheimer's.
"These results underscore the potential of TGR-63 as a differentiated, dual-acting candidate that targets both beta-amyloid and tau, two central drivers of Alzheimer's pathology," said Ram Mukunda, CEO of IGC Pharma. "By broadening our portfolio with this important addition, we are strengthening IGC's capabilities in developing safer and more effective therapies that go beyond the limitations of current treatments. We are continuing to advance the preclinical evaluation of TGR-63 as we work toward building a pipeline of truly disease-modifying solutions for Alzheimer's."
In in vitro assays, TGR-63 was shown to suppress tau fibril formation at micromolar concentrations, suggesting its ability to interfere with the development of neurofibrillary tangles strongly associated with neuronal dysfunction and cognitive decline. This activity complements prior findings that TGR-63 effectively disrupts Aβ plaque aggregation.
Additionally, serum stability studies confirmed that TGR-63 retains its structural integrity under physiological conditions. The compound remained stable when incubated in phosphate-buffered saline (PBS) and mouse blood serum at 37 °C for several hours.
Complementary MALDI mass spectrometry further detected TGR-63 in serum samples at both 1- and 24-hours post-administration, supporting its pharmacological resilience and systemic delivery potential.
These encouraging findings validate TGR-63's dual mechanism of action, which is protected under IGC Pharma's patent portfolio. Building on this foundation, the Company is well-positioned to advance TGR-63 through continued preclinical development with the goal of establishing a novel, disease-modifying approach to Alzheimer's that is distinct from current single-target therapies.
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 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.
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