A Double-blind Study to Investigate Efficacy and Safety of Buntanetap Compared With Placebo in Participants With Early PD

NCT05357989 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: ANVS-22001
• Study Type: interventional
• Target: 523
• Locations: 6 countries
• Sites: 69

Brief Summary

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

Conditions

Parkinson's Disease, Idiopathic

Keywords

Parkinson's

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Month 6 in MDS-UPDRS Part II (OFF-state)

  Change in the Score from the MDS- Unified Parkinson's Disease Rating Scale (UPDRS) Parts II from Baseline to the End of Trial. MDS-UPDRS Part II (Motor experiences of daily living) has 13 items and the score ranges from 0-52, with higher scores reflecting greater severity.

  Baseline and 6 months visits

Secondary Outcomes (1)

• Change From Baseline to Month 6 in the MDS-UPDRS Part III (OFF-state)

  Baseline and 6 months visits

Other Outcomes (1)

• Change From Baseline to Month 6 in MMSE (OFF-state)

  Baseline and 6 months visits

Study Arms (3)

10 mg buntanetap/posiphen

EXPERIMENTAL

Buntanetap/posiphen 10 mg oral capsule with daily administration for a period of 6 months

Drug: buntanetap/posiphen

20 mg buntanetap/posiphen

EXPERIMENTAL

Buntanetap/posiphen 20 mg oral capsule with daily administration for a period of 6 months

Drug: buntanetap/posiphen

Placebo

PLACEBO COMPARATOR

Placebo oral capsule with daily administration for a period of 6 months

Drug: Placebo

Interventions

buntanetap/posiphen DRUG

HPMC (vegetarian source) capsule shells

Also known as: Posiphen Tartrate, ANVS401

10 mg buntanetap/posiphen; 20 mg buntanetap/posiphen

Placebo DRUG

HPMC (vegetarian source) capsule shells

Placebo

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of idiopathic Parkinson Disease according to MDS Clinical Diagnostic Criteria for Parkinson's Disease.
• H\&Y score =1, 2 or 3 during ON-state \& OFF-state \<2hrs per day.
• Male or female aged 40 - 85 years.
• MMSE score between the range of 22-30 during screening visit (ON-state) and subjects can live independently without a caregiver.
• Female subjects of childbearing potential\* must have a negative serum or urine pregnancy test at Screening, must be non-lactating and must agree to use a highly effective method of contraception (i.e., a method resulting in a failure rate of less than 1% per year when used consistently and correctly) during the trial and for 4 weeks after the last dose of trial treatment, such as:
• Oral, intravaginal, or transdermal combined (estrogen plus progestogen) hormonal contraception associated with inhibition of ovulation
• Oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation
• Intrauterine device (IUD)
• Intrauterine hormone-releasing system (IUS)
• Bilateral tubal occlusion
• Vasectomized partner (a vasectomized partner is a highly effective contraception method provided that the partner is the sole male sexual partner of the participant, and the absence of sperm has been confirmed. If not, an additional highly effective method of contraception should be used)
• Sexual abstinence (sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatment. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant) \*Non-childbearing potential includes surgically sterilized or postmenopausal with no menstrual bleeding for at least one year prior to study start.
• Male subjects must be sterile or sexually inactive or agree not to father a child during the study and one month after the last dose of study medication and must agree to use a barrier method for contraception. Female partners of male subject must adopt a highly effective method of contraception with a failure rate of less than 1% per year when used consistently and correctly such as:
• Oral, intravaginal, or transdermal combined (estrogen plus progestogen) hormonal contraception associated with inhibition of ovulation
• Oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation

You may not qualify if:

