Date: Thursday, June 8, 2017
Session Time: 1:15pm-2:45pm
Location: Exhibit Hall C
To determine if baseline disease severity could be correlated to the effective dose of APL-130277 that was required to turn a patient with PD from OFF to fully ON.
Patients with PD frequently develop problematic OFF episodes despite optimization of therapies. APL-130277 (apomorphine) is administered sublingually and being studied for OFF episodes.
The open-label dose titration phase (DTP) was conducted to determine the appropriate dose of APL-130277 for each patient in the double-blind, placebo-controlled maintenance treatment phase (MTP). The titration sequence for APL-130277 was 10mg, 15mg, 20mg, 25mg, 30mg and 35 mg. Patients who responded with a full ON within 45 mins could move to the MTP. Patients who did not achieve a full ON returned to the clinic for the next dose. The process was repeated until patients achieved a full ON within 45 mins or reached 35mg. We evaluated if disease severity (assessed via the baseline levodopa dose, the mean number of OFF episodes per day, the Hoehn & Yahr [H & Y] scale score in the ON state, or the MDS-UPDRS Part III score in the OFF state) was correlated with the APL-130277 dose required to turn a patient with PD from OFF to fully ON.
Preliminary safety data is available for the 76 patients. Thirty-seven patients (49%) turned fully ON at the 10mg dose, 12 (16%) at 15mg, 10 (13%) at 20mg, 4 (5%) at 25mg, 11 (14%) at 30mg and 2 (3%) at 35mg. There was no correlation with baseline levodopa dose (R2=0.0759), the mean number of OFF episodes per day (R2=0.0095), H & Y in the ON state (R2=0.0023), or the MDS-UPDRS Part III score (R2=0.0007) and the dose that turned patients to a full ON.
In this analysis, the APL-130277 dose that turned patients from OFF to fully ON was not correlated with disease severity.
References: To be presented at the American Academy of Neurology, April 22-28, 2017 (Boston, MA)
To cite this abstract in AMA style:H. Fernandez, S. Isaacson, A. Espay, R. Pahwa, D. Truong, E. Pappert, P. Gardzinski, B. Dzyngel, A. Agro, R. Hauser. Disease severity is not predictive of the dose required for apomorphine sublingual film (APL-130277) to convert a patient with Parkinson’s disease(PD) from OFF to fully ON: Preliminary Results from a Phase III Study [abstract]. Mov Disord. 2017; 32 (suppl 2). http://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-diseasepd-from-off-to-fully-on-preliminary-results/. Accessed September 21, 2017.
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MDS Abstracts - http://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-diseasepd-from-off-to-fully-on-preliminary-results/