The studies showed that ADX48621, a metabotropic glutamate receptor 5 negative allosteric modulator in development for Parkinson’s disease levodopa induced dyskinesia (PD-LID), is safe and well-tolerated in healthy volunteers, including those over 50 years old, the company said.
Study ADX48621-102 consisted of two parts. Part one was a randomized, two-way crossover comparison in 12 healthy subjects of the pharmacokinetics, safety and tolerability of the original active pharmaceutical ingredient in capsule with the modified release capsule.
Part two was a double-blind, placebo-controlled, multiple ascending, repeat dose study in 24 healthy subjects using three different doses of the modified release formulation. The study showed that the new formulation achieved satisfactory pharmacokinetics, safety and tolerability with single and repeat dose administration across the dose range planned to be used for the Phase IIa proof of concept study in PD-LID, which is expected to start later in 2009.
Study ADX48621-103 was a two-period crossover study that evaluated the safety, tolerability and pharmacokinetics of ADX48621 following single oral dosing in older healthy subjects (aged over 50 years) both fasting and following a high fat meal. ADX48621 was well tolerated by this group of older subjects and gave satisfactory drug exposure both in the fasted and fed states, the company said.
Charlotte Keywood, chief medical officer of Addex, said: The good safety and tolerability results for ADX48621 in older subjects are of particular interest because we plan to start Phase IIa proof of concept studies with the compound in Parkinson’s disease dyskinesia later in 2009.