New trial offers extended buntanetap access for people with Parkinson’s
Study will evaluate the investigational therapy’s long-term safety and effects
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- A new long-term study will evaluate the safety and effects of buntanetap in people with Parkinson’s disease.
- Buntanetap is an oral therapy designed to reduce the production of proteins linked to neurodegeneration, including alpha-synuclein.
- The study will follow patients for up to three years, tracking motor and cognitive function as well as biomarker changes.
A new study will investigate the long-term safety and effects of the experimental treatment buntanetap in people with Parkinson’s disease, according to Annovis Bio, the therapy’s developer.
The open-label extension (OLE) study (NCT07284784) is expected to enroll about 500 adults with Parkinson’s disease, ages 40 to 85, according to the trial listing. Participants will receive a once-daily 30 mg oral dose of buntanetap for up to 36 months, or about three years. Enrollment is expected to begin this month at multiple sites across the U.S.
The OLE will include people who previously took part in clinical trials of buntanetap, allowing them to remain on treatment for a longer period, as well as patients who have been receiving deep brain stimulation (DBS) for at least 12 months — a treatment that uses mild electrical pulses to modulate abnormal brain activity and help ease Parkinson’s symptoms.
Company opens long-term extension for eligible participants
“Launching the OLE study is a natural next step for our Parkinson’s program,” Maria Maccecchini, PhD, President and CEO at Annovis, said in a company press release. “In our previous [Parkinson’s disease] trial, many patients shared they experienced noticeable improvements and were eager to stay on treatment. Being able to offer them continued access to buntanetap truly matters to us.”
Beyond extending access to therapy, the study is designed to help researchers better understand buntanetap’s long-term safety and potential effects, including changes in disease-related biomarkers.
“At the same time, this study will allow us to take a longer-term view of buntanetap,” Maccecchini said. “By following patients over an extended period, we will further measure buntanetap’s safety and evaluate its sustained benefits on both motor and cognitive functions. Collecting biomarker data will also help us deepen our understanding of buntanetap’s potential as a disease-modifying treatment.”
A hallmark of Parkinson’s is the buildup of misfolded proteins in the brain, particularly alpha-synuclein. These protein aggregates are thought to damage and destroy nerve cells, resulting in both motor symptoms and non-motor symptoms.
Buntanetap is an investigational oral therapy designed to reduce the production of toxic proteins in brain cells. These include alpha-synuclein, as well as beta-amyloid and tau — proteins whose abnormal buildup is a hallmark of Alzheimer’s disease and has also been linked to cognitive decline in some people with Parkinson’s.
Earlier clinical trials showed safety and potential benefits
In a previous Phase 1/2 trial (NCT04524351), daily treatment with buntanetap for 25 days was generally well tolerated and was associated with improvements in cognitive and motor function in people with Parkinson’s disease. The therapy was also reported to reduce overall disease severity, with the greatest effects observed at daily doses of 10 mg and 20 mg. Treatment was also linked to significant reductions in blood levels of TDP-43, a protein associated with neurodegeneration when abnormally aggregated.
Encouraged by these findings, a subsequent Phase 3 trial (NCT05357989) was launched to evaluate buntanetap over a six-month period in individuals with early Parkinson’s. In the completed study, the 20 mg dose was reported to significantly improve motor function in patients who had been diagnosed for more than three years, as well as in those with postural instability and gait difficulties. The same dose also significantly outperformed placebo on measures of cognitive decline, particularly among participants with mild dementia.
More recent analysis showed that, in a subgroup of Phase 3 participants with evidence of amyloid buildup and faster cognitive decline, treatment was also associated with reductions in several established biomarkers of neurodegeneration commonly used in Alzheimer’s research.
New study will follow patients up to 3 years to assess sustained effects
Now, the OLE study will evaluate how patients respond to buntanetap over longer periods of time, including changes after treatment discontinuation and during a treatment-free interval. Researchers will also assess patient responses when buntanetap is restarted, which may provide insight into the therapy’s potential long-term effects.
The OLE will also enroll people with Parkinson’s who have been receiving DBS for at least one year. Because DBS patients are often excluded from clinical research, including them will allow Annovis to evaluate buntanetap’s safety and effects in this real-world population.
“We remain deeply committed to addressing areas of significant unmet medical need,” said Melissa Gaines, senior vice president of clinical operations at Annovis. “Patients receiving DBS have long been underserved in clinical research, and this study represents an important opportunity to better understand how a new therapeutic option may support them.”
Annovis noted that long-term OLE data may also help inform its future regulatory plans for buntanetap. The company recently announced plans to meet with the U.S. Food and Drug Administration this month to discuss buntanetap as a potential treatment for dementia due to Parkinson’s disease.
