Annovis Reports Peer-Reviewed Publication Highlighting Pharmacokinetics of Novel Crystal Buntanetap
Annovis Bio (NYSE:ANVS) announced a peer-reviewed publication in Biomolecules detailing the pharmacokinetic profile of a new crystal form of buntanetap, their lead drug candidate for neurodegenerative diseases. The new dihydrate crystal form demonstrates enhanced stability while maintaining the same pharmacokinetic profile and metabolism as the original anhydrous form.
The crystal buntanetap is currently being utilized in a Phase 3 clinical trial for early Alzheimer's disease, with key readouts expected in Fall 2026 (symptomatic) and Fall 2027 (disease-modifying). Importantly, this new formulation extends the company's intellectual property protection into the 2040s.
Annovis Bio (NYSE:ANVS) ha annunciato una pubblicazione peer-reviewed su Biomolecules che descrive il profilo farmacocinetico di una nuova forma cristallina di buntanetap, candidato principale dell'azienda per malattie neurodegenerative. La nuova forma cristallina di diidrato mostra una stabilità migliorata mantenendo lo stesso profilo farmacocinetico e lo stesso metabolismo della forma anidra originale.
Il cristallo buntanetap è attualmente impiegato in una fase 3 di trial clinico per la malattia di Alzheimer in fase iniziale, con i principali esiti attesi nell'autunno 2026 (sintomatici) e nell'autunno 2027 (modificazione della malattia). Importante, questa nuova formulazione estende la protezione della proprietà intellettuale dell'azienda fino al 2040.
Annovis Bio (NYSE:ANVS) anunció una publicación revisada por pares en Biomolecules que detalla el perfil farmacocinético de una nueva forma cristalina de buntanetap, su fármaco principal para enfermedades neurodegenerativas. La nueva forma cristalina dihidratada demuestra mayor estabilidad mientras mantiene el mismo perfil farmacocinético y metabolismo que la forma anhidra original.
El cristal buntanetap se está utilizando actualmente en un ensayo clínico de fase 3 para la enfermedad de Alzheimer en etapas tempranas, con resultados clave esperados en otoño de 2026 (sintomáticos) y otoño de 2027 (modificación de la enfermedad). Importante, esta nueva formulación extiende la protección de la propiedad intelectual de la empresa hasta la década de 2040.
Annovis Bio (NYSE:ANVS)는 Biomolecules에 동료 심사를 거친 논문을 발표했고, 신형 buntanetap의 약동학적 프로필과 신 결정 형태를 상세히 설명합니다. 새로운 수히드레이트 결정 형태는 원래의 무수 형태와 동일한 약동학적 프로필과 대사를 유지하면서도 안정성을 개선합니다.
크리스탈 buntanetap은 현재 초기 알츠하이머병을 대상으로 하는 3상 임상시험에 사용 중이며, 주요 결과는 2026년 가을(증상) 및 2027년 가을(질병 수정)로 예상됩니다. 중요한 점은 이 새로운 제형이 회사의 지적 재산권 보호를 2040년대까지 확장한다는 것입니다.
Annovis Bio (NYSE:ANVS) a annoncé une publication évaluée par les pairs dans Biomolecules décrivant le profil pharmacocinétique d'une nouvelle forme cristalline de buntanetap, candidat principal de l'entreprise pour les maladies neurodégénératives. La nouvelle forme cristalline dihydratée présente une stabilité accrue tout en conservant le même profil pharmacocinétique et le même métabolisme que la forme anhydre d'origine.
Le cristal buntanetap est actuellement utilisé dans un essai clinique de phase 3 pour la maladie d'Alzheimer à un stade précoce, avec des résultats clés attendus à l'automne 2026 (symptomatique) et à l'automne 2027 (modification de la maladie). Important : cette nouvelle formulation étend la protection de la propriété intellectuelle de l'entreprise jusqu'aux années 2040.
Annovis Bio (NYSE:ANVS) hat eine peer-reviewed Veröffentlichung in Biomolecules bekannt gegeben, die das pharmacokinetische Profil einer neuen Kristallform von buntanetap, dem führenden Wirkstoffkandidaten des Unternehmens gegen neurodegenerative Erkrankungen, beschreibt. Die neue Hydrat-Kristallform zeigt eine verbesserte Stabilität, behält jedoch das gleiche pharmakokinetische Profil und denselben Stoffwechsel wie die ursprüngliche anhydre Form bei.
Der Kristall buntanetap wird derzeit in einer Phase-3-Studie für frühe Alzheimer-Erkrankung verwendet, mit wichtigen Ergebnissen voraussichtlich im Herbst 2026 (symptomatisch) und Herbst 2027 (disease-modifying). Wichtig: Diese neue Formulierung verlängert den Schutz des geistigen Eigentums des Unternehmens bis in die 2040er.
