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.

About IRL790

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.

For further information

Nicholas Waters, CEO                
Phone: +46 730 75 77 01                
E-mail: nicholas.waters@irlab.se

Joakim Tedroff, CMO 
Phone: +46 70 760 16 91
E-mail: joakim.tedroff@irlab.se

This information is information that IRLAB Therapeutics AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08:45 CET on November 15, 2017.

FNCA Sweden AB is the company's Certified Adviser on Nasdaq First North Premier.

About IRLAB

IRLAB is a research and development company, listed on Nasdaq First North Premier, focused on development of novel therapies for the treatment of neurodegenerative diseases, in particular Parkinson’s disease and dementia.

IRLAB has two clinical candidate drugs, IRL752 and IRL790, focused on medical needs in Parkinson’s disease. IRLAB also has additional programs in pre-clinical stages.

IRLAB’s research is aimed at discovery and development of new candidate drugs addressing unmet medical need in diseases of the central nervous system, using the unique and proprietary integrative screening process, ISP.

IRLAB is based in Gothenburg, Sweden. The operations are mainly carried out through the subsidiary Integrative Research Laboratories Sweden AB.

For more information, please visit www.irlab.se.

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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.
Joakim Tedroff, 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.
Nicholas Waters, CEO