Phase I program with IRL790 for treatment of dyskinesias and psychosis in Parkinson´s disease
| Reference number | |
| Coordinator | Integrative Research Laboratories Sweden AB |
| Funding from Vinnova | SEK 4 983 902 |
| Project duration | December 2015 - June 2016 |
| Status | Completed |
Purpose and goal
The objectives of this project were to conduct Phase 1 studies (SAD and MAD) on IRL790 in healthy volunteers, to assess safety, tolerability and pharmacokinetics, and to secure finances to enable further clinical development and organic growth of IRLAB. Having successfully met these objectives, an application for a Phase Ib study in Parkinson´s disease patients, based on the data generated in the project, has been submitted to the Swedish MPA.
Expected results and effects
Based on the studies performed, IRL790 displays a favourable pharmacokinetic, safety and tolerability profile, both upon single ascending dose administration and upon repeated dosing, providing a basis for further clinical development. IRL790 is well tolerated and displays linear kinetics over a dose range covering and exceeding relevant clinical dosages. In parallel with the clinical studies, efforts are ongoing to finance the continued development of IRL790 towards marketing, resulting in secured financing of the next step in the clinical development programme.
Planned approach and implementation
The studies were performed in accordance with the pre-specified time-plan and budget, in collaboration with Clinical Trial Consultants (CTC), Uppsala, Recipharm OT Chemistry, Uppsala, MetaSafe AB, Södertälje, and Juniper Pharma and PCI, UK.