Trial of buntanetap for early-stage Parkinson’s nears end

Last patient completes final visit in Phase 3 clinical trial of buntanetap

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by Andrea Lobo |

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Annovis Bio has announced the last patient completed the final visit in its Phase 3 clinical trial testing buntanetap for people with early-stage Parkinson’s disease.

Since the study was initiated in August 2022, more than 616 patients were screened, 523 enrolled, and 471 completed the study across 67 sites (43 in the U.S. and 24 in five countries of the European Union).

Topline data from this Phase 3 clinical trial (NCT05357989), assessing buntanetap’s safety, tolerability, and efficacy, are expected in January 2024.

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“We are pleased to share the completion of our Parkinson’s study which marks a significant step forward in our ongoing mission to bring new therapies for those affected by this challenging neurodegenerative disease,” Maria Maccecchini, PhD, Annovis Bio’s founder, president, and CEO, said in a company press release.

Buntanetap, previously known as ANVS401 or posiphen, is an experimental oral therapy that works by reducing the levels of proteins that build up into toxic clumps, such as alpha-synuclein in Parkinson’s and beta-amyloid and tau in Alzheimer’s disease. It does so by blocking translation, which is the cellular process of producing proteins according to DNA instructions.

By preventing the buildup of protein clumps, the therapy improves synaptic transmission and axonal transport — key biological processes required for nerve cells to transmit information — identified as contributing factors for nerve cell degeneration and death.

In this Phase 3 trial patients with early-stage Parkinson’s, ages 40 to 85, were assigned randomly to receive one capsule of either 10 or 20 mg of buntanetap, or a placebo, once daily for six months. The treatment was given in addition to each patient’s standard care.

Primary and secondary goals of the buntanetap study

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. Safety and tolerability also are primary goals.

Secondary goals include total MDS-UPDRS scores and Participant Global Impression of Change (PGIC), a measure of patients’ views of the treatment’s effectiveness.

“Our team now shifts its focus to diligently cleaning and analyzing the data to meet our goal of sharing the topline results early next year,” said Melissa Gaines, the company’s senior vice president of clinical operations.

According to the company, the large number of patients enrolled and the low dropout rate (9.9%) may be related to the treatment’s safety and tolerability, and the convenience of taking just one pill per day. Other reasons include the positive outcomes during a previous Phase 1/2 trial (NCT04524351).

This trial, which included people with early Parkinson’s and Alzheimer’s, demonstrated that buntanetap was safe when given once daily for 25 days, and improved the cognitive and motor skills of people with Parkinson’s.

Reduced levels of TDP-43 protein

Recently, the company has shown that buntanetp significantly reduced the blood levels of the protein TDP-43 in people with Parkinson’s who participated in this Phase 2 trial. When this protein is highly active, it builds up into toxic clumps, just like alpha-synuclein, impairing nerve cell function and contributing to neuronal death.

The company is planning a similar Phase 3 trial in patients with late-stage Parkinson’s disease, for which the U.S. Food and Drug Administration (FDA) also gave positive feedback in 2022.