IGC Pharma's Preclinical Data for IGC-1C: New Drug Candidate Potentially Disrupts a Foundational Mechanism of Alzheimer's Disease
IGC (NYSE American: IGC) announced preclinical in-vitro data for IGC-1C on October 7, 2025, describing a novel approach that targets tau protein liquid-liquid phase separation (LLPS).
Key findings include inhibition and dissolution of zinc-mediated tau condensates, reduction in condensate size and number, prevention of conversion to amyloid fibrils, and a measured tau binding affinity of Kd 3.95 ± 0.32 μM. IGC-1C was permeable and well tolerated in SH-SY5Y cell cultures. The company plans additional animal validation studies with the stated goal of advancing IGC-1C toward clinical trials.
IGC (NYSE American: IGC) ha annunciato dati preclinici in vitro per IGC-1C il 7 ottobre 2025, descrivendo un nuovo approccio che mira alla proteina tau mediante la separazione liquido-liquido delle fasi (LLPS).
Tra i principali risultati vi sono l'inibizione e la dissoluzione dei condensati tau mediati dallo zinco, la riduzione delle dimensioni e del numero dei condensati, la prevenzione della loro conversione in fibrille amiloidi e una affinità di legame al tau misurata di Kd 3,95 ± 0,32 μM. IGC-1C è stato permeabile e ben tollerato nelle colture cellulari SH-SY5Y. L'azienda prevede ulteriori studi di convalida animale con l'obiettivo dichiarato di portare IGC-1C alle prove cliniche.
IGC (NYSE American: IGC) anunció datos preclínicos in vitro para IGC-1C el 7 de octubre de 2025, describiendo un enfoque novedoso que apunta a la proteína tau mediante la separación de fases líquido-líquido (LLPS).
Entre los hallazgos clave se encuentran la inhibición y disolución de condensados tau mediados por zinc, la reducción del tamaño y del número de condensados, la prevención de la conversión a fibrillas amiloides, y una afinidad de unión al tau medida de Kd 3,95 ± 0,32 μM. IGC-1C fue permeable y tolerada adecuadamente en cultivos celulares SH-SY5Y. La empresa planea estudios adicionales de validación en animales con el objetivo declarado de avanzar IGC-1C hacia ensayos clínicos.
IGC (NYSE American: IGC)는 2025년 10월 7일 IGC-1C에 대한 인비트로(preclinical in vitro) 데이터를 발표하며 tau 단백질의 액-액 상전이(LLPS)를 겨냥한 새로운 접근법을 설명했습니다.
주요 결과로는 아연에 의해 매개되는 tau 응집체의 억제 및 용해, 응집체의 크기와 수의 감소, 아밀로이드 섬유로의 전환 방지, Kd 3.95 ± 0.32 μM의 tau 결합 친화도가 포함됩니다. IGC-1C는 SH-SY5Y 세포 배양에서 투과성이 있으며 내약성이 양호했습니다. 회사는 IGC-1C를 임상시험으로 진행하기 위한 목표를 가지고 동물 검증 연구를 추가로 계획하고 있습니다.
IGC (NYSE American : IGC) a annoncé des données précliniques in vitro pour IGC-1C le 7 octobre 2025, décrivant une approche nouvelle qui vise la protéine tau par la séparation de phase liquide-liquide (LLPS).
Parmi les résultats clés figurent l'inhibition et la dissolution des condensats tau médiés par le zinc, la réduction de la taille et du nombre des condensats, la prévention de leur conversion en fibrilles amyloïdes, et une affinité de liaison au tau mesurée de Kd 3,95 ± 0,32 μM. IGC-1C était perméable et bien toléré dans les cultures cellulaires SH-SY5Y. L'entreprise prévoit des études supplémentaires de validation animale dans l'objectif déclaré de faire progresser IGC-1C vers des essais cliniques.
IGC (NYSE American: IGC) gab am 7. Oktober 2025 in vitro-Präklinikdaten für IGC-1C bekannt, die einen neuartigen Ansatz beschreiben, der das Tau-Protein durch liquid-liquid Phasen-Separation (LLPS) angreift.
Zu den wichtigsten Ergebnissen gehören die Hemmung und Auflösung von zinkvermittelten Tau-Kon-densaten, die Verringerung der Größe und der Zahl der Kondensate, die Verhinderung der Umwandlung in Amyloid-Fibrillen und eine gemessene Tau-Bindungsaffinität von Kd 3,95 ± 0,32 μM. IGC-1C war durchlässig und gut verträglich in SH-SY5Y-Zellkulturen. Das Unternehmen plant weitere Tierversuch-validierungsstudien mit dem erklärten Ziel, IGC-1C in klinische Studien zu überführen.
IGC (NYSE American: IGC) أعلنت عن بيانات ما قبل السريرية في المختبر لــ IGC-1C في 7 أكتوبر 2025، وصفت مقاربة جديدة تستهدف بروتين tau من خلال فصل الطور السائل-السائل (LLPS).
تشمل النتائج الرئيسية كبت وتفكيك المركبات tau المرتبطة بالزنك، تقليل حجم وعدد التجمعات، منع التحول إلى الألياف الأميلويدية، وتقدير ارتباط tau بمقدار Kd 3.95 ± 0.32 μM. كان IGC-1C ناقلاً ببساطة في زراعات خلايا SH-SY5Y ومتحملاً جيداً. تخطط الشركة لدراسات تحقق حيواني إضافية بهدف واضح المضي قدماً بـ IGC-1C نحو التجارب السريرية.
