IRLAB’s Phase IIb/III study in Parkinson’s disease to target Good ON
IRLAB’s clinical Phase IIb/III study with the drug candidate mesdopetam (IRL790) in development for the treatment of levodopa induced dyskinesia (LIDs) in Parkinson’s disease, will have a study design with the following main points: · Approximately 140 patients evenly distributed across four groups: three dose levels of mesdopetam and one placebo group and a three-month study duration. · The planned 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 planned to be conducted at centers in Europe and USA. In-depth explorative analysis of data from the Phase IIa study with mesdopetam in Parkinson’s patients with LIDs (Levodopa Induced Dyskinesia) indicates that the daily time without troublesome dyskinesias, called “Good ON”, increases dose dependently. In the study, the best performing dose was 7.5 mg twice daily with Good ON increasing by 5.6 hours daily, compared with 1 hour (p<0.002) in the placebo group. This represents a significant improvement of Good ON for these patients who, prior to treatment, had approximately 6.3 hours Good ON per day. Higher dosing did not show additional benefit to the patient.
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· Approximately 140 patients evenly distributed across four groups: three dose levels of mesdopetam and one placebo group and a three-month study duration.
· The planned 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 planned to be conducted at centers in Europe and USA.
In-depth explorative analysis of data from the Phase IIa study with mesdopetam in Parkinson’s patients with LIDs (Levodopa Induced Dyskinesia) indicates that the daily time without troublesome dyskinesias, called “Good ON”, increases dose dependently. In the study, the best performing dose was 7.5 mg twice daily with Good ON increasing by 5.6 hours daily, compared with 1 hour (p<0.002) in the placebo group. This represents a significant improvement of Good ON for these patients who, prior to treatment, had approximately 6.3 hours Good ON per day. Higher dosing did not show additional benefit to the patient.
"When mesdopetam was given in addition to standard Parkinson medication, patients experienced considerably longer periods of good daily motor function without aggravated involuntary movements. This is highly relevant since involuntary, levodopa-induced dyskinesia is a major problem in the treatment of Parkinson's disease preventing optimal treatment.", says Joakim Tedroff, CMO at IRLAB. "Mesdopetam represents a new approach that, by inhibiting the mechanisms in the brain that has the most impact on levodopa dependent development of troublesome dyskinesias, and thus, can prevent these, improving the daily function in these severely affected patients."
"The treatment effects seen in our Phase IIa study exceeds the results published for other treatment strategies in troublesome dyskinesias. We believe that mesdopetam has a very good chance to offer a completely new and better treatment strategy for the large group of Parkinson’s patients with levodopa induced dyskinesia”, said Nicholas Waters, CEO at IRLAB.
The strategy for the Phase IIb/III study has been developed in collaboration with international regulatory and clinical experts. The strategy is based on the results from IRLAB’s Phase I, Phase Ib and Phase II studies with mesdopetam as well as the common use of patient diaries in previous marketing authorizations granted by regulatory authorities for pharmaceutical drugs in the treatment of Parkinson’s disease.
“The strategy planning for the Phase IIb/III-study with mesdopetam in Parkinson’s disease is now completed. We have recently also secured financing for the study and initiated a collaboration with a highly reputable CRO", said Nicholas Waters.
The study preparations are progressing according to plan. As a part of the work with the Phase IIb/III study with mesdopetam, preparations are now underway for the applications to regulatory agencies and ethics committees in selected countries for permission to start the study in the second half of 2020.
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