Swiss biopharmaceutical firm Prexton Therapeutics has begun a Phase II clinical trial (AMBLED) of Foliglurax for the treatment of patients suffering with Parkinson’s disease (PD).
Foliglurax is an investigational therapeutic candidate designed to trigger a new compensatory neuronal system, which induces a glutamatergic system target called mGluR4.
The drug candidate is expected to treat PD’s motor symptoms, including resting tremor, muscle rigidity (off-time) and uncontrolled movements known as dyskinesia.
Set to be conducted in the UK, Germany, France, Austria, Spain and Italy, the double-blind, randomised, placebo-controlled parallel-arm Phase II trial will enrol a total of 165 subjects currently experiencing wearing-off of levodopa and levodopa-induced dyskinesia (LID).
The efficacy, safety and tolerability of 10mg and 30mg of Foliglurax, alongside the ability of the investigational candidate to minimise motor complications by levodopa therapy will be evaluated over the 28-day trial duration.
Prexton Therapeutics CEO Francois Conquet said: “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.
“We are excited about the potential of Foliglurax in addressing these needs.”
The AMBLED trial’s primary outcome is the measure of change from baseline to end of treatment period in the daily awake off-time and the results from the trial are expected to be available in 2019.
According to data from a Phase I trial conducted in September last year, Foliglurax was safe, well-tolerated and also demonstrated favourable pharmacokinetic profile.