IGC (NYSE American: IGC) 于 2025 年 10 月 7 日宣布了 IGC-1C 的体外前临床数据，描述了一种针对 tau 蛋白的新方法，利用 液-液相分离（LLPS）。
要点包括抑制和溶解锌介导的 tau 场聚集体，减少聚集体的大小和数量，防止其转变为淀粉样纤维，以及测得的 tau 结合亲和力为 Kd 3.95 ± 0.32 μM。IGC-1C 在 SH-SY5Y 细胞培养中具有透性且耐受良好。公司计划进行进一步的动物验证研究，目标是将 IGC-1C 推进至临床试验阶段。
- Binding affinity to tau: Kd 3.95 ± 0.32 μM
- Inhibits and dissolves zinc-mediated tau condensates
- Reduces condensate size/number and fibril conversion
- Permeable and well tolerated in SH-SY5Y cell cultures
- Program remains preclinical; no animal efficacy data reported
- No clinical or human safety data available yet
- Potency reported in low micromolar range, not nanomolar
Insights
IGC Pharma reports preclinical in‑vitro activity for IGC-1C, showing tau LLPS modulation and a Kd of 3.95 ± 0.32 μM.
IGC-1C acts on the tau protein's liquid‑liquid phase separation (LLPS) stage, inhibiting and dissolving zinc‑mediated tau condensates and reducing their maturation into amyloid fibrils. The compound showed cellular permeability and tolerability in SH‑SY5Y cultures and a measured dissociation constant to tau of 3.95 ± 0.32 μM, supporting target engagement at low micromolar concentrations.
Key dependencies and risks include validation in animal models and reproducibility of both dissolution and inhibition effects outside the in‑vitro zinc‑mediated assay. The program's next step is additional in vivo validation; progress to animal efficacy and safety studies will be the concrete milestones to watch over the coming months to years.
IGC-1C Targets Tau Protein's Liquid-Liquid Phase Separation (LLPS), Posing a Novel Threat to Neurotoxic Tangles; High Binding Affinity Confirmed
POTOMAC, MD, 1734 / ACCESS Newswire / October 7, 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 in-vitro findings for IGC-1C, a low-molecular weight compound. The data are consistent with IGC-1C acting as a modulator of the tau protein's liquid-liquid phase separation (LLPS), an emerging and critical pathway implicated in the earliest stages of Alzheimer's disease and related tauopathies.
The LLPS pathway represents a potential paradigm shift in neurodegenerative research. When dysregulated, tau protein separates into liquid-like droplets, or condensates, which serve as the pathological "seeds" that mature into neurotoxic fibrillar aggregates (neurofibrillary tangles). By targeting the initial LLPS stage, IGC-1C offers the potential to halt the disease progression before irreversible damage occurs, a therapeutic approach distinct from late-stage plaque or tangle inhibitors.
"IGC-1C can potentially target a key and early pathological event in Alzheimer's disease. By intervening at the phase separation stage, we aim to prevent the formation of toxic tau aggregates, opening a novel and potentially scalable pathway to halt disease progression. This is a disruptive therapeutic concept that has the potential to redefine the treatment landscape for Alzheimer's and other tauopathies." Said, Ram Mukunda, CEO of IGC Pharma.
Key Preclinical Findings: A Potent New Mechanism
Preclinical experimental findings suggest IGC-1C's mechanism of action and demonstrate powerful efficacy markers:
Inhibition & Dissolution Observed: IGC-1C was shown to inhibit the formation of zinc-mediated tau condensates and, critically, promote their dissolution. This dual-action ability suggests IGC-1C can both prevent and potentially reverse the initial pathological step.
High Therapeutic Affinity: IGC-1C demonstrated a strong binding affinity to tau, exhibiting a dissociation constant with tau of (Kd) 3.95 ± 0.32 μM. This low micromolar-range affinity is a positive signal in drug development, reinforcing IGC-1C's efficacy in modulating the tau protein crucial for neurofibrillary tangle formation.
Targeting Key Drivers: Microscopy and fluorescence assays demonstrated that IGC-1C reduces both the size and number of tau-zinc condensates and reduced their conversion into toxic amyloid fibrils.
Cellular Compatibility: In neuroblastoma (SH-SY5Y) cell cultures, IGC-1C was well tolerated and permeable, confirming cellular compatibility.
Designed for Efficacy: Its structure integrates three distinct chemical motifs to maximize efficacy:
Zinc Chelation: Binds to zinc via a dipicolylamine group, a critical element often implicated in driving tau condensation.
Interaction Disruption: Disrupts hydrophobic and interactions through a naphthalimide and aromatic ring.
Multivalency Stabilization: Stabilizes multivalent interactions with its cyclic dipeptide core.
This program explores an approach to Alzheimer's disease and tauopathies by:
Creating a Unique Pipeline Asset: IGC-1C represents a therapeutic concept, distinctly positioned from classical tau aggregation inhibitors or tau-targeted immunotherapies currently in development.
Expanding Therapeutic Reach: Given that LLPS is also implicated in other conditions such as cancer and other neurodegenerative diseases (e.g., ALS), the platform behind IGC-1C holds potential to expand the company's pipeline across multiple therapeutic areas.
IGC Pharma is advancing the IGC-1C program and intends to move forward with additional validation studies in animal models, with the long-term goal of accelerating this candidate toward clinical trials.
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 IGC-1C on October 7, 2025?
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