Long-term resultsat 60 weeks

VYALEV met its primary endpoint at 12 weeks

Results: From baseline to week 12 in the phase 3 clinical trial, patients in the VYALEV group (n=73) experienced an increase in good "On" time without troublesome dyskinesia of 2.72 hours (baseline 9.20 hours) vs 0.97 hours (baseline 9.49 hours) with the oral IR CD/LD group (n=67) (mean difference=1.75 hours; P=0.0083). Good "On" time includes periods without dyskinesia or with non-troublesome dyskinesia, averaged over a 16-hour awake period based on the PD diary.1

Study Design: VYALEV was studied in a phase 3, randomized, double-blind, double-dummy, active-controlled, 12-week, multicenter study in 141 patients* with advanced PD whose motor fluctuations were inadequately controlled by their current medication. One VYALEV patient was not evaluable for the efficacy analysis.1 See full study design.

*Of the 141 patients who were randomly assigned in the trial, 110 completed the study. Of the 74 patients randomized to receive VYALEV, 48 completed the study and 26 discontinued treatment. One patient did not have PD diary data. Of the 67 patients randomized to receive oral IR CD/LD, 62 completed the study and 5 discontinued treatment.2

OLE study Good “On” time over 60 weeks of treatment with VYALEV1,3

Mean normalized daily “On” time without troublesome dyskinesia†

Normalized Time, Hours, Mean
Week
+3.47Hours frombaseline +4.69Hours frombaseline

Study Design: This analysis presents interim results from the ongoing 96-week OLE study for patients who received VYALEV in the randomized, double-blind parent study and continued receiving VYALEV in the OLE study. The primary endpoint of the OLE study was safety. Data for 60 total weeks of VYALEV use, including 12 weeks from the RCT and an additional 48 weeks from the OLE study, are shown (interim data cutoff: September 14, 2022). The primary endpoint of the RCT was assessed at week 12.

OLE Limitations: There is potential for enrichment of OLE data; unblinding patients may cause bias related to overall treatment effect; data is descriptive in nature and findings should be interpreted with caution.

AO Disclosure: In an as observed (AO) analysis, missing visit data was excluded from calculations for that visit, which may increase the percent of responders. All observed data was used regardless of premature discontinuation of study drug, or initiation of concomitant medication. The same patient may not have a response at each timepoint.

†Assessments are based on PD diaries of the full analysis set and are defined as all patients who received VYALEV infusions in the OLE study with efficacy measures recorded at OLE study baseline and ≥1 post-baseline visit.

‡Baseline value was collected at parent study baseline.

§Week 12 was the end of the double-blind RCT and the baseline of the OLE study.

Review the safety data from the open-label extension trial.

Review safety

AE=adverse event; BL=baseline; OLE=open-label extension; PD=Parkinson’s disease.