IRLAB Provides Update on Mesdopetam's Phase IIb Study Data and the Plans Toward Phase III - Seite 2

In the FAS, mesdopetam's treatment effect on Hauser diary "good ON" (ON-time without troublesome dyskinesia) did not reach statistical significance, whereas in the PS, among subjects taking the 7.5 mg b.i.d. dose of mesdopetam, a significant and clinically meaningful increase in "good ON"-time of 1.75 hours vs placebo ("good ON" scaled to 16 hours awake time, p=0.050) was observed.

In the FAS, mesdopetam demonstrated significant anti-dyskinetic effects, as measured by UDysRS, sum of parts 1, 3 and 4, with a reduction of 6.2 points vs. placebo (p=0.026) at 7.5 mg b.i.d. In the PS, the effect on UDysRS was dose-dependent and a reduction of 9.2 points vs. placebo (p=0.011) was observed at 7.5 mg b.i.d. In the UDysRS disability score parts 1b+4, assessing the degree of disability caused by dyskinesia, there was a reduction of 3.5 points vs. placebo (p=0.062) in the FAS and, in the PS a reduction of 5.5 points vs placebo (p=0.019) was observed at 7.5 mg b.i.d.

This means that both patients and physicians report reduced disability related to dyskinesia during mesdopetam treatment. Further, the daily time spent in OFF showed a clear dose-dependent pattern and a decrease compared to placebo in both FAS and PS, reaching 1.27 hours (p=0.051) at the 7.5 mg b.i.d. dose in the PS, indicating a direct anti-parkinsonian effect of mesdopetam in subjects treated with levodopa. Mesdopetam was well tolerated with an adverse event and safety profile on par with placebo.

"I think the mesdopetam data package is one of the most compelling available in the symptomatic treatment of Parkinson's. Mesdopetam has the rare ability to both improve dyskinesias and improve parkinsonism and, at the same time, appears to be well tolerated. I expect it will have both clinical utility and commercial success," said Karl Kieburtz, MD, MPH, Professor in Neurology, Former chairman of the Peripheral and Central Nervous System US FDA Advisory Committee; chairman of the Scientific Evaluation Committee for the Cooperative Studies Program, Veterans Administration, and the National Institute of Neurologic Disorders and Stroke.

The Phase I clinical studies performed by Ipsen to prepare for Phase III were successfully completed and showed favorable results. One study evaluated pharmacokinetics (PK) in different populations showing that mesdopetam has similar PK in Asian and Non-Asian populations. A second study evaluated the potential for PK drug-drug interactions, via key drug metabolizing enzymes, showing a low risk of drug-drug interaction, suggesting that neither additional clinical drug-drug interaction studies nor restrictions on future patient enrolment would be required in future clinical studies. A third study investigated elimination routes of mesdopetam showing no risk of accumulation of mesdopetam in the body. Safety data from all three studies did not reveal any new safety signals and thus, was consistent with the current knowledge of the safety profile for mesdopetam.