FDA to hear plan for buntanetap as Parkinson’s dementia treatment
Annovis says January meeting will include talks on clinical trial design
- Annovis Bio will meet with the FDA on buntanetap for Parkinson's dementia.
- Buntanetap aims to reduce production of toxic protein clumps in brain cells.
- The drug showed promise in earlier trials for Parkinson's and Alzheimer's.
Annovis Bio has scheduled a January meeting with the U.S. Food and Drug Administration (FDA) to discuss buntanetap as a treatment for dementia due to Parkinson’s disease.
The meeting will include discussions about potential clinical trial design, the criteria that will be used to determine which patients to enroll, and the data required to support an application seeking approval of buntanetap for Parkinson’s dementia.
“We are pleased with such proactive engagement with the FDA on our [Parkinson’s disease dementia] program, which represents a significant opportunity to address an underserved patient population,” Maria Maccecchini, PhD, Annovis’ president and CEO, said in a company press release. “The scheduled January meeting marks a key milestone for our pipeline, underscoring buntanetap’s potential across multiple neurodegenerative indications and the strength of our scientific approach.”
Buntanetap is an investigational oral therapy designed to reduce the production of toxic proteins in brain cells. Although the exact causes of Parkinson’s aren’t fully understood, toxic clumps of proteins such as alpha-synuclein are thought to play a central role in driving the disease, so reducing levels of these proteins is expected to help limit disease progression.
A previous Phase 3 trial (NCT05357989) tested buntanetap against a placebo in more than 500 people with early-stage Parkinson’s, most of whom did not have cognitive problems. Results showed that, in the subset of patients who’d been living with Parkinson’s for three years or more, buntanetap led to improvements on a measure of how much motor symptoms are interfering with day-to-day life.
Treatment shows promise in Alzheimer’s trial
Annovis is also developing buntanetap as a potential treatment for Alzheimer’s disease, which, like Parkinson’s, is a neurological disorder associated with toxic protein clumps in nerve cells. In an Alzheimer’s trial, the therapy was shown to improve a measure of cognition better than a placebo.
Both Alzheimer’s and Parkinson’s are associated with dementia, which refers to problems with memory and thinking that are severe enough to cause problems in day-to-day life. According to Annovis, nearly a third of people living with Parkinson’s have dementia, and most Parkinson’s patients will eventually develop the condition if they live long enough.
“Parkinson’s disease dementia represents a natural extension of both our Alzheimer’s and Parkinson’s programs,” said Cheng Fang, senior vice president of research and development at Annovis. “Across both indications, we have generated strong data demonstrating meaningful cognitive improvement with buntanetap. Despite being a serious problem, cognitive decline in Parkinson’s patients has received limited attention in the field. Our integrated data across multiple studies has opened a unique opportunity to address this unmet need and alleviate the cognitive burden in the Parkinson’s population.”
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