Vimgreen Pharmaceuticals announced the completion of enrollment for its Phase 2 clinical trial evaluating VG081821AC for the treatment of early-to-mid stage Parkinson's disease (PD). The study, which enrolled 150 participants, is designed to assess the safety and efficacy of VG081821AC as a monotherapy.
The Phase 2 trial is a multicenter, randomized, placebo-controlled, double-blind study. Participants were randomized into three cohorts: a high-dose VG081821 group, a low-dose VG081821 group, and a placebo group, at a 1:1:1 ratio. The primary endpoint is the difference in change from baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III (motor symptoms) score between the VG081821 groups and the placebo group over the 12-week administration period.
Addressing Unmet Needs in Parkinson's Disease Treatment
Existing treatments for PD primarily focus on dopamine replacement strategies, including L-Dopa, dopamine agonists, MAO-B inhibitors, and COMT inhibitors. While L-Dopa is effective in reducing motor symptoms, long-term use often leads to motor complications such as wearing-off effects, ON-OFF fluctuations, and dyskinesia. Moreover, current therapies are symptomatic and do not slow disease progression. Approximately 1 million people in the United States are living with Parkinson's disease, and about 60,000 new cases are diagnosed each year, according to the Parkinson’s Foundation.
VG081821AC: A Novel Approach
VG081821AC is a selective adenosine A2A receptor (A2AR) antagonist and inverse agonist. As a non-dopaminergic therapy, VG081821AC has the potential to avoid, decrease, or delay motor complications associated with long-term L-Dopa use. Sanxing Sun, President and CEO of Vimgreen, stated that VG081821AC is intended to be used as a monotherapy to improve movement in early-to-mid stage PD, and later in combination with low doses of L-Dopa, potentially minimizing L-Dopa related issues and prolonging the quality of life for PD patients.
Potential for Precision Medicine
The trial will also analyze A2AR gene expression levels in peripheral blood mononuclear cells (PBMCs) to explore potential correlations between drug efficacy and A2AR expression. This may pave the way for VG081821AC to be used as a precision medicine in the future. The Phase 2 trial is expected to be completed in November.
VG081821AC targets adenosine A2A receptors, which are distributed in the basal ganglia, particularly the striatum, and are involved in motor function regulation. Vimgreen believes that VG081821AC's unique mechanism of action, as both a potent A2A antagonist and inverse agonist, could offer improved treatment options and clinical benefits for PD patients.
