Neurocrine Biosciences presents new data analyses demonstrating efficacy of once-daily Ongentys in patients with Parkinson's disease at the MDS Virtual Congress 2020.

Neurocrine Biosciences, Inc. announced new data from two post-hoc analyses of Phase III data, demonstrating that once-daily Ongentys (opicapone) capsules decreased "off" time and increased "on" time without troublesome dyskinesia as an add-on therapy to levodopa/carbidopa in patients with Parkinson's disease who experience motor fluctuations. Neurocrine Biosciences also presented real-world data showing the increased burden motor fluctuations have over time on Parkinson's disease patients and the healthcare system through significantly more hospitalizations and emergency room visits. These data are among several studies and analyses of Ongentys being presented in collaboration with BIAL at the MDS Virtual Congress 2020 on September 12–16. Ongentys, approved by the FDA in April 2020, is the first and only once-daily catechol-O-methyltransferase (COMT) inhibitor approved as an add-on to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes and will be available to wholesalers in September. Data from a pooled post-hoc, sub-group analysis of Phase III studies demonstrated that Ongentys 50 mg significantly reduced "off" time by more than an hour compared to placebo when used as an add-on treatment in patients with Parkinson's disease treated with levodopa/carbidopa plus placebo at baseline (109.2 minutes for Ongentys 50 mg [n=67] vs. 40.3 minutes for placebo [n=59]; p=0.0161). In a separate post-hoc analysis, Ongentys significantly increased absolute "on" time by approximately one additional hour compared with entacapone (124 minutes [n=50] vs. 60 minutes [n=47]; p=0.0344) when used as the first COMT inhibitor add-on therapy to levodopa/carbidopa in patients with Parkinson's disease recently diagnosed with motor fluctuations. Neurocrine Biosciences also presented real-world data from a retrospective medical chart review of adult patients with Parkinson's disease who began experiencing motor fluctuations while taking levodopa . Of the 310 patients included in the review, 117 (38%) had a history of motor fluctuations of greater than 2 years. Data show that emergency department visits were significantly more frequent in patients with Parkinson's disease with a longer history of motor fluctuations ( greater than 2 years) compared to patients with a shorter history (13% [n=15] vs. 3% [n=5]; P<0.001). similarly, hospitalizations were significantly more frequent in patients with a longer history of motor fluctuations (15% [n="18]" vs 6% [n="12]," p><0.01). among patients who were hospitalized, the mean length of stay was shorter in patients with motor fluctuations greater than 2 years versus patients with motor fluctuations less than 2 years, but the difference was not statistically significant (0.5 vs 1.1 days; p>0.05). About the BIPARK-1 Study :BIPARK-1 was a Phase III, randomized, double-blind placebo- and active-controlled study of Ongentys as an adjunct to levodopa therapy in which approximately 600 patients with Parkinson's disease and motor fluctuations received once-daily doses of opicapone (5 mg, 25 mg, or 50 mg), placebo, or 200 mg doses of the COMT inhibitor entacapone for 14 to 15 weeks. The primary endpoint was the change from baseline in absolute time in the "off" state, as assessed by patient diaries. The initial study period was followed by a one-year open-label phase during which all patients received treatment with opicapone. About the BIPARK-2 Study :BIPARK-2 was a Phase III, randomized, double-blind placebo-controlled study of opicapone as an adjunct to levodopa therapy in which approximately 400 patients with Parkinson's disease and motor fluctuations received once-daily doses of opicapone (25 mg or 50 mg) or placebo for 14 to 15 weeks. The primary endpoint was the change from baseline in absolute time in the "off" state, as assessed by patient diaries. The initial study period was followed by a one-year open-label phase during which all patients received treatment with opicapone. BIPARK-1 and BIPARK-2 were conducted by BIAL – Portela & CA, S.A. (BIAL). Neurocrine Biosciences in-licensed opicapone from BIAL in 2017 and has exclusive development and commercialization rights in the U.S. and Canada. BIAL received approval from the European Commission for Ongentys as an adjunct therapy to preparations of levodopa/DOPA decarboxylase inhibitors in adult patients with Parkinson's disease and end-of-dose motor fluctuations who cannot be stabilized on those combinations. BIAL currently markets Ongentys in Germany, United Kingdom, Spain, Portugal and Italy.