• Has a history of a psychiatric disorder such as schizophrenia, bipolar disorder or major depression according to the criteria of the most current version of the Diagnostic and Statistical Manual of Mental Disorders (DSM). Mild depression or history of depression that is stable on treatment with a selective serotonin reuptake inhibitor (SSRI) or selective norepinephrine reuptake inhibitor (SNRI) medication at a stable dose is acceptable.
• History of a seizure disorder, if stable on medication is acceptable.
• Has a history or current evidence of long QT syndrome, Fridericia's formula corrected QT (QTcF) interval ≥ 475ms, or torsades de pointes.
• Has bradycardia (\<50 bpm) or tachycardia (\>100 bpm) on the ECG at screening.
• Has uncontrolled Type-1 or Type-2 diabetes. A subject with HbA1c levels up to 7.5% can be enrolled if the investigator believes the subject's diabetes is under control.
• Has clinically significant renal or hepatic impairment.
• Has any clinically significant abnormal laboratory values. Subjects with liver function tests (aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\]) greater than twice the upper limit of normal will be excluded.
• Is at imminent risk of self-harm, based on clinical interview and responses on the C SSRS, or of harm to others in the opinion of the Investigators. Subjects must be excluded if they report suicidal ideation with intent, with or without a plan or method (e. g. positive response to Items 4 or 5 in assessment of suicidal ideation on the C SSRS) in the past 2 months, or suicidal behavior in the past 6 months.
• Has cancer or has had a malignant tumor within the past year, except subjects who underwent potentially curative therapy with no evidence of recurrence. (Subjects with stable untreated prostate cancer or skin cancers are not excluded).
• Alcohol / Substance use disorder, moderate to severe, in the last 5 years according to the most current version DSM.
• Participation in another clinical trial with an investigational agent and have taken at least one dose of study medication, unless unblinded on placebo, within 60 days prior to the start of screening. The end of a previous investigational trial is the date the last dose of an investigational agent was taken, or five half-lives of the investigational drug, whichever is greater.
• Subjects with learning disability or developmental delay.
• Subjects whom the site PI deems to be otherwise ineligible.
• Subjects with a known allergy to the investigational drug or any of its components.
• Subject is currently pregnant, breast-feeding and/or lactating.

Sponsors & Collaborators

• Annovis Bio Inc.: lead
• TFS Trial Form Support: collaborator

Study Sites (69)

University of Alabama at Birmingham (UAB)- The Kirklin Clinic

Birmingham, Alabama, 35233-2110, United States

Location

Banner Sun Health Research Institute - Cleo Roberts Center for Clinical Research

Sun City, Arizona, 85351-3020, United States

Location

Parkinson's & Movement Disorder Institue (PMDI) - Orange County Office

Fountain Valley, California, 92708, United States

Location

UCSF Medical Center - Parkinson's Disease and Movement Disorders Clinic

San Francisco, California, 94143-2202, United States

Location

Rocky Mountain Movement Disorder Center

Englewood, Colorado, 80113, United States

Location

Ki Health Partners LLC D/B/A New England Institute for Clinical Research

Stamford, Connecticut, 06824, United States

Location

Visionary Investigators Network

Aventura, Florida, 33180, United States

Location

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, 33486-2359, United States

Location

The Neurology Institute - Coral Springs

Coral Springs, Florida, 33067-4640, United States

Location

Arrow Clinical trial

Daytona Beach, Florida, 32114, United States

Location

Accel Research Sites - DeLand Clinical Research Unit

DeLand, Florida, 32720, United States

Location

Coral Clinic Reserach LLC

Homestead, Florida, 33032, United States

Location

Homestead Associates in Research, Inc

Miami, Florida, 33032, United States

Location

Visionary Investigators Networks

Miami, Florida, 33133, United States

Location

Medical Professional Clinical Research Center, INC

Miami, Florida, 33165, United States

Location

Reliant Medical Research

Miami, Florida, 33165, United States

Location

Ezy Medical Research Co.

Miami, Florida, 33175, United States

Location

Visionary Investigators Network

Miami, Florida, 33176, United States

Location

Renstar Medical Research

Ocala, Florida, 34470, United States

Location

Visionary Investigators Network

Pembroke Pines, Florida, 33026, United States

Location

Parkinsons Disease Treatment Center

Port Charlotte, Florida, 33952-6705, United States

Location

University of South Florida (USF) - University of South Florida College of Medicine- Parkinson's Disease and Movement Disorders Center

Tampa, Florida, 33613-4808, United States

Location

ClinCloud, LLC

Viera, Florida, 32940, United States

Location

Conquest Research, LLC

Winter Park, Florida, 32789, United States

Location

CenExel iResearch, LLC

Decatur, Georgia, 30030, United States

Location

Hawaii Pacific Neuroscience, LLC

Honolulu, Hawaii, 96817, United States

Location

Josephson Wallack Munshower Neurology, P.C.

Indianapolis, Indiana, 46256, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Michigan State University (MSU)- Health Team- Neurology and Ophthalmology Clinic

East Lansing, Michigan, 48824-7037, United States

Location

Quest Research Institue

Farmington Hills, Michigan, 48334, United States

Location

Parkinson's Disease and Movement Disorders Center of Long Island

Commack, New York, 11725-3400, United States

Location

Mount Sinai West (Mount Sinai Roosevelt)

New York, New York, 10019-1147, United States

Location

Ohio State University Wexner Medical Center (OSUWMC) - CarePoint Gahanna

Columbus, Ohio, 43211, United States

Location

The Movement Disorder Clinic (MDC) of Oklahoma

Tulsa, Oklahoma, 74136-6372, United States

Location

Abington Neurology

Abington, Pennsylvania, 19001, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19107, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Medical University of South Carolina (MUSC) - The Murray Center for Research on Parkinson's Disease and Related Disorders

