Objective: Evaluate whether baseline disease severity is predictive of the effective APL-130277 dose to turn a patient with Parkinson’s disease (PD) from OFF to fully ON.

Background: APL-130277 is a sublingual film being studied in Phase 3 trials to rapidly turn patients ON from OFF episodes by delivering apomorphine via the oral mucosa.

Methods: PD patients with at least one OFF episode/day and = or > 2 hours of daily OFF time were included. Patients were dosed in the OFF state, starting with APL-130277 10 mg and, if needed, increased in 5 mg increments until fully ON was achieved, to a maximum of 30 mg. We evaluated if disease severity (as assessed via the Hoehn & Yahr (H&Y) or the OFF MDS-UPDRS-Part III score) was correlated with the effective APL-130277 dose (i.e., the dose the patient turns fully ON).

Results: Of the 19 patients dosed, 15 converted from OFF to fully ON with APL-130277. Twenty percent of patients at the 10 mg dose, 33% at the 15 mg dose, 27% at the 20 mg dose, 13% at the 25 mg dose and 7% at the 30 mg dose achieved a full ON. There was no correlation with either the baseline H&Y score (R2=6E-05) or the OFF MDS-UPDRS-Part III score (R2=0.0004) and the dose that turned patients to a full ON. Additionally, there were no correlations with any of the individual items from the MDS-UPDRS- Part III and the effective dose of APL-130277.

Conclusions: Disease severity did not predict the effective dose needed to turn an OFF patient to a full ON state. This data would support titrating patients from the lowest available dose. Phase 3 studies are ongoing to further evaluate efficacy and safety of APL-130277.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/disease-severity-is-not-predictive-of-the-dose-required-for-apomorphine-sublingual-film-apl-130277-to-convert-a-patient-with-parkinsons-disease-from-off-to-fully-on/