Annovis Announces Novel Biomarker Data in Alzheimer’s Patients Supporting Buntanetap’s Potential as a Disease-Modifying Treatment
Annovis (NYSE: ANVS) reported novel biomarker results from its Phase 2/3 Alzheimer's study (NCT05686044) showing that buntanetap reduced inflammatory markers IL-5, IL-6, S100A12, IFN-γ, IGF1R and lowered NFL after three months. Responses were seen in all patients with positive pTau217, including mild and moderate stages. Company cites prior cognitive benefit in mild AD and notes buntanetap is being evaluated in a pivotal Phase 3 early AD trial (NCT06709014) with a 6-month symptomatic readout and an 18-month disease-modification readout. Full biomarker data will be presented at CTAD Dec 1-4, 2025.
Annovis (NYSE: ANVS) ha comunicato risultati biomarker inediti dal suo studio di Alzheimer di fase 2/3 (NCT05686044) che mostrano che buntanetap ha ridotto i marker infiammatori IL-5, IL-6, S100A12, IFN-γ, IGF1R e ha diminuito NFL dopo tre mesi. Le risposte sono state osservate in tutti i pazienti con pTau217 positivo, inclusi stadi lievi e moderati. L'azienda cita benefici cognitivi precedenti in Alzheimer lieve e osserva che buntanetap è in valutazione in uno studio clinico chiave di fase 3 in Alzheimer precoce (NCT06709014) con una lettura sintomatica di 6 mesi e una lettura di modifica della malattia di 18 mesi. I dati completi sui biomarcatori saranno presentati al CTAD dal 1 al 4 dicembre 2025.
Annovis (NYSE: ANVS) informó resultados biomarcadores novedosos de su ensayo de Alzheimer de fase 2/3 (NCT05686044) que muestran que buntanetap redujo los marcadores inflamatorios IL-5, IL-6, S100A12, IFN-γ, IGF1R y redujo NFL después de tres meses. Las respuestas se observaron en todos los pacientes con pTau217 positivo, incluyendo etapas leves y moderadas. La empresa cita beneficios cognitivos previos en Alzheimer leve y señala que buntanetap está siendo evaluado en un ensayo pivotal de fase 3 para Alzheimer temprano (NCT06709014) con una lectura sintomática de 6 meses y una lectura de modificación de la enfermedad de 18 meses. Se presentarán los datos completos de biomarcadores en CTAD del 1 al 4 de diciembre de 2025.
Annovis (NYSE: ANVS)가 2/3상 알츠하이머 연구(NCT05686044)에서 새로운 바이오마커 결과를 발표했습니다. buntanetap은 염증 표지자 IL-5, IL-6, S100A12, IFN-γ, IGF1R를 감소시키고 3개월 후 NFL을 낮췄습니다. 양성인 모든 pTau217 환자에서 반응이 관찰되었으며 경도 및 중등도 단계가 포함됩니다. 회사는 경도 AD에서의 인지 이점을 언급하고 buntanetap이 6개월 증상 읽기 및 18개월 질환 수정 읽기를 포함하는 중요한 3상 초기 AD 시험(NCT06709014)에서 평가 중임을 밝힙니다. 전체 바이오마커 데이터는 2025년 12월 1–4일 CTAD에서 발표될 예정입니다.
Annovis (NYSE : ANVS) a publié des résultats biomarqueurs inédits issus de son étude Alzheimer en phase 2/3 (NCT05686044) montrant que buntanetap a réduit les marqueurs inflammatoires IL-5, IL-6, S100A12, IFN-γ, IGF1R et abaissé le NFL après trois mois. Des réponses ont été observées chez tous les patients positifs à pTau217, y compris les stades léger et modéré. L’entreprise cite des bénéfices cognitifs antérieurs dans le MA légère et indique que buntanetap est évalué dans un essai pivot de phase 3 pour l’AD précoce (NCT06709014) avec une lecture symptomatique sur 6 mois et une lecture de modification de la maladie sur 18 mois. Les données complètes sur les biomarqueurs seront présentées au CTAD du 1er au 4 décembre 2025.
Annovis (NYSE: ANVS) berichtete neuartige Biomarker-Ergebnisse aus seiner Phase-2/3-Studie zum Alzheimer (NCT05686044), die zeigen, dass buntanetap entzündliche Marker IL-5, IL-6, S100A12, IFN-γ, IGF1R reduziert und nach drei Monaten NFL senkte. Antworten wurden bei allen Patienten mit pozitivem pTau217 beobachtet, einschließlich leichter und mittlerer Stadien. Das Unternehmen verweist auf frühere kognitive Vorteile bei leichtem AD und weist darauf hin, dass buntanetap in einer richtungsweisenden Phase-3-Studie zum frühen AD evaluiert wird (NCT06709014) mit einer 6-monatigen symptomatischen Auslese und einer 18-monatigen krankheitsmodifizierenden Auslese. Vollständige Biomarker-Daten werden beim CTAD vom 1.–4. Dezember 2025 präsentiert.
Annovis (NYSE: ANVS) أعلنت نتائج بيوماركر جديدة من دراستها للزهايمر في المرحلتين الثانية والثالثة (NCT05686044) تُظهر أن buntanetap خفّضت العلامات الالتهابية IL-5, IL-6, S100A12, IFN-γ, IGF1R وقلّلت NFL بعد ثلاثة أشهر. الاستجابات لوحظت لدى جميع المرضى الإيجابيين لـ pTau217، بما في ذلك المراحل الخفيفة والمتوسطة. تشير الشركة إلى فائدة معرفية سابقة في ALZs الخفيف وتذكر أن buntanetap يُقيَّم في تجربة حاسمة من المرحلة 3 للزهايمر المبكر (NCT06709014) مع قراءة أعراض لمدة 6 أشهر وقراءة تعديل المرض لمدة 18 شهراً. سيتم تقديم البيانات الكاملة للبيوماركر في CTAD من 1 إلى 4 ديسمبر 2025.
