MapLight Therapeutics has concluded the Phase I clinical trial of ML-007 for treating neurologic ailments such as schizophrenia and dyskinesia.
The single ascending dose, double-blind, randomised, placebo-controlled trial analysed the safety, tolerability, and pharmacokinetic and pharmacodynamic profile of ML-007.
It enrolled 58 healthy adult subjects aged 18 to 45 years across seven cohorts.
In the trial, six cohorts were given escalating oral doses of the compound while participants in the seventh cohort received ML-007 plus a peripherally restricted muscarinic antagonist.
According to the findings, the compound was well-tolerated without any serious adverse events.
ML-007 showed on-target activity by eliciting the predicted peripheral effects of muscarinic activation, with these effects being dose-limited as anticipated.
Assessment of escalating oral doses of ML-007 aided in detecting a maximum tolerated dose of the monotherapy.
When given along with the peripherally restricted anticholinergic, the compound could hinder objective peripheral muscarinic symptom measures.
ML-007’s pharmacokinetics were favourable with dose-proportional exposure, quick absorption, and reduced inter-subject variability.
Target CSF concentrations were attained at well-tolerated doses of the compound.
A second clinical compound developed leveraging the MapLight platform, ML-007, is an M1/M4 muscariniec agonist.
It acts on circuits deemed to be interrupted in neurologic ailments.
MapLight Therapeutics CEO and founder Christopher Kroeger said: “The successful completion of our ML-007 Phase I clinical trial is a major milestone for MapLight.
“This study is a significant step forward for our M1/M4 muscarinic agonist programme, a programme that we believe will yield a best in class therapy for patients suffering with schizophrenia and dyskinesia.”