Prexton Therapeutics (Prexton), a biopharmaceutical company developing novel therapeutic compounds for the treatment of Central Nervous System (CNS) conditions, today announces the launch of phase II clinical testing of its investigational drug candidate, Foliglurax, in Parkinson’s disease (PD). The clinical study will evaluate 165 patients in sites across six European countries (UK, Germany, France, Austria, Spain and Italy), starting in July 2017.
The study is double-blind, randomised, placebo-controlled parallel-arm phase II in subjects who are experiencing the two major issues associated with PD, namely the wearing-off of Levodopa and Levodopa-Induced Dyskinesia (LID). The trial will assess the safety and tolerability of Foliglurax and the change from baseline to end of treatment period in the daily awake off-time.
Current PD treatments primarily aim to replace dopamine or to mimic its effects. This approach only provides initial symptomatic relief, but loses efficacy as the disease progresses. Foliglurax works by stimulating a novel compensatory neuronal system that activates a specific glutamatergic system target (mGluR4) that is unaffected by PD. The aim is to treat the motor symptoms of PD, such as resting tremor, muscle rigidity ('off-time') and uncontrolled movements ('Dyskinesia').
A phase I trial with Foliglurax was successfully completed in September 2016. The results showed that Foliglurax was safe and well-tolerated with an excellent pharmacokinetic profile.
“The start of this phase II trial is another significant milestone for Prexton and for Parkinson’s patients desperately in need of novel and innovative therapeutic solutions,” said Francois Conquet, CEO of Prexton Therapeutics. “We are excited about the potential of Foliglurax in addressing these needs.”
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