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Abstract Details

Exploratory Delayed-Start Analysis Of PASADENA Part 3 52-Week OLE Evaluating Prasinezumab Efficacy On Motor Progression And Complications In Early-Stage PD
Movement Disorders
S32 - Movement Disorders: Trials (4:18 PM-4:30 PM)
005

Prasinezumab is a humanised monoclonal antibody designed to target aggregated alpha-synuclein and slow disease progression in Parkinson’s disease (PD). PASADENA (NCT03100149) is multicentre, randomised, double-blind, placebo-controlled study evaluating the efficacy of prasinezumab in participants with early-stage PD.

Here, we describe the results of PASADENA Part 2 at Week 104 and Part 3 Week 52 open-label extension (OLE).

Participants with early-stage PD (diagnosis ≤2 years of age at screening; Hoehn & Yahr Stages I–II) were randomised to receive intravenous prasinezumab every 4 weeks (1500 mg or 4500 mg) for approximately three years (early-start group), or placebo for 52 weeks followed by prasinezumab (1500 mg or 4500 mg) for approximately two years (delayed-start group). All 316 PASADENA participants were considered in the analysis, with participants included regardless of change in symptomatic therapy. Motor progression and motor complications were defined, respectively, as a ≥5-point increase on the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III and reaching a score ≥1 point on MDS-UPDRS Part IV, and were analysed using Cox proportional hazards models.

Baseline characteristics were balanced between individuals in the early- and delayed-start groups. At the end of Part 2, fewer participants in the early-start group showed motor progression (80.1%) or developed motor complications (45.0%) compared with the delayed-start group (89.5% and 55.2%) (hazard ratio: 0.77 [80% confidence interval (CI) 0.65–0.91] and 0.74 [80% CI 0.60–0.92]). One-year results from Part 3 will be further described.

The PASADENA Part 3 OLE is currently ongoing, and we aim to describe the long-term safety and efficacy on a yearly basis.

Authors/Disclosures
Paulo Pacheco Fontoura, MD, PhD, FAAN (Roche Pharmaceuticals)
PRESENTER
Dr. Fontoura has received personal compensation for serving as an employee of F. Hoffmann La Roche. Dr. Fontoura has stock in Roche Pharmaceuticals.
Gennaro Pagano, MD, PhD, eMBA (F. Hoffmann-La Roche Ltd) Prof. Pagano has received personal compensation for serving as an employee of F.Hoffmann-La Roche Ltd. Prof. Pagano has stock in F.Hoffmann La Roche Ltd.
Stefano Zanigni Dr. Zanigni has received personal compensation for serving as an employee of Eli-Lilly and Company. Dr. Zanigni has received personal compensation for serving as an employee of F. Hoffmann-La Roche Ltd. Dr. Zanigni has stock in F. Hoffmann-La Roche Ltd.
Annabelle Monnet (F. Hoffmann-La Roche Ltd) Mrs. Monnet has received personal compensation for serving as an employee of F. Hoffmann-La Roche Ltd.
Kirsten I. Taylor Kirsten I. Taylor has received personal compensation for serving as an employee of F. Hoffmann-La Roche Ltd. Kirsten I. Taylor has received stock or an ownership interest from F Hoffman-La Roche Ltd.
Andrea Hahn Ms. Hahn has received personal compensation for serving as an employee of Excelya Germany GmbH, Freiburg, Germany.
Tanya Simuni, MD, FAAN (Northwestern University Feinberg School of Medicien) Dr. Simuni has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for cadia, AcureX, Adamas, AskBio, Amneal, Blue Rock Therapeutics, Caraway Therapeutics, Critical Path for Parkinson's Consortium (CPP), Denali, Michael J Fox Foundation, Neuroderm, Sanofi, Sinopia, Roche, Takeda and Vanqua Bio. Dr. Simuni has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for of Koneksa, Neuroderm, Sanofi, UCB, AcureX, Adamas, AskBio, Biohaven, Denali, GAIN, Neuron23 and Roche. Dr. Simuni has received research support from Amneal, Biogen, Neuroderm, Prevail, Roche, and UCB and an investigator for NINDS, MJFF, Parkinson's Foundation.
Kenneth L. Marek, MD (IND) Dr. Marek has received personal compensation for serving as an employee of IND. Dr. Marek has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for invicro. Dr. Marek has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche. Dr. Marek has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi. Dr. Marek has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biohaven. Dr. Marek has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for takeda. Dr. Marek has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Denali. Dr. Marek has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Koneksa. Dr. Marek has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Xingimaging. Dr. Marek has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neuron23. Dr. Marek has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lilly. Dr. Marek has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biohaven. Dr. Marek has received research support from Michael J Fox Foundation.
Ronald Postuma, MD (Montreal General Hospital) Dr. Postuma has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche, Biogen, Takeda, Theranexus, GE, Jazz, Curasen, Paladin, Inception Sciences, Phytopharmics, Vaxxinity, Merck. Dr. Postuma has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen/Partners. The institution of Dr. Postuma has received research support from CIHR, Weston Foundation, Webster Foundation, Roche, MJFF, Parkinson Canada, FRSQ, NIH.
Nicola Pavese, MD (Newcastle University) Dr. Pavese has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. The institution of Dr. Pavese has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bial. Dr. Pavese 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. Pavese has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Britannia. The institution of Dr. Pavese has received research support from Multiple System Atrophy Trust. The institution of Dr. Pavese has received research support from Parkinson's UK. The institution of Dr. Pavese has received research support from Independent Research Fund Denmark. The institution of Dr. Pavese has received research support from European Union. The institution of Dr. Pavese has received research support from MRC.
Fabrizio Stocchi Fabrizio Stocchi has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Bial, Biogen, Sunovion, Lundbeck, UCB, Zambon, Chiesi, Lusofarmaco, Abbvie, Neuroderm, Kyowa, Synegile, Roche, Britannia, Sunovion, Blue Rock. Fabrizio Stocchi has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for BIAL, Zambon, Biogen, Roche, Synegile, Sunovion. Fabrizio Stocchi has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Bial, Zambon, UCB, Kyowa, Sunovion.
Hanno Svoboda, PhD (Roche) Dr. Svoboda has received personal compensation for serving as an employee of Roche Diagnostics GmbH. Dr. Svoboda has stock in Hoffmann La Roche.
Rachelle S. Doody, MD, PhD Dr. Doody has received personal compensation for serving as an employee of F. Hoffman-LaRoche. Dr. Doody has stock in F. Hoffman-LaRoche.
Geoffrey A. Kerchner, MD, PhD (Genentech, Inc.) Dr. Kerchner has received personal compensation for serving as an employee of F. Hoffmann-La Roche, Ltd.. Dr. Kerchner has stock in F. Hoffmann-La Roche, Ltd.. Dr. Kerchner has received publishing royalties from a publication relating to health care.
Azad Bonni, MD, PhD (F. Hoffmann-La Roche Ltd, Roche Innovation Center Basel) Dr. Bonni has received personal compensation for serving as an employee of F.Hoffmann-La Roche Ltd. Dr. Bonni has stock in F.Hoffmann-La Roche Ltd.
Tania Nikolcheva Tania Nikolcheva has received personal compensation for serving as an employee of F. Hoffmann La Roche. Tania Nikolcheva has stock in F. Hoffmann La Roche.