A 6-month & 18-month Prospective, Randomized, Placebo-controlled, Double-blind Dual Clinical Trial Investigating Efficacy and Safety of Buntanetap in Treating Participants of Early Alzheimer's Disease

The goal of this clinical trial is to learn if buntanetap/Posiphen works to treat early Alzheimer's disease in adults aged 55-85. It will also learn about the safety of buntanetap/Posiphen. The main questions it aims to answer are:
* Does buntanetap/Posiphen improve cognition as measured by ADAS-Cog13?
* Does buntanetap/Posiphen improve function as measured by ADCS-iADL?
* What medical issues do participants have, if any, when taking buntanetap/Posiphen?
Researchers will compare buntanetap/Posiphen to a placebo (a look-alike substance that contains no drug) to see if buntanetap/Posiphen works to treat early Alzheimer's disease.
Participants will:
* Take buntanetap/Posiphen or a placebo every day for 18 months
* Visit the clinic periodically for checkups, tests, and questionnaires (screening visits, enrollment, month 1, month 3, month 6, month 9, month 12, month 15, month 18), including a volumetric MRI at month 6 and month 18
* Complete pre- and post-clinic visit phone calls

Start Date04 Feb 2025

Sponsor / Collaborator

Annovis Bio, Inc.

[+1]

NCT05686044

/ CompletedPhase 2/3

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Multicenter Study of Buntanetap in Participants With Mild to Moderate Alzheimer's Disease

The purpose of this study is to measure efficacy and safety of three different doses of buntanetap/Posiphen compared with placebo in participants with mild to moderate Alzheimer's disease.
Study details include:
The double-blind treatment duration will include a screening period of up to 42 days followed by 12 weeks of treatment at home.
The study duration will be 4-5 months. There will be 4 in-clinic visits and 1 phone call.

Start Date01 Apr 2023

Sponsor / Collaborator

Annovis Bio, Inc.

NCT05357989

/ CompletedPhase 3

A 6-month Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial Investigating the Efficacy, Safety, and Tolerability of Two Different Doses of Buntanetap or Placebo in Patients With Early Parkinson's Disease

The purpose of this study is to measure safety and efficacy of buntanetap/posiphen capsules compared with placebo capsules in participants with early PD.
Study details include:
* The study duration will be up to 7-8 months.
* The double-blind treatment duration will be up to 6 months.
* There will be 5 in-clinic visits and 7 phone calls

Start Date03 Aug 2022

Sponsor / Collaborator

Annovis Bio, Inc.

[+1]

100 Clinical Results associated with Buntanetap

100 Translational Medicine associated with Buntanetap

100 Patents (Medical) associated with Buntanetap

Literatures (Medical) associated with Buntanetap

01 Apr 2024·SLAS Discovery

Real-time thiol detection in iPSC-derived neuron cultures using SemKur-IM, a novel fluorescent dithio probe

Article

Author: Hendrickson, Michael ; Kurfis, Jayson ; Alvarez, Roxanne ; Sem, Daniel S

Neurological disorders associated with inflammation and oxidative stress show reduced glutathione (GSH) levels in the human brain. Drug discovery efforts and pharmacological studies would benefit from tools (e.g. chemical probes) that detect changes to oxidative stress, from the perspective of physiologically-relevant reporters like cellular thiols, including GSH. To this end, we have developed a fluorescence visualization assay using iPSC-derived cortical glutamatergic neurons that were loaded with 25 μM of a novel thiol-detection fluorescent probe, SemKur-IM. This probe enables visualization of cellular thiol level changes in the neuronal somas and neurites, in response exposure to N-acetyl-cysteine (NAC). Cellular thiol redox state was observed to change, based on an increase in green fluorescence (485 nm excitation maximum; 525 nm emission maximum) due to changes in thiol levels, from 0 to 40 mM. Interestingly, prior to treatment with NAC, cells did not appear to have significant levels of reduced thiols. Our studies demonstrate the utility of SemKur-IM in the detection of thiol levels in live cells in response to chemical exposures, such as from drugs that return the cell to a healthier reduced state. An initial application to screening the effects of an Alzheimer's disease drug candidate, Posiphen, using fluorescence cell sorting is presented. Other potential applications include high throughput screening of central nervous system (CNS) drugs thought to work by affecting cellular redox state in neurons.

