Trial Outcomes & Findings for A Double-blind Study to Investigate Efficacy and Safety of Buntanetap Compared With Placebo in Participants With Early PD (NCT NCT05357989)

Last Updated: 2025-03-03

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

523 participants

Primary outcome timeframe

Baseline and 6 months visits

Results posted on

2025-03-03

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Placebo oral capsule with daily administration for a period of 6 months	10 mg Buntanetap/Posiphen Buntanetap/posiphen 10 mg oral capsule with daily administration for a period of 6 months	20 mg Buntanetap/Posiphen Buntanetap/posiphen 20 mg oral capsule with daily administration for a period of 6 months
Overall Study STARTED	176	174	173
Overall Study COMPLETED	162	159	150
Overall Study NOT COMPLETED	14	15	23

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Not all participants completed the MMSE at Baseline.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=176 Participants Placebo oral capsule with daily administration for a period of 6 months	10 mg Buntanetap/Posiphen n=174 Participants Buntanetap/posiphen 10 mg oral capsule with daily administration for a period of 6 months	20 mg Buntanetap/Posiphen n=173 Participants Buntanetap/posiphen 20 mg oral capsule with daily administration for a period of 6 months	Total n=523 Participants Total of all reporting groups
Age, Continuous	65.4 years STANDARD_DEVIATION 8.88 • n=176 Participants	65.0 years STANDARD_DEVIATION 8.85 • n=174 Participants	65.4 years STANDARD_DEVIATION 10.09 • n=173 Participants	65.2 years STANDARD_DEVIATION 9.27 • n=523 Participants
Sex: Female, Male Female	65 Participants n=176 Participants	54 Participants n=174 Participants	55 Participants n=173 Participants	174 Participants n=523 Participants
Sex: Female, Male Male	111 Participants n=176 Participants	120 Participants n=174 Participants	118 Participants n=173 Participants	349 Participants n=523 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	30 Participants n=176 Participants	21 Participants n=174 Participants	31 Participants n=173 Participants	82 Participants n=523 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	146 Participants n=176 Participants	152 Participants n=174 Participants	141 Participants n=173 Participants	439 Participants n=523 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=176 Participants	1 Participants n=174 Participants	1 Participants n=173 Participants	2 Participants n=523 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=176 Participants	0 Participants n=174 Participants	1 Participants n=173 Participants	1 Participants n=523 Participants
Race (NIH/OMB) Asian	4 Participants n=176 Participants	4 Participants n=174 Participants	3 Participants n=173 Participants	11 Participants n=523 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=176 Participants	0 Participants n=174 Participants	0 Participants n=173 Participants	0 Participants n=523 Participants
Race (NIH/OMB) Black or African American	4 Participants n=176 Participants	6 Participants n=174 Participants	3 Participants n=173 Participants	13 Participants n=523 Participants
Race (NIH/OMB) White	167 Participants n=176 Participants	163 Participants n=174 Participants	166 Participants n=173 Participants	496 Participants n=523 Participants
Race (NIH/OMB) More than one race	0 Participants n=176 Participants	1 Participants n=174 Participants	0 Participants n=173 Participants	1 Participants n=523 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=176 Participants	0 Participants n=174 Participants	0 Participants n=173 Participants	1 Participants n=523 Participants
Mini-Mental State Examination (MMSE)	28.7 units on a scale STANDARD_DEVIATION 1.71 • n=173 Participants • Not all participants completed the MMSE at Baseline.	28.7 units on a scale STANDARD_DEVIATION 1.70 • n=173 Participants • Not all participants completed the MMSE at Baseline.	28.3 units on a scale STANDARD_DEVIATION 2.12 • n=171 Participants • Not all participants completed the MMSE at Baseline.	28.6 units on a scale STANDARD_DEVIATION 1.86 • n=517 Participants • Not all participants completed the MMSE at Baseline.

PRIMARY outcome

Timeframe: Baseline and 6 months visits

Population: Participants with MDS-UPDRS Part II scores at Baseline and 6 months (intent-to-treat population)

Outcome measures

Outcome measures
Measure	Placebo n=160 Participants Placebo oral capsule with daily administration for a period of 6 months	10 mg Buntanetap/Posiphen n=160 Participants Buntanetap/posiphen 10 mg oral capsule with daily administration for a period of 6 months	20 mg Buntanetap/Posiphen n=152 Participants Buntanetap/posiphen 20 mg oral capsule with daily administration for a period of 6 months
Change From Baseline to Month 6 in MDS-UPDRS Part II (OFF-state)	-0.10 units on a scale Standard Error 0.311	0.57 units on a scale Standard Error 0.312	-0.04 units on a scale Standard Error 0.319

SECONDARY outcome

Timeframe: Baseline and 6 months visits

Population: Participants with MDS-UPDRS Part III scores at Baseline and 6 months (intent-to-treat population)

MDS-UPDRS Part III (motor examination) has 18 items and ranges from 0-132, with higher scores reflecting greater severity.

