IRLAB starts Phase IIb/III study with mesdopetam in the US
IRLAB (Nasdaq Stockholm: IRLAB A) announced today that recruitment in the phase IIb/III study with mesdopetam (IRL790) has started in the US. Mesdopetam is in development for the treatment of levodopa-induced dyskinesias in Parkinson’s disease, PD-LIDs, with the objective to increase daily “good ON-time”.
“Patient recruitment started four weeks after FDA acceptance of the IND for mesdopetam, which is a testament of the team’s diligent work. Mesdopetam can make a big difference for Parkinson’s disease patients. We now take additional important steps towards our goal to offer efficient treatment,“ says Nicholas Waters, CEO at IRLAB.
The clinical phase IIb/III study with mesdopetam is a randomized, double-blind and placebo-controlled study with the aim of evaluating the effect of mesdopetam in patients with Parkinson’s disease affected by troublesome dyskinesias.
The primary outcome measure is change in daily hours of ON-time without troublesome dyskinesia as assessed with 24-hour patient home diaries. The study is designed to randomize approximately 140 patients distributed across four groups, three dose levels of mesdopetam and a placebo group with approximately 35 patients in each group. Each patient will have a three-month treatment period.
Parallel application processes for the Phase IIb/III study to regulatory authorities and ethics committees are ongoing in selected European countries.
For more 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
About mesdopetam
Mesdopetam (IRL790) is a dopamine D3 receptor antagonist in development for the treatment of PD-LIDs, troublesome dyskinesias commonly occurring after treatment with levodopa, and psychosis in Parkinson’s disease. In preclinical and initial clinical studies, mesdopetam reduces troublesome dyskinesia by increasing “Good ON” that occurs after treatment with levodopa. Analysis of the data from the recently completed Phase IIa study showed a dose dependent improvement of this measure. Patients treated with mesdopetam 7,5 mg twice daily had, on average, 5.6 hours longer Good ON compared with 1 hour in the placebo group (p<0,002). Additionally, in preclinical studies, mesdopetam has also shown antipsychotic properties. IRLAB believes that mesdopetam thus has the potential to simultaneously treat both troublesome dyskinesias and psychosis in Parkinson’s disease.
About IRLAB
IRLAB is a Swedish research and development company that focuses on developing novel treatments in Parkinson’s disease. The company's most advanced candidates, mesdopetam (IRL790) and pirepemat (IRL752), both of which completed Phase IIa-studies, intends to treat some of the most difficult symptoms related to Parkinson's disease: involuntary movements (PD-LIDs), psychosis (PD-P) and symptoms linked to cognitive decline such as impaired balance and increased risk of falls (PD-Falls). Through the proprietary research platform, ISP (The Integrative Screening Process), IRLAB discovers and develops unique drug candidates for central nervous system (CNS) related disorders where large and growing medical need exist. In addition to the clinical candidates, the ISP platform has also generated several CNS programs that are now in preclinical phase. IRLAB is listed on Nasdaq Stockholm Main Market. More information on www.irlab.se.