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.