Charleston, South Carolina, 29401-1189, United States

Location

Veracity Neuroscience, LLC

Memphis, Tennessee, 38157, United States

Location

Central Texas Neurology Consultants

Round Rock, Texas, 78681, United States

Location

University of Virginia Health System (UVAHS)- Adult Neurology Clinic

Charlottesville, Virginia, 22903, United States

Location

Inland Northwest Research

Spokane, Washington, 99202-1342, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Curiositas-ad-sanum GmbH

Haag, Bavaria, 83527, Germany

Location

Kliniken Beelitz GmbH - Neurologisches Frachkrankenhaus fur Bewegungsstoerungen / Parkinson

Beelitz, Brandenburg, 14547, Germany

Location

Paracelsus-Kliniken Deutschland GmbH & Co. KGaA - Paracelsus-Elena-Klinik Kassel

Kassel, Hesse, 34128, Germany

Location

University Hospital Muenster

Münster, North Rhine-Westphalia, 48149, Germany

Location

Klinik und Poliklinik fur Neurologie - Universitatsklinikum Carl Gustav Carus an der Techischen Universitat

Dresden, Saxony, 01307, Germany

Location

Neurologie Berlin - Gemeinschaftspraxis Dr. Ehret / Dr. von Pannwitz

Berlin, 12163, Germany

Location

Alexianer St. Joseph-Krankenhaus Berlin-Weissensee

Berlin, 13088, Germany

Location

Debreceni Egyetem Klinikai Központ Neurológiai Klinika (Kenézy Gyula Campus, Neurológiai Osztály)

Debrecen, H-4032, Hungary

Location

PTE AOK Neurologiai Klinika

Pécs, H-7623, Hungary

Location

Universita degli Studi di Salerno - Centro per le Malattie Neurodegenerative

Baronissi, Campania, 84081, Italy

Location

San Raffaele Cassino - Centro di Cura e Prevenzione per il Parkinson

Cassino, Lazio, 3043, Italy

Location

San Raffaele Pisana - Centro per la Cura e la Diagnosi del Parkinson

Rome, Lazio, 163, Italy

Location

Pratia MCM Krakow

Krakow, Lesser Poland Voivodeship, 30-727, Poland

Location

Unicardia Specjalstyczne Centrum Leczenia Chorob Serca I Naczyn&Unimedica Specjalistyczne Centrum Medyczne

Krakow, Lesser Poland Voivodeship, 31-271, Poland

Location

Krakowska Akademia Neurologil Sp. z o.o. - Centrum Neurologii Klinicznej

Krakow, Lesser Poland Voivodeship, 31-505, Poland

Location

RCMed Oddzial Sochaczew

Sochaczew, Masovian Voivodeship, 96-500, Poland

Location

MTZ Clinical Research Powered by Pratia

Warsaw, Masovian Voivodeship, 02-172, Poland

Location

Specjalistyczna Praktyka Lekarska Dr. Stanislaw Ochudlo

Katowice, Silesian Voivodeship, 40-097, Poland

Location

NEURO-CARE Sp. z o.o. Sp. Komandytowa

Siemianowice Śląskie, Silesian Voivodeship, 41-100, Poland

Location

Hospital General Universitario de Elche

Elche, Alicante, 03203, Spain

Location

Hospital Universitaris General de Catalunya (HGC)

Sant Cugat del Vallès, Barcelona, 8195, Spain

Location

Policlinica Gipuzkoa - Centro de Invesigacion Parkinson (CIP)

Donostia / San Sebastian, Gipuzkoa, 20014, Spain

Location

Universidad Complutense de Madrid (UCM) - Hospital Universitario Infanta Sofia

San Sebastián de los Reyes, Madrid, 28701, Spain

Location

Universidad de Navarra - Clnica Universidad de Navarra (CUN) - Pamplona

Pamplona, Navarre, 31008, Spain

Location

Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Madrid

Madrid, 28027, Spain

Location

Hospital Universitario Virgen del Rocio (URVR - Instituto de Biomedicina de Sevilla (IBIS)

Seville, 41015, Spain

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

phenserine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Matthew Peterson, PhD
• Organization: Annovis Bio, Inc.

peterson@annovisbio.com

484-875-3192

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: May 3, 2022
• Study Start: August 3, 2022
• Primary Completion: December 4, 2023
• Study Completion: December 4, 2023
• Last Updated: March 3, 2025
• Results First Posted: March 3, 2025

Record last verified: 2025-02

Locations

PL (7); ES (7); IT (3); US (43); DE (7); HU (2)