Date: 2016-09-19
Type of information: Completion of the trial
phase: 1
Announcement: completion of the trial
Company: Prexton Therapeutics (Switzerland)
Product: foliglurax (PXT002331)
Action
mechanism: mGluR4 positive allosteric modulator. mGluR4 is a glutamate receptor, member of the G-Protein Coupled Receptor (GPCR) family and is believed to be a potential therapeutic target for Parkinson’s disease. Allosteric modulation of mGluR4 receptors is thought to exert regulatory activity onglutamate-mediated neurotransmission.
Disease: Parkinson's disease
Therapeutic area: Neurological diseases - CNS diseases
Country: UK
Trial
details: The principal aim of this study is to obtain safety and tolerability data when PXT002331 is administered orally as single and multiple doses to healthy subjects. (NCT02639221 )
Latest
news: * On September 19, 2016, Prexton Therapeutics announced the successful completion of the phase 1 clinical trial of PXT002331, their lead compound. A total of 64 healthy volunteers were enrolled to evaluate several doses of PXT002331, which has proved safe and well tolerated. A phase 2 trial for Parkinson’s disease patients is due in the first half of 2017 with the aim of demonstrating the effectiveness of the compound.
This study was the first in man clinical trial for an mGluR4 positive allosteric modulator. The randomized, double-blind, placebo controlled single and multiple ascending dose studies were designed to assess safety and tolerability of
PXT002331 dosed orally. It was completed on time and showed that PXT002331 is safe and well tolerated at doses well above those that produce robust effects in Parkinson’s disease animal models.
Prexton’s approach in the treatment of Parkinson’s stimulates a compensatory neuronal system that is not impacted by the disease. Competitors in this indication mostly target the dopaminergic system, which does not address all symptoms and is accompanied by a number of adverse effects. Prexton’s compound activates a specific target of the glutamatergic system, with the goal of providing a robust therapeutic effect without these adverse events.
* On March 7, 2016, Prexton Therapeutics announcesd the launch of a phase 1 clinical trial. The trial should be complete by mid 2016, with results expected in August 2016. Prexton’s compound activates a specific target of the glutamatergic system, with the goal of providing a robust therapeutic effect without the occurrence of
adverse events. The company aims to develop a group of first-in-class molecules that target the metabotropic Glutamate Receptor 4 (mGluR4), a protein belonging to the metabotropic glutamate receptor family. Preclinical data shows compelling evidence of efficacy for Prexton’s molecule. It has the potential to alleviate motor complications by modulating glutamate over activity in the central nervous system of Parkinson patients.
The phase 1 trial will include 72 subjects given ascending doses of the molecule, administered orally. The primary endpoint is to assess tolerability in healthy volunteers. The study will be financed by a $10 million (€8.86m) series A funding that closed in February 2015.