01 Jan 2023·The Journal of Prevention of Alzheimer's Disease

Buntanetap, a Novel Translational Inhibitor of Multiple Neurotoxic Proteins, Proves to Be Safe and Promising in Both Alzheimer's and Parkinson's Patients

Article

Author: Damiano, E ; Liow, K ; Zetterberg, H ; Maccecchini, M ; Feng, D ; Hernandez, P ; Fang, C ; Blennow, K ; Chen, M

BACKGROUNDPreviously we reported the clinical safety and pharmacological activity of buntanetap (known as Posiphen or ANVS401) in healthy volunteers and mild cognitive impaired (MCI) patients (21). The data supported continued clinical evaluation of buntanetap for treating Alzheimer's Disease (AD). Neurodegenerative diseases such as AD and Parkinson's disease (PD) share several pathological manifestations, including increased levels of multiple neurotoxic protein aggregates. Therefore, a treatment strategy that targets toxic species common to both disorders can potentially provide better clinical outcomes than attacking one neurotoxic protein alone. To test this hypothesis, we recently completed a clinical study in early AD and early PD participants and report the data here.OBJECTIVESWe evaluated safety, pharmacokinetics, biomarkers, and efficacy of buntanetap in treating early AD and PD patients.DESIGNDouble-blind, placebo-controlled, multi-center study.SETTING13 sites in the US participated in this clinical trial. The registration number is NCT04524351 at ClinicalTrials.gov.PARTICIPANTS14 early AD patients and 54 early PD patients.INTERVENTIONAD patients were given either 80mg buntanetap or placebo QD. PD patients were given 5mg, 10mg, 20mg, 40mg, 80mg buntanetap or placebo QD.MEASUREMENTSPrimary endpoint is safety and tolerability; secondary endpoint is pharmacokinetics of buntanetap in plasma; exploratory endpoints are 1) biomarkers in cerebrospinal fluid (CSF) in both AD and PD patients 2) psychometric tests specific for AD (ADAS-Cogs and WAIS coding test) or PD (MDS-UPDRS and WAIS coding test).RESULTSBuntanetap was safe and well tolerated. Biomarker data indicated a trend in lowering levels of neurotoxic proteins and inflammatory factors and improving axonal integrity and synaptic function in both AD and PD cohorts. Psychometric tests showed statistically significant improvements in ADAS-Cog11 and WAIS coding in AD patients and MDS-UPDRS and WAIS coding in PD patients.CONCLUSIONSBuntanetap is well tolerated and safe at doses up to 80mg QD in both AD and PD patients. Cmax and AUC increase with dose without evidence for a plateau up to 80mg QD. The drug shows promising evidence in exploratory biomarker and efficacy measures. Further evaluation of buntanetap in larger, longer-term clinical trials for the treatment of AD and PD are warranted.

11 Feb 2022·ACS Pharmacology & Translational Science

In Silico and Ex Vivo Analyses of the Inhibitory Action of the Alzheimer Drug Posiphen and Primary Metabolites with Human Acetyl- and Butyrylcholinesterase Enzymes

Article

Author: Furqan, Tiyyaba ; Hasan Mahmood, Muhammad Sibte ; Greig, Nigel H. ; Batool, Sidra ; Kamal, Mohammad A. ; Tweedie, David

Alzheimer's disease (AD) is the most common neurodegenerative disorder worldwide. Ongoing research to develop AD treatments has characterized multiple drug targets including the cholinergic system, amyloid-β peptide, phosphorylated tau, and neuroinflammation. These systems have the potential to interact to either drive or slow AD progression. Promising agents that simultaneously impact many of these drug targets are the AD experimental drug Posiphen and its enantiomer phenserine that, currently, are separately being evaluated in clinical trials. To define the cholinergic component of these agents, the anticholinesterase activities of a ligand dataset comprising Posiphen and primary metabolites ((+)-N1-norPosiphen, (+)-N8-norPosiphen, and (+)-N1,N8-bisnorPosiphen) were characterized and compared to those of the enantiomer phenserine. The "target" dataset involved the human cholinesterase enzymes acetylcholinesterase (AChE) and butyrylcholinesterase (BChE). Binding interactions between the ligands and targets were analyzed using Autodock 4.2. The computationally determined inhibitory action of these ligands was then compared to ex vivo laboratory-measured values versus human AChE and BChE. While Posiphen lacked AChE inhibitory action, its major and minor metabolites (+)-N1-norPosiphen and (+)-N1,N8-bisnorPosiphen, respectively, possessed modest AChE inhibitory activity, and Posiphen and all metabolites lacked BChE action. Phenserine, as a positive control, demonstrated AChE-selective inhibitory action. In light of AChE inhibitory action deriving from a major and minor Posiphen metabolite, current Posiphen clinical trials in AD and related disorders should additionally evaluate AChE inhibition; particularly if Posiphen should be combined with a known anticholinesterase, since this drug class is clinically approved and the standard of care for AD subjects, and excessive AChE inhibition may impact drug tolerability.

