AbbVie has reported that its Phase III clinical trial of subcutaneous dose of ABBV-951 (foslevodopa/foscarbidopa) met the primary goal in advanced Parkinson’s disease (PD) patients.
A solution of levodopa and carbidopa (LD/CD) prodrugs, ABBV-951 is intended for continuous subcutaneous dosage.
The randomised, double-dummy, double-blind, active-controlled Phase III trial analysed the efficacy, safety and tolerability of ABBV-951 versus oral LD/CD in subjects with advanced PD.
The primary goal of ‘good’ time contrary to ‘bad’ time is collected and averaged over three successive days and regularised to a typical waking period of 16 hours.
‘Good’ time is described as ‘on’ time without dyskinesia or involuntary movements plus ‘on’ time with non-troublesome dyskinesia while ‘bad’ time is defined as off time plus ‘on’ time with troublesome dyskinesia.
The trial enrolled nearly 130 adult subjects with advanced PD across 80 centres worldwide.
Findings showed that the continuous subcutaneous infusion of ABBV-951 administered 24 hours a day demonstrated to be statistically superior to oral LD/PD in lowering motor fluctuations in PD patients.
A rise from baseline in ‘on’ time without troublesome dyskinesia after 12 weeks was observed as the primary goal.
For ABBV-951, the rise in ‘on’ time at week 12 was 2.72 hours as against 0.97 hours for oral LD/CD. Furthermore, improvements in ‘on’ time were noted during the first week and lasted throughout the treatment duration of 12 weeks.
Most of the adverse events (AEs) observed in the trial were non-serious and mild to moderate in severity in the ABBV-951 arm.
Systemic AEs were in line with the already established safety profile of LD/CD treatment.
AbbVie vice-chairman and president Michael Severino said: “Parkinson’s disease is a progressive, irreversible neurological disease with debilitating symptoms that can make daily life challenging.
“We’re committed to addressing the continued needs of patients and are encouraged by these results that highlight a potential alternative treatment option for those affected by advanced Parkinson’s disease.”
The company intends to submit the trial data as a crucial component for regulatory filings across the globe.
Earlier this month, AbbVie reported results from new Phase III data analyses of KEEPsAKE-1 and KEEPsAKE-2 trials where treatment with risankizumab (Skyrizi) improved signs and symptoms of psoriatic arthritis in adult patients.