IRLAB signs agreement with TCTC to conduct Phase-2 study with IRL790
Development of IRLAB Therapeutics’ candidate drugs continues according to plan and an agreement has been signed with The Clinical Trial Company Ltd (TCTC) to conduct the planned Phase 2 study with the drug candidate IRL790. The study will be conducted at clinics in the UK. Thereby, IRLAB enters into Phase 2 studies with both their candidate drugs – IRL790 and IRL752 – during the autumn.
The Phase 1b study regarding IRL790, which was concluded during spring 2017, provided positive and very valuable information about safety, tolerability, dosing and efficacy, supporting the planning of the upcoming Phase 2 study. This study aims to confirm efficacy indicated in the phase Ib study and further examine safety and tolerability of IRL790 in the treatment of Parkinson’s disease patients suffering from L-dopa Induced Dyskinesias (PD-LIDs), an indication with limited treatment options and big medical need.
An agreement has been signed with TCTC, a Clinical Research Organisation (CRO), to conduct the study. Together with TCTC, IRLAB now has the organisation in place to conduct the Phase 2 study in the UK.
“The results from Phase 1 and Phase 1b studies in patients with Parkinson’s disease and levodopa-induced dyskinesia in Sweden is promising for the continued development of IRL790. We have recently completed a feasibility analysis in the UK and found that UK clinics have a high clinical competence regarding Parkinson’s disease, a large patient base, and interest in conducting the Phase 2 study. We are looking forward to working with our colleagues at TCTC who have an extensive experience from conducting international clinical trials in neurodegenerative diseases”, says Joakim Tedroff, IRLAB’s chief medical officer (CMO).
“TCTC is delighted to work with IRLAB on this study. There is a huge unmet medical need to improve the lives of patients with Parkinson’s disease and IRL790 is an exciting new potential treatment for patients with Parkinson’s disease dyskinesia. We are very much looking forward to working with the IRLAB team and the UK investigators to deliver this important study”, says Susan McGoldrick TCTC’s CNS Project Director.
IRL790 is developed for the treatment of PD-LIDs, involuntary movements that often follows treatment with levodopa, and PD-P, psychosis in Parkinson’s disease. In pre-clinical studies, IRL790 reduces involuntary movements that occurs after a period of treatment with L-dopa. Additionally, in pre-clinical studies, IRL790 has shown antipsychotic properties. The company believes that IRL790 thus has the potential to simultaneously treat both dyskinesias and psychosis in Parkinson’s disease.