Enrollment complete in Phase 3 trial of buntanetap for Parkinson’s

Therapy aims to improve cognitive, motor skills in early-stage disease

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by Andrea Lobo |

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Enrollment is now complete for a Phase 3 trial of buntanetap, an oral therapy candidate from Annovis Bio that aims to improve cognitive and motor skills in early-stage Parkinson’s disease, the company has announced.

Since the first participant was dosed in August 2022, more than 640 patients were screened and 520 enrolled at 67 sites – 43 in the U.S. and 24 in the European Union. Full enrollment was reached nine months after recruiting started.

The trial is expected to be concluded by November, with top-line data available by the end of the year.

“The Parkinson’s community is extremely well-informed and connected,” Maria Maccecchini, PhD, founder, president, and CEO of Annovis, said in a press release.

“When they learned of our innovative and patient-focused approach showing early therapeutic potential they wanted to be involved in making an impact,” Maccecchini said, noting also the possible benefits for other neurodegenerative diseases.

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Buntanetap aims to treat both early-stage and late-stage Parkinson’s

Buntanetap, previously known as ANVS401 or posiphen, works by reducing the levels of harmful protein clumps in conditions like Parkinson’s and Alzheimer’s disease. These clumps are made up of proteins such as alpha-synuclein in Parkinson’s and beta-amyloid and tau in Alzheimer’s.

The experimental therapy achieves its effects by blocking translation, the cellular process responsible for creating proteins according to DNA instructions. Consequently, it improves synaptic transmission and axonal transport, the crucial pathways within nerve cells responsible for transmitting information, which have been identified as the underlying cause of nerve cell degeneration and eventual death.

In this Phase 3 clinical trial (NCT05357989), patients with early-stage Parkinson’s, ages 40 to 85, are randomly assigned to receive either buntanetap or a placebo once daily for up to six months. Treatments — with buntanetap administered at doses of 10 or 20 mg — are given on top of each patient’s standard of care. Neither participants nor researchers know which patients are receiving the therapy and which the placebo.

The study’s main goal is to assess changes in MDS-UPDRS part II and III scores, which evaluate activities of daily living and motor function, over six months of treatment. It also aims to assess buntanetap’s safety and tolerability.

Secondary goals include total MDS-UPDRS scores and Participant Global Impression of Change (PGIC), which considers patient views of treatment efficacy.

The trial was approved by the U.S. Food and Drug Administration (FDA) in July 2022. The company also is planning a similar trial involving patients with late-stage Parkinson’s, for which the FDA gave positive feedback earlier this year.

According to the Annovis Bio, the large number of enrolled participants and low rate of dropout can be attributed to several factors. These include positive outcomes in body and motor function during a Phase 1/2 trial (NCT04524351), the convenience of taking just one pill per day, and buntanetap’s overall safety and tolerability.