Annovis Bio (NYSE:ANVS) أعلنت عن نشر مُراجَع من قبل الأقران في Biomolecules يوضح الملف الدوائي-الحركي لشكل بلوري جديد من buntanetap، وهو المرشح الرئيسي للشركة للأمراض التنكسية العصبية. الشكل البلوري الهيدراتي الجديد يُظهر استقراراً محسنًا مع الحفاظ على نفس الملف الدوائي-الحركي والتمثيل الغذائي كما في الشكل غير المائي الأصلي.
يُستخدم البلور buntanetap حاليًا في تجربة سريرية من المرحلة 3 لمرض الزهايمر في مراحله المبكرة، مع توقع قراءات رئيسية في خريف 2026 (أعراض) وخريف 2027 (تعديل المرض). والأهم أن هذا الصيغـة الجديدة تمد حماية الملكية الفكرية للشركة حتى أواخر الأربعينيات.
Annovis Bio (NYSE:ANVS) 在 Biomolecules 发表了一项同行评审的研究，详细介绍 buntanetap 的药代动力学特征，这是其针对神经退行性疾病的候选药物。新的 二水合晶体形态 显示出更高的稳定性，同时保持与原始无水形态相同的药代动力学特征和代谢。
该晶体 buntanetap 目前用于早期阿尔茨海默病的 III 期临床试验，关键结果预计在 2026 年秋季（症状性）和 2027 年秋季（疾病修饰）。重要的是，这一新制剂将公司的知识产权保护推至 2040 年代。
- New crystal form offers greater stability while maintaining therapeutic efficacy
- Extended intellectual property protection into the 2040s
- Active Phase 3 trial with two key readouts scheduled for 2026 and 2027
- None.
Insights
Annovis's new crystal form of buntanetap maintains its pharmacokinetic profile while offering improved stability and extended patent protection.
The peer-reviewed publication in Biomolecules represents an important technical advancement for Annovis's lead drug candidate. The company has developed a new dihydrate crystal form of buntanetap that incorporates two water molecules into its structure, providing enhanced stability compared to the original anhydrous form used in previous studies.
What's particularly significant is that this new crystal form maintains the same pharmacokinetic (PK) profile and metabolism as the original form. PK properties—how a drug is absorbed, distributed, metabolized, and eliminated—are critical determinants of therapeutic efficacy. The fact that these properties remain consistent between formulations is essential for maintaining the drug's potential therapeutic benefits while gaining stability advantages.
Perhaps most strategically important, this new crystal form extends intellectual property protection into the 2040s, significantly lengthening Annovis's market exclusivity period. This patent extension covers the mechanism of action, therapeutic applications, and potential combination therapies.
The new crystal formulation is already being implemented in Annovis's pivotal Phase 3 trial for early Alzheimer's disease (NCT06709014), which aims to deliver symptomatic efficacy results by Fall 2026 and disease-modifying outcome data by Fall 2027. This suggests the company has sufficient confidence in the new formulation to incorporate it directly into its most advanced clinical program.
MALVERN, Pa., Sept. 16, 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 the publication of a new article in a peer-reviewed journal Biomolecules, which describes the pharmacokinetic (PK) profile of a new crystal form of buntanetap and compares it to the old form across several studies including mice, dogs, and humans.
The original anhydrous form of buntanetap has been used in all preclinical and clinical studies to date. Recently, the Annovis team identified a new dihydrate crystal, which incorporates two moles of water in its structure and offers greater stability. This publication examines how the new crystal form behaves in the body following oral administration, focusing on absorption and clearance. The findings confirm that crystal buntanetap preserves the PK profile and metabolism of the original form, which are essential for the drug’s therapeutic efficacy.
“We have highlighted the new form of buntanetap in prior presentations, but this open-access publication presents the data in full to a broader audience. It not only validates the use of crystal buntanetap in clinical trials but also reinforces the consistency and reliability of our lead asset,” said Alexander Morin, Ph.D., Director of Strategic Communications. “PK is central to understanding how a drug works, and we remain committed to rigorous analysis of buntanetap to ensure the most beneficial outcomes for patients.”
The new crystal buntanetap is currently being used in the pivotal Phase 3 clinical trial (NCT06709014) in patients with early AD, which is actively enrolling participants across the U.S. The study is designed to deliver two key readouts: symptomatic (Fall 2026) and disease-modifying (Fall 2027). Moreover, this new form extends the intellectual property protection of the Company’s lead compound into the 2040s, covering its mechanism of action, therapeutic use, and combination with other drugs.
The publication can be accessed online via the LINK or found in the Publications library on Annovis’ website.
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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Forward-Looking Statements
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.
101 Lindenwood Drive
Suite 225
Malvern, PA 19355
www.annovisbio.com
Investor Contact:
Alexander Morin, Ph.D.
Director, Strategic Communications
Annovis Bio
ir@annovisbio.com
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/b56f10e2-7690-4b2a-85bc-cb17a3e3bd43
FAQ
What is the new crystal form of buntanetap announced by Annovis Bio (NYSE:ANVS)?
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