IRL790 for treatment of dyskinesias and psychosis in Parkinson´s disease

Purpose and goal

IRL790 has been studied in a full GLP safety pharmacology and toxicology program in accordance with regulatory requirements, including up to 28-days repeated dose studies in rats and dogs. These studies are required by authorities for their evaluation of approval to start of clinical Phase I trials in man. In addition, analytical methods, to support in vitro and in vivo studies, have been developed and validated according to guidelines.

Results and expected effects

High exposure in rat and dog plasma is achieved after oral administration of IRL790. Dose regimens have been developed to obtain high and maximal exposure during 28 day treatment in both species. IRL790 was tolerated well with expected pharmacodynamic effects in the 28 days treatments in rat and dog. IRL790 has no effects in the required GLP assays of mutagenicity and lacks appreciable interactions with the hERG ion channel.

Approach and implementation

Accelera in Italy was contracted to perform the full GLP safety pharmacology and toxicology package in accordance with regulatory requirements. TKT Sweden AB, was contracted for scientific advice and project management. The project has progressed well with some delays in the dog studies. The reason for this delay is an unforeseen shortage in availability of dogs for GLP studies in Europe. The total cost for the project increased relative to budget. The increased costs are related to additional analyses which were not possible to foresee and to fluctuations in exchange rates