Annovis (NYSE: ANVS) 报告其针对阿尔茨海默病的2/3期研究（NCT05686044）的新的生物标志物结果，显示 buntanetap 降低了炎症标志物 IL-5, IL-6, S100A12, IFN-γ, IGF1R，并在三个月后降低了 NFL。在所有 pTau217 呈阳性的患者中都观察到反应，包括轻度和中度阶段。公司提到在轻度AD中之前的认知获益，并指出 buntanetap 正在评估一个关键的III期早发AD试验（NCT06709014），该试验有6个月的症状学读出和18个月的疾病修饰读出。完整的生物标志物数据将于2025年12月1-4日的CTAD会上公布。
- Reduction in inflammatory markers IL-5, IL-6, S100A12, IFN-γ, IGF1R
- Decrease in NFL, indicating improved neuronal integrity
- Biomarker responses observed in all pTau217-positive patients
- Phase 3 early AD trial (NCT06709014) actively enrolling
- Biomarker analysis conducted after only three months of treatment
- Disease-modifying potential unconfirmed until 18-month readout
- No quantitative effect sizes for biomarkers reported in this release
Insights
Biomarker reductions in inflammatory and neuronal‑damage proteins after three months support buntanetap's disease‑modifying potential, congruent with prior clinical signals.
These data show that buntanetap engaged inflammatory pathways and neuronal integrity markers: reductions in IL‑5, IL‑6, S100A12, IFN‑γ, IGF1R and decreased NFL indicate lower peripheral neuroinflammation and less neuronal damage after three months. The effect in all patients with positive pTau217—including mild and moderate stages—strengthens the biomarker‑to‑pathology link and aligns mechanistically with claims of attenuated amyloid accumulation.
Risks and dependencies remain: the analysis duration was short (<3 months) and the release does not report absolute magnitudes, variability, statistical significance, or multiplicity control, so clinical relevance at the individual level is unclear. The claim that biomarker changes will translate to sustained disease modification depends on replicated, statistically robust signals at the planned
Watch for the full dataset at CTAD (
MALVERN, Pa., Oct. 09, 2025 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD), today announced new results that demonstrate buntanetap’s ability to attenuate inflammation and improve cellular health in Alzheimer’s patients, suggesting potential disease-modifying effects beyond symptomatic relief.
The analysis of patient samples from the Phase 2/3 AD study (NCT05686044) revealed that buntanetap targets key biomarkers of neuroinflammation and neurodegeneration. The following inflammatory markers were reduced in the treatment group vs placebo: IL-5, IL-6, S100A12, IFN-γ, and IGF1R. These molecules are known to drive pro-inflammatory responses in AD and have been associated with elevated amyloid-β burden. By modulating these pathways, buntanetap may reduce chronic inflammation and attenuate amyloid accumulation. Equally compelling was the observation that buntanetap decreased levels of NFL, a protein fragment released from damaged neurons, indicating improved cellular integrity and neuronal health. Notably, these responses were observed in all patients with positive pTau217 plasma levels, including those with mild and moderate stages of the disease.
"Alzheimer's disease is multifactorial, and targeting just one of its causes has historically yielded limited therapeutic benefit," commented Maria Maccechini, Ph.D., President and CEO of Annovis. "What makes buntanetap truly promising is its ability to target multiple neurotoxic proteins simultaneously and interrupt the toxic cascade—something we have long believed was necessary for meaningful progress. These biomarker results validate our preclinical and earlier clinical findings and reinforce our confidence that we are on the right track."
Buntanetap has previously demonstrated clinical benefits in the Phase 2/3 study, where mild AD patients saw significant cognitive improvement. The convergence of these findings with the novel biomarker data, which indicate reduced inflammation and improved neuronal health, underscore buntanetap’s promise as a potential disease-modifying therapy that may fundamentally alter the course of Alzheimer’s. Buntanetap is currently being evaluated in a pivotal Phase 3 trial in early AD (NCT06709014), which is actively enrolling and treating patients across the U.S. The study is designed to have a 6-month readout focused on symptomatic improvement and an 18-month readout aimed at assessing disease modification.
“We are highly encouraged by these new biomarker data,” added Cheng Fang, Ph.D., SVP Research & Development. “While the current analysis was conducted in patients after just three months of treatment, it confirmed the target and pathway engagement of buntanetap, only bolstering our confidence in the outcome of the Phase 3 study. Since the biomarker signal typically becomes more evident as the disease advances, we anticipate observing an even stronger treatment response at the 18-month analysis.”
The full biomarker data will be presented during the Clinical Trials on Alzheimer's Disease (CTAD) conference in San Diego, taking place December 1-4, 2025. Additional details regarding the presentation will be announced closer to the conference date via a separate news release.
About Annovis
Headquartered in Malvern, Pennsylvania, Annovis is dedicated to addressing neurodegeneration in diseases such as Alzheimer’s disease (AD) and Parkinson’s disease (PD). The Company is committed to developing innovative therapies that improve patient outcomes and quality of life. For more information, visit www.annovisbio.com and follow us on LinkedIn, YouTube, and X.
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This press release contains forward-looking statements under the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended. Actual results may differ due to various risks and uncertainties, including those outlined in the Company’s SEC filings under “Risk Factors” in its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. The Company undertakes no obligation to update forward-looking statements except as required by law.
Contact Information:
Annovis Bio Inc.
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Malvern, PA 19355
www.annovisbio.com
Investor Contact:
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Annovis Bio
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FAQ
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