Benzinga | Oct 28, 2021 08:16AM EDT

AbbVie Reports ABBV-951 Showed Improvements In Controlling Motor Fluctuations vs Oral Levodopa/Carbidopa Medication In Phase 3 Trial For Parkinson's

-- The pivotal Phase 3, randomized, double-blind, double-dummy, active-controlled study of continuous, subcutaneous infusion of ABBV-951 (foslevodopa/foscarbidopa) in patients with advanced Parkinson's disease met its primary endpoint in a 12-week study

-- Patients who received 24 hours/daily ABBV-951 showed statistically significant increases in hours of "On" time without troublesome dyskinesia, compared to oral levodopa/carbidopa. A significant reduction in hours of "Off" time was also observed

-- Systemic adverse events were generally consistent with the well-established safety profile of levodopa/carbidopa medications and infusion site adverse events were mostly non-serious and mild or moderate in severity

-- Data from this head-to-head superiority study will be a key component of global regulatory submissions

NORTH CHICAGO, Ill., Oct. 28, 2021 /PRNewswire/ -- AbbVie (NYSE:ABBV) today announced that continuous 24 hours/day subcutaneous infusion of ABBV-951 (foslevodopa/foscarbidopa) was statistically superior to oral levodopa/carbidopa in reducing motor fluctuations in patients with advanced Parkinson's disease (PD) in a Phase 3, randomized, double-blind, double-dummy, active-controlled study. The study met its primary endpoint of increase from baseline in "On" time (hours) without troublesome dyskinesia (involuntary movements) after 12 weeks based on the Parkinson's Disease Diary (PD Diary).1 These results will be a key component of global regulatory submissions.

The increase in "On" time at week 12 was 2.72 hours for ABBV-951 versus 0.97 hours for oral levodopa/carbidopa (LD/CD) (p= 0.0083).1 Improvements in "On" time were observed as early as the first week and persisted throughout the 12 weeks.1 It was also observed that an improvement from baseline in hours of average daily normalized "Off" time followed a similar pattern in reductions versus oral LD/CD after the first week and persisting through week 12.1 Decreases in "Off" time after 12 weeks were 2.75 hours for ABBV-951 versus 0.96 hours for oral LD/CD (p=0.0054).1

"Parkinson's disease is a progressive, irreversible neurological disease with debilitating symptoms that can make daily life challenging," said Michael Severino, M.D., vice chairman and president, AbbVie. "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."

"Patients need more therapeutic options to control their symptoms and troublesome dyskinesia for this debilitating disease," said Jason Aldred, M.D. FAAN of Selkirk Neurology, clinical associate professor at the University of Washington, clinical assistant professor at Washington State University Elson S. Floyd College of Medicine, and a principal investigator of the study. "These data are promising and demonstrate positive results on a key endpoint used to assess efficacy of treatments for patients with advanced Parkinson's."

The majority of the adverse events (AEs) reported were non-serious and mild to moderate in severity in the ABBV-951 group.1 Incidence of serious AEs were 8% and 6% in the ABBV-951 group and oral LD/CD group, respectively.1 There was one patient with a treatment-emergent AE leading to death in the oral LD/CD group and none in the ABBV-951 group.1 The most common AEs reported in ?5% in the ABBV-951 group were infusion site AEs (erythema, pain, cellulitis, edema, bruising, hemorrhage, nodule, induration, infection, and pruritus), dyskinesia, "On" and "Off" phenomenon, fall, hallucinations (including visual hallucination), balance disorder, constipation and peripheral swelling.1 The incidence of infusion site AEs was higher in the ABBV-951 group than in the oral LD/CD group and most of them were non-serious, mild to moderate in severity, resolved with or without treatment and none led to systemic complications.1 Incidence of hallucination and psychosis AEs was higher in the ABBV-951 group than in the oral LD/CD group.1 These AEs were non-serious, mild to moderate in severity. Incidence of falls and associated injuries was lower in the ABBV-951 group compared to the oral LD/CD group.1 Adverse events led to study treatment discontinuation in 21.6% of patients in the ABBV-951 group and 1.5% in the oral LD/CD group.1

Full results from the Phase 3 study will be presented at a future medical meeting or submitted for publication in a peer-reviewed journal. ABBV-951 is an investigational therapy and it is not approved for use. The safety and efficacy of ABBV-951 have not been evaluated by regulatory authorities.