Interim Analysis of Buntanetap Phase 3 Trial Expected This Year

Trial's main goal is to see if 450 participants is enough

Lindsey Shapiro, PhD avatar

by Lindsey Shapiro, PhD |

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Annovis Bio anticipates an interim data analysis from a Phase 3 trial of its therapeutic candidate buntanetap in people with early-stage Parkinson’s disease will be possible by mid-year, based on current trial enrollment.

By then, there will likely be enough patients who’ll have received at least two months of daily treatment in the Phase 3 clinical trial (NCT05357989) to conduct an analysis. The main goal of the analysis is to see if the planned enrollment of about 450 people is sufficient for a statistically significant effect after six months.

The plan is to place about 150 Parkinson’s patients in each of three study arms: 10 mg of buntanetap, 20 mg of buntanetap, and a placebo. That number can be increased or decreased by about 25% per arm, or between 112–200 patients, based on the analysis outcome.

If the treatment is more effective than expected, fewer participants will be needed, whereas if it’s less effective, more patients may be needed. The results may also confirm that the planned 450 participants remain the optimal target.

Recruitment is ongoing at numerous sites in the U.S.

“We are very pleased with the pace of enrollment in our Phase 3 study, which is designed to assess the safety and efficacy of buntanetap in early-stage Parkinson’s patients,” said Maria L. Maccecchini, PhD, founder, president, and CEO of Annovis, in a company press release. “We look forward to providing an interim data analysis from the study in the second quarter of 2023, which will enable us to optimize our patient enrollment for the study.”

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Buntanetap (previously known as ANVS401 or posiphen) is a small oral molecule that suppresses the production of several proteins that form toxic clumps in neurodegenerative diseases. These include the alpha-synuclein protein that builds up in Parkinson’s as well as beta-amyloid and tau proteins in Alzheimer’s disease.

“Buntanetap is a highly differentiated and potentially groundbreaking therapy,” Maccecchini said.

A previous Phase 2a trial (NCT04524351) that included people with early Parkinson’s and Alzheimer’s found buntanetap safe at various doses, once daily for 25 days.

It was also superior to a placebo at improving cognitive and motor skills in Parkinson’s patients. Researchers determined 10 or 20 mg offered the best overall clinical benefit, leading to significant reductions in disease severity, as assessed by the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS).

Buntanetap also reportedly lowered toxic protein levels, improved nerve cell integrity and communication, and reduced inflammation in Parkinson’s patients.

These findings supported launching the Phase 3 trial, which started dosing patients last August. It’s designed to test buntanetap against a placebo in early-stage Parkinson’s patients, ages 40 to 85.

Participants will be randomly assigned to receive either daily 10 or 20 mg of buntanetap or a placebo on top of their standard of care medications, for up to six months.

Along with safety and tolerability, the trial’s primary goal is to assess changes in MDS-UPDRS part 2 and 3 scores. Part 2 measures the ability to perform daily living activities, while part 3 assesses motor function.

Secondary goals include changes in total MDS-UPDRS scores and Participant Global Impression of Change, a measure of patients’ perspectives on treatment effectiveness. Changes in cognitive function and blood biomarkers will also be assessed in an exploratory manner.

Annovis previously noted plans to launch a second Phase 3 trial of buntanetap in late-stage Parkinson’s patients, for which the U.S. Food and Drug Administration provided positive feedback.