Evaluate and characterize the safety and tolerability profile of P2B001.

P2B001 is a once-daily, no titration, combination of low-dose, extended-release (ER) formulations of pramipexole and rasagiline (0.6/0.75mg), under investigation for patients with early Parkinson’s disease (PD). We have previously reported that P2B001 provides superior symptomatic efficacy to placebo and its components, and comparable efficacy with commercially available ER-Pramipexole (PramiER) titrated to optimal dose (mean 3.2mg).

Integrated safety analysis of phase 2 (NCT01968460) and phase 3 (NCT03329508) randomized, controlled, 12-week studies.

The integrated analysis included 199 patients with early PD (69% male; mean±SD age 63.8±9.2 years; time from diagnosis 5.9±7.9 months) who received P2B001. Overall, 118 (59%) patients reported ≥1 treatment-related AE (vs. 36% with placebo [n=50] and 70% with PramiER [n=74]); no serious-related AEs were reported with P2B001. Most (142/149, 95%) events reported with P2B001 were of mild-moderate intensity. Common AEs were nausea (19% vs. 2% with placebo and 23% withPramiER), somnolence (16% vs. 0 with placebo and 31% with PramiER), fatigue (14% vs. 2% with placebo and 18% with PramiER), dizziness (11% vs 8% with placebo and 10% with PramiER), and insomnia (8% vs. 4% with placebo and 10% with PramiER); other AEs were reported in ≤5% of patients. There was a lower frequency of dopaminergic TEAEs with P2B001 compared with PramiER (45.7% vs 66.2%, respectively); whereas these mostly emerged in the first 4 weeks of P2B001 treatment, the increased frequency persisted with PramiER. In the phase 3 study, there was no worsening from baseline in QUIP-RS-Total-Score in either the P2B001 or PramiER groups (change of -1.49 and -0.66, respectively).

P2B001 may offer patients with early PD a convenient, first-line, once-daily treatment with a favorable safety and tolerability profile compared to commercially available PramiER. P2B001-related AEs were mainly mild-moderate; no ICD-related concerns were observed.