118

News (Medical) associated with Buntanetap

22 Apr 2025

·www.prnewswire.com

XADAGO/EQUFINA Set to Revolutionize Parkinson's Disease Treatment Landscape | DelveInsight

As a selective monoamine oxidase B (MAO-B) inhibitor, XADAGO offers a unique mechanism of action that complements traditional therapies, potentially improving motor function and reducing "off" time in patients. The increasing prevalence of Parkinson's disease and the growing demand for effective therapies create a substantial market opportunity for XADAGO, particularly in regions with aging populations. LAS VEGAS, April 22, 2025 /PRNewswire/ -- DelveInsight's " XADAGO/EQUFINA Market Size, Forecast, and Market Insight Report" highlights the details around XADAGO/EQUFINA, an inhibitor of monoamine oxidase B (MAO-B) indicated as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of XADAGO/EQUFINA. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Newron Pharmaceuticals/Eisai/Meiji Seika Pharma's XADAGO/EQUFINA (safinamide) Overview XADAGO is a monoamine oxidase B (MAO-B) inhibitor used alongside levodopa/carbidopa to help manage "off" episodes in individuals with Parkinson's disease. While its exact mode of action in treating Parkinson's is not fully understood, it is thought to work by inhibiting MAO-B, thereby reducing dopamine breakdown. This leads to increased dopamine levels and enhanced dopaminergic activity in the brain. XADAGO contains the active ingredient safinamide in the form of a mesylate salt and is available in 50 mg and 100 mg film-coated oral tablets. Each tablet provides either 65.88 mg or 131.76 mg of safinamide mesylate, equivalent to 50 mg or 100 mg of the safinamide base. The medication is marketed as XADAGO in the United States and Europe and under the name EQUFINA in Japan. Learn more about XADAGO/EQUFINA projected market size for Parkinson's disease @ XADAGO/EQUFINA Market Potential Parkinson's disease is a progressive neurological disorder that mainly impairs movement control. It results from the slow degeneration of dopamine-producing neurons in the brain, especially in the substantia nigra, a region crucial for managing voluntary motor function. According to estimates by DelveInsight, there were 2.7 million diagnosed prevalent cases of Parkinson's disease in the 7MM in 2023, with the United States accounting for around 45% of these cases. While a cure for Parkinson's remains elusive, a combination of pharmacological and non-pharmacological therapies is used to manage symptoms. Physical, occupational, and speech therapies form key components of treatment, and surgical procedures may benefit select patients. Additionally, complementary therapies are sometimes employed to help address particular symptoms. Frequently prescribed medications for Parkinson's include levodopa, dopamine agonists, MAO-B inhibitors, COMT inhibitors, amantadine, anticholinergics, and adenosine A2A antagonists. These treatments primarily target motor symptoms, which are a major concern for those affected. DelveInsight reports that the Parkinson's disease market in the 7MM was valued at USD 3.2 billion in 2023. The market is expected to grow over the forecast period (2020–2034), fueled by the launch of new therapies, increasing prevalence, better access to healthcare, and rising demand for more advanced and effective treatment options. Discover more about the Parkinson's disease market in detail @ Parkinson's Disease Market Report Emerging Competitors of XADAGO/EQUFINA Some of the drugs in the pipeline include Solengepras (Cerevance), Minzasolmin (UCB Biopharma SRL/Novartis), Buntanetap (Annovis Bio), and others. Buntanetap has successfully completed Phase III trials for early-stage Parkinson's disease. Annovis Bio has scheduled a meeting with the FDA in Q1 2025 to determine the development path forward for