Foliglurax is an investigative treatment being developed by Prexton Therapeutics for the treatment of Parkinson’s disease, a progressive neurodegenerative disorder caused by the loss of dopaminergic neurons in the part of the brain responsible for movement and coordination.

How does foliglurax work?

Foliglurax works by activating a distinct system of nerve cells (neuronal system) possessing specific glutamate receptors, called metabotropic glutamate receptor 4 (mGluR4), which compensate for the deficiency of dopamine. Like dopamine, glutamate is a neurotransmitter that is released by nerve cells to send messages to other nerve cells.

The mGluR4 receptors are strategically localized to counteract neurotransmitter imbalance and restore motor behavior in patients. Preclinical data in animal models showed that activating mGluR4 is expected to restore the motor behaviors in Parkinson’s disease.

Several studies in animal models demonstrate that this strategy is promising for disease modification as well as for the treatment of motor and non-motor symptoms of Parkinson’s disease, such as resting tremor, muscle rigidity, and uncontrolled movements (called dyskinesia).

The drug is designed to provide long-term relief, unlike other Parkinson’s treatments that aim to replace dopamine or mimic its effects, which provide only initial symptomatic relief and lose effectiveness as the disease progresses.

Foliglurax in clinical trials

A single- and multiple-ascending oral dose Phase 1 trial (NCT02639221) in healthy volunteers with foliglurax was successfully completed in 2016. The results showed that foliglurax was safe and well-tolerated with an excellent pharmacokinetic (how the drug is processed in the body) profile.

Recently, the company announced the launch of a Phase 2 clinical trial (NCT03162874) with foliglurax. The trial will enroll 165 Parkinson’s patients in sites across six European countries (U.K., Germany, France, Austria, Spain, and Italy) starting in July 2017. The double-blind, randomized, placebo-controlled, parallel-arm study will assess the effectiveness, safety, and tolerability of foliglurax in reducing motor complications of levodopa therapy in patients experiencing end-of-dose wearing-off and levodopa-induced dyskinesia (LID).

Two groups will receive oral doses (10 mg and 30 mg) of the treatment over 28 days. A third group will receive a placebo. The primary outcome measure will be the change in the daily awake “off” time based on patient diary entries between the start and end of treatment. The study is expected to be completed in 2018.


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