Outcome measures

Outcome measures
Measure	Placebo n=160 Participants Placebo oral capsule with daily administration for a period of 6 months	10 mg Buntanetap/Posiphen n=160 Participants Buntanetap/posiphen 10 mg oral capsule with daily administration for a period of 6 months	20 mg Buntanetap/Posiphen n=153 Participants Buntanetap/posiphen 20 mg oral capsule with daily administration for a period of 6 months
Change From Baseline to Month 6 in the MDS-UPDRS Part III (OFF-state)	-2.90 units on a scale Standard Error 0.698	-1.04 units on a scale Standard Error 0.697	-2.66 units on a scale Standard Error 0.713

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 6 months visits

Population: Participants with MMSE scores at Baseline and 6 months (intent-to-treat population)

Change in the MMSE score from Baseline to the End of Trial. MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures). Total score ranges from 0 to 30 with a lower score indicating greater disease severity.

Outcome measures

Outcome measures
Measure	Placebo n=159 Participants Placebo oral capsule with daily administration for a period of 6 months	10 mg Buntanetap/Posiphen n=159 Participants Buntanetap/posiphen 10 mg oral capsule with daily administration for a period of 6 months	20 mg Buntanetap/Posiphen n=152 Participants Buntanetap/posiphen 20 mg oral capsule with daily administration for a period of 6 months
Change From Baseline to Month 6 in MMSE (OFF-state)	-0.39 units on a scale Standard Error 0.123	-0.08 units on a scale Standard Error 0.123	-0.05 units on a scale Standard Error 0.126

POST_HOC outcome

Timeframe: Baseline and 6 months visits

Population: Participants with MMSE scores at Baseline and 6 months

Outcome measures

Outcome measures
Measure	Placebo n=49 Participants Placebo oral capsule with daily administration for a period of 6 months	10 mg Buntanetap/Posiphen n=50 Participants Buntanetap/posiphen 10 mg oral capsule with daily administration for a period of 6 months	20 mg Buntanetap/Posiphen n=54 Participants Buntanetap/posiphen 20 mg oral capsule with daily administration for a period of 6 months
Change From Baseline to Month 6 in MMSE (OFF-state) for Participants With Baseline MMSE Scores 20-28	-0.50 units on a scale Standard Error 0.317	0.65 units on a scale Standard Error 0.313	0.45 units on a scale Standard Error 0.301

Adverse Events

Placebo

Serious events: 5 serious events

Other events: 20 other events

Deaths: 0 deaths

10 mg Buntanetap/Posiphen

Serious events: 4 serious events

Other events: 15 other events

Deaths: 1 deaths

20 mg Buntanetap/Posiphen

Serious events: 11 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo n=176 participants at risk Placebo oral capsule with daily administration for a period of 6 months	10 mg Buntanetap/Posiphen n=174 participants at risk Buntanetap/posiphen 10 mg oral capsule with daily administration for a period of 6 months	20 mg Buntanetap/Posiphen n=173 participants at risk Buntanetap/posiphen 20 mg oral capsule with daily administration for a period of 6 months
Infections and infestations Covid-19	5.7% 10/176 • Number of events 10 • From consent to end of trial (up to 8 months)	2.9% 5/174 • Number of events 5 • From consent to end of trial (up to 8 months)	2.3% 4/173 • Number of events 4 • From consent to end of trial (up to 8 months)
Gastrointestinal disorders Nausea	2.8% 5/176 • Number of events 5 • From consent to end of trial (up to 8 months)	2.9% 5/174 • Number of events 5 • From consent to end of trial (up to 8 months)	6.4% 11/173 • Number of events 14 • From consent to end of trial (up to 8 months)
General disorders Fatigue	2.8% 5/176 • Number of events 5 • From consent to end of trial (up to 8 months)	2.9% 5/174 • Number of events 6 • From consent to end of trial (up to 8 months)	5.2% 9/173 • Number of events 9 • From consent to end of trial (up to 8 months)

Additional Information

Matthew Peterson, PhD

Annovis Bio, Inc.

Phone: 484-875-3192

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Annovis Bio's agreements with its investigators may vary. However, Annovis Bio does not prohibit any investigator from publishing. Any publications from a single site are postponed until the publication of the pooled data for a clinical trial or for 12 months.
Publication restrictions are in place