Buntanetap in the treatment of Parkinson's disease. Buntanetap is also being developed for Alzheimer's disease, Lewy Body Dementia, and other neurodegenerative disorders. In November 2024, Cerevance announced the dosing of the first patient in its pivotal Phase III ARISE trial, evaluating solengepras as a potential adjunctive treatment for Parkinson's disease. Cerevance expects to report topline data in the first half of 2026. In December 2021, UCB partnered with Novartis to globally co-develop and co-commercialize UCB0599, a pioneering alpha-synuclein misfolding inhibitor currently in Phase II clinical trials for Parkinson's disease. To know more about the number of competing drugs in development, visit @ XADAGO/EQUFINA Market Positioning Compared to Other Drugs Key Milestones of XADAGO/EQUFINA In April 2020, Newron Pharmaceutical acknowledged that US WorldMeds, who held the US commercialization rights for the licensed drug, XADAGO, as a sub licensee of Zambon, had entered into a definitive agreement with Supernus Pharmaceuticals under which Supernus would acquire the CNS portfolio of US WorldMeds, including the US rights to XADAGO In November 2019, Eisai announced that it had launched the EQUFINA 50mg tablets for the indication of improvement of the wearing-off phenomenon in patients with Parkinson's disease under treatment with a drug containing levodopa in Japan. Manufacturing and marketing approval of EQUFINA was obtained in September 2019. In April 2017, Eisai Co., Ltd. and Meiji Seika Pharma announced entering into a license agreement for the commercialization of safinamide (development code: ME2125) to treat Parkinson's disease in Japan and Asia. In March 2017, Newron Pharmaceuticals announced the US FDA approval of XADAGO to treat Parkinson's disease as an add-on therapy to levodopa/carbidopa for patients experiencing "off" episodes. In March 2016, Zambon announced a strategic agreement with US WorldMeds to commercialize Newron's lead compound, XADAGO, to treat Parkinson's disease in the US. In February 2015, XADAGO was approved in the European Union as an add-on therapy to levodopa, alone or in combination with other Parkinson's medications, in mid-late stage PD patients with motor fluctuations. XADAGO/EQUFINA Patent Details XADAGO tablets are currently protected by three XADAGO patents with US patent numbers 8,076,515, 8,278,485, and 8,283,380, which expire between June 2027 and December 2028 and are listed in the FDA's publication, Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the Orange Book. The company has a license agreement with Zambon S.p.A., Newron's partner, related to the XADAGO Patents, and as a new chemical entity, XADAGO is under the 5-year FDA exclusivity period that expires on March 21, 2022. In May 2017, Zambon filed a worldwide patent under the patent number WO2017207587A1. The invention relates to pharmaceutical compositions comprising safinamide and, more particularly, to taste-masked particles comprising said active ingredient or pharmaceutically acceptable salts thereof, oral dosage forms that include said particles, and a process for preparing them. Discover how XADAGO/EQUFINA is shaping the Parkinson's disease treatment landscape @ XADAGO 50mg XADAGO/EQUFINA Market Dynamics XADAGO, marketed as EQUFINA in some regions (notably in South Korea and Japan), is a once-daily oral selective MAO-B inhibitor used as an add-on treatment for Parkinson's disease patients experiencing "off" episodes while on a stable dose of levodopa. The drug's unique dual mechanism of action—MAO-B inhibition and modulation of glutamate release—offers both dopaminergic and non-dopaminergic effects, positioning it as a differentiated product in the PD adjunctive therapy landscape. This has helped it carve a niche in markets where patients are inadequately controlled