IRLAB announces positive results from Phase Ib study with IRL790
IRLAB Therapeutics AB, listed on Nasdaq First North Premier, announces positive results from a controlled safety and tolerability Phase Ib study in patients with advanced Parkinson’s disease. IRL790 displayed a good safety profile in the dose range studied. Reported adverse events were generally mild and transient, and no serious adverse events were reported.
Fifteen patients with advanced Parkinson’s disease, displaying complications of therapy, were randomized to either placebo or IRL790 treatment during four weeks. Mean age of patients were 70 years (51-82). Placebo or IRL790 were administered as add-on to the patient’s treatment with l-dopa and other anti-parkinsonian medications. Safety, tolerability and pharmacokinetics were assessed throughout the study. During the first two weeks of the study doses were titrated individually and thereafter kept stable for the additional two weeks.
In this randomized placebo-controlled trial of IRL790, dyskinesia was assessed by means of the Unified Dyskinesia Rating Scale (UDysRS) at baseline and at 28 days. Unified Parkinson’s disease Rating Scale (UPDRS) and a Parkinson’s KinetiGraph™ system (PKG) were used to assess effects on PD.
The scales used indicated a decrease of involuntary movements, dyskinesias, in patients treated with IRL790 in the doses studied. A corresponding decrease was not observed in the placebo group. IRLAB Therapeutics is now preparing for a Phase II-study. The planned phase II study is fully financed.
The full press release, in Swedish, can be found by clicking this link: