Enrollment complete in trial of experimental Parkinson’s treatment
VT-5006 targets gut-related mechanisms believed to contribute to disease
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- Vertero Therapeutics completed patient enrollment in a Phase 1b clinical trial testing VT-5006 in Parkinson’s disease.
- The experimental treatment targets gut-related bacterial mechanisms believed to contribute to the disease.
- The trial will assess safety and pharmacokinetics in 24 adults, with top-line data expected by the end of the year.
Vertero Therapeutics has completed patient enrollment in a Phase 1b clinical trial testing VT-5006, an experimental treatment designed to target gut-related mechanisms believed to contribute to Parkinson’s disease.
The Phase 1b study (NCT07310264) includes 24 adults with early- or moderate-stage Parkinson’s. It will assess the treatment’s safety and how it moves into, through, and out of the body, as well as whether it engages its intended biological target. The company expects to report top-line data by the end of the year, which will inform dose selection and study design for a Phase 2 trial.
“Completing enrollment in our Phase 1b study is an exciting milestone reflecting the defined and urgent unmet need in this community for novel therapeutics that can go beyond symptom management to targeting underlying drivers of disease,” Becca Senter, PhD, Vertero’s chief scientific officer, said in a company press release. “We look forward to evaluating these topline data as we define the path forward for the VT-5006 clinical development program.”
Preclinical studies found that VT-5006 reduced brain inflammation
Parkinson’s is caused by the loss of nerve cells that produce dopamine, a chemical messenger involved in controlling movement, leading to motor symptoms such as tremors, muscle stiffness, and slow movement. Nonmotor symptoms affecting cognition, sleep, and mental health are also a part of the disease.
Current treatments are focused on increasing the levels of dopamine in the brains of patients, or on managing symptoms.
VT-5006 is a small, gut-selective molecule designed to disrupt compounds made of CsgA, a protein produced by certain gut bacteria that can form amyloid structures to anchor them to the gastrointestinal wall. Research suggests CsgA may promote alpha-synuclein aggregation and inflammation, mechanisms thought to contribute to nerve cell death in Parkinson’s.
By targeting CsgA in the gut, the treatment ultimately aims to slow disease progression and ease Parkinson’s symptoms. The approach is consistent with the body-first hypothesis, which proposes that Parkinson’s-related biological changes may begin in the gut and travel to the brainstem via the vagus nerve.
The clean safety profile and activity that we observed across all dose levels in our Phase 1a study were encouraging and directly informed our approach in this patient cohort.
According to Vertero, preclinical studies found that VT-5006 reduced inflammation and other disease-related changes in the brain, improved motor function, and slowed disease progression, with a favorable safety profile.
The Phase 1a part of the study enrolled healthy volunteers, who received VT-5006 or a placebo either as a single dose or once daily for seven days. Completed earlier this year, the study found that VT-5006 was generally safe and well tolerated, and showed a favorable pharmacological profile.
“The clean safety profile and activity that we observed across all dose levels in our Phase 1a study were encouraging and directly informed our approach in this patient cohort,” Senter said.
The Phase 1b part of the trial includes people with Parkinson’s who tested positive for CsgA and were diagnosed within the past 10 years. Participants are randomly assigned to receive a low or high dose of VT-5006, or a placebo, once daily for 28 days. Dosing began earlier this year.
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