by levodopa alone, particularly those in mid-to-late-stage PD. The global market dynamics for XADAGO/EQUFINA are shaped by a mix of competitive intensity, regional adoption trends, and payer dynamics. In the U.S. and Europe, the drug has faced stiff competition from generic MAO-B inhibitors (like selegiline and rasagiline) and newer Parkinson's disease therapies, including COMT inhibitors, dopamine agonists, and extended-release levodopa formulations. Despite this, its favorable safety profile and once-daily dosing have supported its uptake in certain patient segments, especially in Europe. Market penetration has been slower in the U.S. due to both reimbursement hurdles and physician preference for more established adjunctive treatments. In Asia, particularly Japan and South Korea, EQUFINA has demonstrated stronger market performance thanks to focused commercial strategies and a high unmet need for effective "off time" management. Meiji Seika Pharma and Eisai, the regional marketing partners, have successfully leveraged the drug's differentiated profile in clinician education, which has led to growing adoption among neurologists. In Japan, where the aging population is rapidly expanding and Parkinson's prevalence is rising, EQUFINA has benefited from both demographic tailwinds and formulary access. Looking ahead, the market outlook for XADAGO/EQUFINA depends on several strategic levers, including lifecycle management, regional partnerships, and real-world evidence generation. The manufacturer's ability to expand into new geographies, secure favorable reimbursement, and differentiate against both generics and newer entrants will be critical. Moreover, as Parkinson's disease treatment moves toward more personalized approaches, XADAGO/EQUFINA may find sustained relevance in specific subpopulations, particularly those requiring a balance of efficacy and tolerability. Dive deeper to get more insight into XADAGO/EQUFINA's strengths & weaknesses relative to competitors @ XADAGO/EQUFINA Market Drug Report Table of Contents Related Reports Parkinson's Disease Market Parkinson's Disease Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Parkinson's disease companies, including UCB Biopharma SRL, Novartis, Annovis Bio, Supernus Pharmaceuticals, Inc., Britannia Pharmaceutical, Pharma Two B, Mitsubishi Tanabe Pharma (NeuroDerm), AbbVie, Cerevel Therapeutics, Cerevance, among others. Parkinson's Disease Pipeline Parkinson's Disease Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Parkinson's disease companies, including Cerevel Therapeutics, Inhibikase Therapeutics, Neuraly, Peptron, Biogen, Roche, Brain Neurotherapy Bio, Inc., Modag, Annovis Bio Inc., BioVie Inc., United Neuroscience Ltd., Luye Pharma Group, AbbVie, UCB Biopharma SRL, InnoMedica Schweiz AG, Integrative Research Laboratories AB, H. Lundbeck A/S, Shanghai WD Pharmaceutical Co., Ltd., Cerevance Beta, Inc., Nobilis Therapeutics Inc., BlueRock Therapeutics, Taiwan Mitochondrion Applied Technology Co., Ltd., among others. Cell and Gene Therapy in Parkinson's Disease Market Cell and Gene Therapy in Parkinson's Disease Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key cell and gene therapy in Parkinson's disease companies including MeiraGTx, Hope Biosciences, Sumitomo Pharma, Prevail Therapeutics, BlueRock Therapeutics, Voyager Therapeutics, among others. Parkinson's Disease Psychosis Market Parkinson's Disease Psychosis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Parkinson's disease psychosis companies, including Sumitomo Pharma America Inc., Vanda Pharmaceuticals, Acadia Pharmaceuticals Inc., Otsuka America Pharmaceutical, Lundbeck LLC, Jazz Pharmaceuticals, Alkahest Inc., Sandoz, Sio Gene Therapies, Axovant Sciences Ltd, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Drug ApprovalLicense out/inPhase 2

