IRLAB receives approval to initiate Phase II trials with IRL752

IRLAB has received approval from Läkemedelsverket (the Swedish MPA) and Regionala Etikprövningsnämnden, EPN, (the Ethics committee, Stockholm) to conduct a Phase II clinical trial with IRL752. IRL752 is a cortical enhancer designed to treat Parkinsons disease dementia.

“The approval from the MPA and the ethics committee is very encouraging. The Phase II study with IRL752 is a double-blind placebo controlled study in patients with Parkinson’s disease and dementia. About 80 % of all patients suffering from Parkinson’s disease  develops symptoms of dementia which, today, lack satisfactory treatment.”. says Joakim Tedroff, IRLAB’s chief medical officer (CMO)

The Phase II study is designed to study effects of IRL752 on cognitive and motor symptoms in patients with Parkinson’s disease and dementia. The study will also include collection of data from families and caregivers to provide information on how the treatment affects daily living. The primary objective is to study safety and tolerability of IRL752 in this patient population.

In the previously conducted Phase I study, IRL752 was found to be well tolerated with a very god safety profile. No effects on vital signs or laboratory analyses collected in the study was observed. IRL752 displays dose linear pharmacokinetics. Food intake does not affect uptake or distribution of the compound.

IRLAB develops IRL752 for the treatment of dementia in Parkinson's disease. Pre-clinical animal studies have previously shown that IRL752 increases the levels of the neurotransmitters dopamine, norepinephrine and acetylcholine in the synapses of the frontal cortex. IRL752 has also shown effects on memory enhancement as well as antidepressant and antipsychotic effects. In conducted Phase I-studies, IRL752 displayed a very good safety and tolerability profile in healthy subjects, which is consistent with the results from pre-clinical studies.

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 13:45 CET on August 25, 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 currently runs programs with two candidate drugs, IRL752 and IRL790, both prepared for Phase II clinical studies, and three programs in pre-clinical phase. 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 is mainly carried out through the subsidiary Integrative Research Laboratories Sweden AB.

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

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The approval from the MPA and the ethics committee is very encouraging. The Phase II study with IRL752 is a double-blind placebo controlled study in patients with Parkinson’s disease and dementia. About 80 % of all patients suffering from Parkinson’s disease develops symptoms of dementia which, today, lack satisfactory treatment.
Joakim Tedroff, CMO