Restriction type: OTHER

Measure	Placebo n=176 participants at risk Placebo oral capsule with daily administration for a period of 6 months	10 mg Buntanetap/Posiphen n=174 participants at risk Buntanetap/posiphen 10 mg oral capsule with daily administration for a period of 6 months	20 mg Buntanetap/Posiphen n=173 participants at risk Buntanetap/posiphen 20 mg oral capsule with daily administration for a period of 6 months
Cardiac disorders Myocardial Infarction	0.00% 0/176 • From consent to end of trial (up to 8 months)	1.1% 2/174 • Number of events 2 • From consent to end of trial (up to 8 months)	0.00% 0/173 • From consent to end of trial (up to 8 months)
Cardiac disorders Angina Pectoris	0.00% 0/176 • From consent to end of trial (up to 8 months)	0.00% 0/174 • From consent to end of trial (up to 8 months)	0.58% 1/173 • Number of events 1 • From consent to end of trial (up to 8 months)
Cardiac disorders Myocardial Ischaemia	0.00% 0/176 • From consent to end of trial (up to 8 months)	0.00% 0/174 • From consent to end of trial (up to 8 months)	0.58% 1/173 • Number of events 1 • From consent to end of trial (up to 8 months)
Gastrointestinal disorders Gastritis	0.00% 0/176 • From consent to end of trial (up to 8 months)	0.57% 1/174 • Number of events 1 • From consent to end of trial (up to 8 months)	0.00% 0/173 • From consent to end of trial (up to 8 months)
Gastrointestinal disorders Enterocolitis	0.57% 1/176 • Number of events 1 • From consent to end of trial (up to 8 months)	0.00% 0/174 • From consent to end of trial (up to 8 months)	0.00% 0/173 • From consent to end of trial (up to 8 months)
Gastrointestinal disorders Upper Gastrointestinal Haemorrhage	0.57% 1/176 • Number of events 1 • From consent to end of trial (up to 8 months)	0.00% 0/174 • From consent to end of trial (up to 8 months)	0.00% 0/173 • From consent to end of trial (up to 8 months)
Injury, poisoning and procedural complications Accidental Overdose	0.00% 0/176 • From consent to end of trial (up to 8 months)	0.00% 0/174 • From consent to end of trial (up to 8 months)	0.58% 1/173 • Number of events 1 • From consent to end of trial (up to 8 months)
Injury, poisoning and procedural complications Contusion	0.00% 0/176 • From consent to end of trial (up to 8 months)	0.00% 0/174 • From consent to end of trial (up to 8 months)	0.58% 1/173 • Number of events 1 • From consent to end of trial (up to 8 months)
Injury, poisoning and procedural complications Hip Fracture	0.00% 0/176 • From consent to end of trial (up to 8 months)	0.00% 0/174 • From consent to end of trial (up to 8 months)	0.58% 1/173 • Number of events 1 • From consent to end of trial (up to 8 months)
Infections and infestations Diverticulitis	0.00% 0/176 • From consent to end of trial (up to 8 months)	0.57% 1/174 • Number of events 1 • From consent to end of trial (up to 8 months)	0.00% 0/173 • From consent to end of trial (up to 8 months)
Infections and infestations Gastroenteritis	0.00% 0/176 • From consent to end of trial (up to 8 months)	0.00% 0/174 • From consent to end of trial (up to 8 months)	0.58% 1/173 • Number of events 1 • From consent to end of trial (up to 8 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer	0.00% 0/176 • From consent to end of trial (up to 8 months)	0.00% 0/174 • From consent to end of trial (up to 8 months)	0.58% 1/173 • Number of events 1 • From consent to end of trial (up to 8 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	0.00% 0/176 • From consent to end of trial (up to 8 months)	0.00% 0/174 • From consent to end of trial (up to 8 months)	0.58% 1/173 • Number of events 1 • From consent to end of trial (up to 8 months)
Nervous system disorders Syncope	0.57% 1/176 • Number of events 1 • From consent to end of trial (up to 8 months)	0.00% 0/174 • From consent to end of trial (up to 8 months)	0.00% 0/173 • From consent to end of trial (up to 8 months)
Nervous system disorders Toxic Encephalopathy	0.00% 0/176 • From consent to end of trial (up to 8 months)	0.00% 0/174 • From consent to end of trial (up to 8 months)	0.58% 1/173 • Number of events 1 • From consent to end of trial (up to 8 months)
Endocrine disorders Addison's Disease	0.57% 1/176 • Number of events 1 • From consent to end of trial (up to 8 months)	0.00% 0/174 • From consent to end of trial (up to 8 months)	0.00% 0/173 • From consent to end of trial (up to 8 months)
General disorders Chest Pain	0.00% 0/176 • From consent to end of trial (up to 8 months)	0.00% 0/174 • From consent to end of trial (up to 8 months)	0.58% 1/173 • Number of events 1 • From consent to end of trial (up to 8 months)
Hepatobiliary disorders Cholecystitis Acute	0.00% 0/176 • From consent to end of trial (up to 8 months)	0.00% 0/174 • From consent to end of trial (up to 8 months)	0.58% 1/173 • Number of events 1 • From consent to end of trial (up to 8 months)
Musculoskeletal and connective tissue disorders Back Pain	0.57% 1/176 • Number of events 1 • From consent to end of trial (up to 8 months)	0.00% 0/174 • From consent to end of trial (up to 8 months)	0.00% 0/173 • From consent to end of trial (up to 8 months)
Vascular disorders Hypertension	0.00% 0/176 • From consent to end of trial (up to 8 months)	0.00% 0/174 • From consent to end of trial (up to 8 months)	0.58% 1/173 • Number of events 1 • From consent to end of trial (up to 8 months)