25 Mar 2025

·www.globenewswire.com

Annovis to Attend AD/PD™ 2025 with Extensive Scientific Program

MALVERN, Pa., March 25, 2025 (GLOBE NEWSWIRE) -- Annovis Bio Inc. (NYSE: ANVS) ("Annovis"), 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 its participation in the AD/PD™ 2025 taking place April 1-5 in Vienna. "We are at a pivotal moment in our company’s journey as we have entered the late clinical stages for both Alzheimer’s and Parkinson’s. It is incredibly rewarding to see our work bring us here, once again supporting that our drug is efficacious and safe across both indications,” commented Maria Maccecchini, Ph.D., Founder and CEO of Annovis. “At this meeting, we will present comprehensive data from our latest Phase 3 PD and Phase 2/3 AD studies. For Parkinson’s, we will take a deeper look into the cognitive response, while for Alzheimer’s, we will dive into the advantages of buntanetap for APOE4 carriers, addressing a pressing challenge in existing AD therapies." Annovis will give two presentations and participate in a forum discussion: Presentation: BUNTANETAP IMPROVES EARLY PARKINSON’S PATIENTS’ COGNITION AND MOTOR FUNCTIONS IN A PHASE 3 STUDY Date: April 1Time: 2:45 – 3:00 pm CETPresenter: Maria Maccecchini, Ph.D., Founder and CEO Presentation: APOE4 AND BUNTANETAP IN PHASE II/III ALZHEIMER’S PATIENTS Date: April 2Time: 9:40 – 9:55 am CETPresenter: Cheng Fang, Ph.D., SVP, Research and Development Forum: NOVEL APPROACHES TO ACCELERATE DEVELOPMENT OF BIOMARKERS, IMAGING, AND THERAPY OF ALPHA-SYNUCLEIN, LRKK2, AND GBA PATHOLOGIES LINKED TO PD, LBD AND MSA Date: April 4Time: 4:20 – 5:20 pm CETParticipant: Maria Maccecchini, Ph.D., Founder and CEO The AD/PD™ 2025 conference brings together the brightest minds in the field in order to share the latest breakthroughs in treatment, translational R&D, early diagnosis, drug development and clinical trials in AD, PD, and other related neurological disorders. About Annovis Headquartered in Malvern, Pennsylvania, Annovis is dedicated to addressing neurodegeneration in diseases such as AD and 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. Investor AlertsInterested investors and shareholders are encouraged to sign up for press releases and industry updates by registering for email alerts at https://www.annovisbio.com/email-alerts. Forward-Looking StatementsThis 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 DriveSuite 225Malvern, PA 19355www.annovisbio.com Investor Contact:Alexander Morin, Ph.D.Director, Strategic CommunicationsAnnovis Bioir@annovisbio.com

Phase 3

04 Feb 2025

·www.globenewswire.com

Annovis Bio, Inc. Announces Closing of $21 Million Public Offering

MALVERN, PA, Feb. 04, 2025 (GLOBE NEWSWIRE) -- via IBN - 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 closing of its previously announced underwritten public offering of 5,250,000 shares of common stock and warrants to purchase 5,250,000 shares of common stock at a combined public offering price of $4.00 per share and associated warrant. The warrants have an exercise price of $5.00 per share and are immediately exercisable upon issuance for a period of five years following the date of issuance. Total gross proceeds from the offering, before deducting the underwriter’s discounts and other offering expenses, were $21 million. The Company intends to use the net proceeds from the offering primarily for the continued clinical development of the Company’s lead compound, Buntanetap in a Phase 3 study for Alzheimer’s disease, and for working capital and general corporate purposes. ThinkEquity acted as the sole book-running manager for the offering. The securities were offered and sold pursuant to a shelf registration statement on Form S-3, as amended (File No. 333-276814), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the “SEC”) on February 1, 2024, and declared effective on February 12, 2024. The offering was made only by means of a written prospectus. A final prospectus supplement and accompanying prospectus describing the terms of the offering have been filed with the SEC on its website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained, when available, from the offices of ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About Annovis Bio, Inc. Headquartered in Malvern, Pennsylvania, Annovis is dedicated to addressing neurodegeneration in diseases such as AD and PD. The company’s innovative approach targets multiple neurotoxic proteins, aiming to restore brain function and improve the quality of life for patients. For more information, visit www.annovisbio.com and follow us on LinkedIn, YouTube, and X. Forward Looking StatementsThis press release contains “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, the Company’s plans related to clinical trials. Forward-looking statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Such risks and uncertainties include, but are not limited to, those related to patient enrollment, the effectiveness of Buntanetap, and the timing, effectiveness, and anticipated results of the Company’s clinical trials evaluating the efficacy, safety, and tolerability of Buntanetap. Additional risk factors are detailed in the Company’s periodic filings with the SEC, including those listed in the “Risk Factors” section of the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. All forward-looking statements in this press release are based on information available to the Company as of the date of this release. The Company expressly disclaims any obligation to update or revise its forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. Contact:Annovis Bio Inc. 101 Lindenwood Drive Suite 225 Malvern, PA 19355 www.annovisbio.com Investor Contact:Scott McGowanInvestorBrandNetwork (IBN)Phone: 310.299.1717www.annovisbio.com/investors-relationsIR@annovisbio.com

