Abstract Details

Title Safety and Efficacy of 24-Hour/Day Subcutaneous Infusion of Foslevodopa/Foscarbidopa in Advanced Parkinson’s Disease During a Phase 3 Study: 6-Month Interim Results

Topic Movement Disorders

Presentation(s) S16 - Movement Disorders: PD Biomarkers and Clinical Trials (5:06 PM-5:18 PM)

Poster/Presentation
Number 009

Background As PD progresses, oral levodopa loses effectiveness and motor complications develop, requiring alternative therapies. LDP/CDP is a new soluble formulation of levodopa/carbidopa prodrugs delivered as a CSCI via an ambulatory pump.

Objective Evaluate the safety, tolerability, and efficacy of foslevodopa/foscarbidopa (LDP/CDP, ABBV-951) delivered 24-hour/day as a continuous subcutaneous infusion (CSCI) for 52 weeks in advanced Parkinson’s disease (aPD) patients in an outpatient setting.

Design/Methods This Phase 3, open-label, single-arm study (NCT03781167) enrolled levodopa-responsive PD patients with a minimum of 2.5 hours of “Off” time/day. Assessments of systemic safety and local tolerability are the primary objective of this study. Secondary efficacy assessments include presence of morning akinesia, change from baseline in hours of “On” and “Off” time (PD diaries) and in ADL, sleep and quality of life (QoL) scores measured by MDS-UPDRS part II, PDSS-2, PDQ-39 and EQ-5D-5L.

Results As of 30March2021, 223 patients (60.1% male, 83.4% white, mean age of 64 years) were enrolled across 56 sites. Treatment emergent adverse events (AEs) were reported in 206 patients (92.4%). The most common AEs were erythema, nodule, cellulitis, and edema at the infusion site. The majority of AEs were mild or moderate and resolved spontaneously. Significant improvements in motor fluctuations were observed as early as Week 1; at Week 26 the mean increase in "On" time without troublesome dyskinesia was 3.24 hours and the decrease in "Off" time was 2.94 hours. Both "Off" and "On" time with dyskinesia decreased in favor of “On” time without dyskinesia. Improvements were also observed for morning akinesia, sleep, ADL and QoL.

Conclusions LCD/CDP was well-tolerated; systemic and skin AEs were consistent with those of levodopa and of other medications for subcutaneous delivery, respectively. The individualized, 24-hour/day, CSCI of LCD/LDP significantly reduced motor complications, improved morning akinesia, sleep disturbances and QoL, providing a minimally invasive therapeutic alternative for aPD patients.

Authors/Disclosures
Jason L. Aldred, MD, FAAN (Selkirk Neurology) PRESENTER	Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Medtronic. Dr. Aldred has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Boston Scientific. Dr. Aldred has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Abbvie. Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen . Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Allergan . Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Quadralynx. Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. Dr. Aldred has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Boston Scientific. Dr. Aldred has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Medtronic. Dr. Aldred has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Abbvie. Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Acorda. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Adamas. Dr. Aldred has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Allergan. Dr. Aldred has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Boston Scientific. Dr. Aldred has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for TEVA. Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Medtronic. Dr. Aldred has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for US World Meds. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Kyowa Kirin. Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sunovion. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Amneal. Dr. Aldred has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Biogen. Dr. Aldred has received personal compensation in the range of $100,000-$499,999 for serving as an Expert Witness for Arete Neuroscience, PLLC. The institution of Dr. Aldred has received research support from Biogen . The institution of Dr. Aldred has received research support from Abbvie. The institution of Dr. Aldred has received research support from Atara. The institution of Dr. Aldred has received research support from Takeda. The institution of Dr. Aldred has received research support from Merz. The institution of Dr. Aldred has received research support from AstraZeneca. The institution of Dr. Aldred has received research support from Neurocrine. The institution of Dr. Aldred has received research support from Aptinyx. The institution of Dr. Aldred has received research support from Cerevance. The institution of Dr. Aldred has received research support from Boston Scientific . The institution of Dr. Aldred has received research support from Parkinson Foundation . The institution of Dr. Aldred has received research support from Roche. The institution of Dr. Aldred has received research support from Theravance. The institution of Dr. Aldred has received research support from Triplet Therapeutics. The institution of Dr. Aldred has received research support from UCB. The institution of Dr. Aldred has received research support from Cerevel . The institution of Dr. Aldred has received research support from Sage Therapeutics. The institution of Dr. Aldred has received research support from Annovis. The institution of Dr. Aldred has received research support from Biovie. The institution of Dr. Aldred has received research support from Athira. The institution of Dr. Aldred has received research support from IRL. The institution of Dr. Aldred has received research support from NeuroDerm.
Bruno Bergmans (AZ St-Jan Brugge)	No disclosure on file
Camille Carroll, MD (University of Plymouth Faculty of Medicine and Dentistry)	The institution of Dr. Carroll has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. The institution of Dr. Carroll has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. The institution of Dr. Carroll has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bial. The institution of Dr. Carroll has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Global Kinetic. The institution of Dr. Carroll has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Scient. The institution of Dr. Carroll has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Kyowa Kirin. The institution of Dr. Carroll has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Medscape. The institution of Dr. Carroll has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Bial. The institution of Dr. Carroll has received research support from Parkinson's UK. The institution of Dr. Carroll has received research support from Edmond J Safra Foundation. The institution of Dr. Carroll has received research support from Cure Parkinson's. The institution of Dr. Carroll has received research support from Parkinson's UK. The institution of Dr. Carroll has received research support from NHSX.
	No disclosure on file
Jia Jia, PhD	Mr. Jia has received personal compensation for serving as an employee of Abbvie.
	No disclosure on file
Weining Robieson, PhD (AbbVie)	Dr. Robieson has received personal compensation for serving as an employee of AbbVie. Dr. Robieson has received stock or an ownership interest from AbbVie.
Amy M. Spiegel, PhD (AbbVie)	Amy Spiegel has received personal compensation for serving as an employee of AbbVie. Amy Spiegel has received stock or an ownership interest from AbbVie.
David G. Standaert, MD, PhD, FAAN (Univ of Alabama - Dept of Neurology)	Dr. Standaert has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbvie, Inc. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Curium Pharma. Dr. Standaert has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Gray Matter Technologies. Dr. Standaert has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi-Aventis. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Theravance, Inc. Dr. Standaert has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for International Parkinson and Movement Disorder Society. The institution of Dr. Standaert has received research support from Abbvie, Inc. The institution of Dr. Standaert has received research support from American Parkinson Disease Association. The institution of Dr. Standaert has received research support from Department of Defense. The institution of Dr. Standaert has received research support from National Institutes of Health. Dr. Standaert has received publishing royalties from a publication relating to health care. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving as a Speaker with Case Western Reserve. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving as a Consultant with California Pacific Medical Center. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving as a Course Instructor with International Parkinson Disease and Movement Disorders Society. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving as a Reviewer with National Institutes of Health. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving as a Consultant with Parkinson Study Group. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving as a Speaker with UCSD. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving as a Reviewer with Warren Alpert Foundation. Dr. Standaert has a non-compensated relationship as a Chair, Scientific Advisory Board with American Parkinson Disease Association that is relevant to AAN interests or activities.
Maurizio Facheris, MD, MSc (Abbvie Inc)	Dr. Facheris has received personal compensation for serving as an employee of AbbVie Inc.. Dr. Facheris has stock in AbbVie Inc..
Victor Fung, MD, MBBS, PhD	Dr. Fung has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. Dr. Fung has received publishing royalties from a publication relating to health care.