Abstract Details

Title A Novel Levodopa/Carbidopa Prodrug (ABBV-951) 24-Hour Continuous Subcutaneous Infusion Treatment for Parkinson’s Disease

Topic Movement Disorders

Presentation(s) P3 - Poster Session 3 (5:30 PM-6:30 PM)

Poster/Presentation
Number 10-037

Objective Characterize the levodopa pharmacokinetics (PK) and safety/tolerability of ABBV-951 in a first-in-human study following continuous subcutaneous (SC) infusion.

Background Parkinson’s disease is the second most common neurodegenerative disease and is characterized by progressive degeneration of the dopaminergic system resulting in bradykinesia, rigidity, tremor and postural instability. Early stage symptoms are managed with oral treatment; however, as Parkinson’s disease progresses, symptoms are no longer well controlled by oral medication due to the short half-life of levodopa and a narrowing therapeutic window. Duopa (levodopa-carbidopa intestinal gel) can overcome the short half-life of levodopa and offer superior efficacy compared to oral levodopa/carbidopa; however, this delivery requires percutaneous endoscopic gastrostomy (PEG) tube placement . ABBV-951 is a novel levodopa/carbidopa prodrug which has the potential to be delivered through a minimally invasive SC infusion and provide therapeutic levels of levodopa.

Design/Methods ABBV-951 was administered SC to the abdomen to 6 healthy older (45-75 years old) volunteers over a 72 hour period. Serial plasma PK samples were collected to assay for levodopa concentrations. Safety and tolerability were assessed throughout the study.

Results Following ABBV-951 administration, levodopa mean PK profile over initial 16 hours is similar to previous Duopa phase 1 study in Parkinson’s disease patients. ABBV-951 still maintains stable levodopa exposures for the rest treatment period. Steady state levodopa exposure was achieved at 2 hours indicating rapid conversion of the prodrug to levodopa. Four/six subjects reported mild infusion site pain ≤30 minutes after infusion initiation with no reports of pain after. Following the initiation of infusion one subject had an adverse event of edema at the infusion site.

Conclusions ABBV-951 was able to provide stable levodopa exposures over 72 hours via a less invasive SC route of delivery.

Authors/Disclosures
Matthew Rosebraugh, PhD (AbbVie) PRESENTER	Dr. Rosebraugh has received personal compensation for serving as an employee of AbbVie Inc. Dr. Rosebraugh has stock in AbbVie Inc..
	No disclosure on file
Wei Liu	Wei Liu has received personal compensation for serving as an employee of AbbVie. Wei Liu has received stock or an ownership interest from AbbVie.
Maurizio Facheris, MD, MSc (Abbvie Inc)	Dr. Facheris has received personal compensation for serving as an employee of Vanqua Bio. Dr. Facheris has stock in Vanqua Bio.
Janet Benesh, BSMT (Abbott Laboratories)	No disclosure on file

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