Phase 3

100 Deals associated with Buntanetap

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15317

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Alzheimer Disease	Phase 3	United States	Annovis Bio, Inc.	04 Feb 2025
Parkinson Disease	Phase 3	Spain	Annovis Bio, Inc.	03 Aug 2022
Parkinson Disease	Phase 3	Hungary	Annovis Bio, Inc.	03 Aug 2022
Parkinson Disease	Phase 3	United States	Annovis Bio, Inc.	03 Aug 2022
Parkinson Disease	Phase 3	Italy	Annovis Bio, Inc.	03 Aug 2022
Parkinson Disease	Phase 3	Poland	Annovis Bio, Inc.	03 Aug 2022
Parkinson Disease	Phase 3	Germany	Annovis Bio, Inc.	03 Aug 2022
Lewy Body Disease	Phase 2	-	Annovis Bio, Inc.	-
Young onset Parkinson disease	Preclinical	United States	Annovis Bio, Inc.	14 Aug 2020
Cognitive Dysfunction	Preclinical	United States	Annovis Bio, Inc.	26 May 2009

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05686044 (CTgov)	Phase 2/3	Alzheimer Disease	351	Placebo (Placebo)	oihobdnguq(ufshbwtkbz) = gzgxefffwa vljvqaahrn (bhsovahbor, fvfcoyzwqv - fjovzwgjwf) View more	-	29 Apr 2025
				Buntanetap/Posiphen (7.5mg Buntanetap/Posiphen)	oihobdnguq(ufshbwtkbz) = hxktjzkhwl vljvqaahrn (bhsovahbor, hhvqmzzrky - qhuwifbhgy) View more
NCT05357989 (CTgov)	Phase 3	Parkinson Disease	523	Placebo (Placebo)	jzrpfioetk(cpeygcvufr) = yzyabycdso luvlvqtafs (xnetskzuia, fxjailrinm - gnzeeunwdu) View more	-	03 Mar 2025
				buntanetap/posiphen (10 mg Buntanetap/Posiphen)	jzrpfioetk(cpeygcvufr) = sflszucssk luvlvqtafs (xnetskzuia, bhmtnmcbal - smvfqsqlso) View more
NCT05357989 (Biospace) Manual	Phase 3	Parkinson Disease	-	Buntanetap	(irtaidurjx) = In patients diagnosed with PD for longer than 3 years (MH>3), with measurable declines in MDS-UPDRS Part II, 20mg buntanetap significantly improved MDS-UPDRS Part II, Part III, Part II+III, and Total scores compared to placebo and baseline cuzlzpvfhb (dufsnsadns ) View more	Positive	02 Jul 2024
				Placebo
GlobeNewswire Manual	Not Applicable	Alzheimer Disease	-	Buntanetap 15mg	(jufjcdqnof) = ufpwhlzjtw ezyrlcpcxz (fwkagbfmxi )	Positive	11 Jun 2024
				Placebo	(jufjcdqnof) = lnggukbktf ezyrlcpcxz (fwkagbfmxi )
NCT05686044 (Biospace) Manual	Phase 2/3	Alzheimer Disease	325	Buntanetap 7.5 mg	(kdrjeuqxzm) = ggixydpfyk lmskirpvop (tqonokytbk, 0.87)	Positive	29 May 2024
				Buntanetap 15 mg	(kdrjeuqxzm) = xqrwetzjcx lmskirpvop (tqonokytbk, 0.81)
NCT05686044 (Biospace) Manual	Phase 2/3	Alzheimer Disease	107	Buntanetap	(dgjbwdlodu) = ntenlcmqtp frxribldhb (mkjpoffxxt )	Positive	30 Oct 2023
NCT04524351 (CTgov)	Phase 1/2	Young onset Parkinson disease \| Alzheimer Disease	75	Posiphen (Posiphen, 80mg (Parkinson's Participants))	rtwwyczjtu(pvakodewwn) = vguyfwutcd sefptquigl (ajtzbtqmfr, hfapmvajch - mitjvdspgt) View more	-	28 Feb 2023
				Posiphen (Posiphen, 40mg (Parkinson's Participants))	rtwwyczjtu(pvakodewwn) = nvokeukrai sefptquigl (ajtzbtqmfr, ribsvlnfyq - legydwmwwl) View more
NCT02925650 (CTAD2022)	Phase 1	Mild cognitive disorder CSF Aβ42/40	19	Posiphen	ihujelzucj(hmglvyibbq) = 8/19 participants reported headache either during CSF sampling (4),after the procedure (3), or both (1). 5 had blood patches with rapid resolution of headache. whxckyvfxi (lmepeeaipr )	-	03 Dec 2022

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