IRLAB receives MHRA approval to conduct Phase II trials with IRL790 in Britain
IRLAB has received approval from the Medicines & Healthcare products Regulatory Agency (MHRA) to conduct a Phase II study with the drug candidate IRL790 for treatment of L-dopa induced dyskinesias (LIDs). The study will be conducted at UK clinics.
This Phase II clinical trial aims to study effect of IRL790 on dyskinesia in patients suffering from LIDs using UDysRS (the Unified Dyskinesia Rating Scale), the scale accepted by regulatory bodies. The 74 patients study will be conducted at several UK centres and is expected to be concluded in Q3 2018.
The Phase II study is based on, and aims to confirm, the previous and successful Phase Ib study concluded during spring 2017 in patients with advanced Parkinson’s disease.
“We are pleased that the planned UK Phase II study has rapidly received MHRA approval. There is a high interest among UK clinicians to participate in the study. We are looking forward to work with our UK colleagues and benefit from their extensive experience of clinical trials”, says Dr Joakim Tedroff, IRLAB’s chief medical officer (CMO).
“The approval from MHRA validates IRLABs technology by another independent competent authority. This supports the IRLAB capability to produce robust, international clinical drug candidates and projects” says Dr Nicholas Waters, IRLABs CEO.
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.