The multicentre, 12-week, randomised, placebo-controlled, double-blind trial enrolled a total of 150 Parkinson’s patients. Credit: Momentum studio/Shutterstock.

Vimgreen Pharmaceuticals has concluded subject enrolment in its Phase II clinical trial of VG081821AC, a new therapy aimed at treating early-to-mid stage Parkinson’s disease (PD).

VG081821AC is an adenosine A2A receptor (A2AR) antagonist that also acts as an inverse A2AR agonist.

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The trial is designed to assess the safety and efficacy of VG081821AC as a monotherapy, with a focus on its potential to address motor symptoms associated with PD.

It is a multicentre, 12-week, randomised, placebo-controlled, double-blind trial and enrolled a total of 150 participants.

These subjects were randomised into one of three cohorts: a high-dose VG081821AC group, a low-dose group and a placebo group, each following a 1:1:1 ratio.

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Variations from baseline in motor symptoms, as measured by the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III score is the trial’s primary endpoint.

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Current PD therapies are said to rely on dopamine replacement strategies, with L-Dopa being the top choice.

Despite the effectiveness of these treatments in reducing motor symptoms, they often lead to motor complications over time and do not slow disease progression.

Vimgreen CEO and president Sanxing Sun said: “In most previous trials of A2A antagonists for the treatment of Parkinson’s Disease, A2A antagonists were used as an add-on treatment to alleviate off episodes in combination with L-Dopa for advanced PD patients. Although it has led to the approval of Istradefylline in US and Japan, it is not the best use of A2A antagonists for PD treatment.

“VG081821 is to be used as monotherapy for improving movements in early-to-mid stage of PD. Later on, as the disease progresses, it can be used in combination with low doses of L-Dopa. This L-dopa sparing effect may minimise the problem of L-Dopa and prolong the quality of life of PD patients.”