Topline results from a phase 3 trial of P2B001, a fixed-dose combination of extended release (ER) formulations of pramipexole and rasagiline, showed it was superior to its individual components as a first-line treatment for early Parkinson's disease.
Study participants also reported less daytime sleepiness with P2B001, according to a statement from the drug's manufacturer.
The trial data "support our view that P2B001 can provide clinical benefits comparable to higher doses of commercially available dopamine agonists, while mitigating the side effects typically associated with this class of medicine such as somnolence, orthostatic hypotension, and hallucinations," Sheila Oren, MD, chief executive officer of Pharma Two B, said in a statement.
"This is important for PD patients of all ages and is critical for the elderly, who typically do not tolerate side effects of dopamine agonists," Oren added.
The 12-week, international, randomized, double-blind trial was designed to study the efficacy, safety, and tolerability of P2B001 compared to its individual components and to a calibration arm of pramipexole ER in 544 patients with early PD.
Participants received P2B001, a once-daily ER combination product composed of pramipexole 0.6 mg and rasagiline 0.75 mg; pramipexole ER capsule 0.6 mg once daily; rasagiline ER capsule 0.75 mg once daily; or the currently marketed product pramipexole ER capsules titrated to an optimal dose for each individual patient (1.5 to 4.5 mg).
The adjusted mean change from baseline in total Unified Parkinson's Disease Rating Scale (UPDRS) score was -2.66 points for P2B001 vs pramipexole (P = .0018) and -3.30 points for P2B001 vs rasagiline (P = .0001). There was no significant difference in UPDRS scores between P2B001 and pramipexole ER.
The adjusted mean change from baseline in the Epworth Sleepiness Scale score for P2B001 vs pramipexole ER was -2.66 points (P < .0001).
Treatment-related adverse events were mostly mild or moderate and were similar among groups.
"The initiation of treatment of patients with Parkinson's disease represents an area of unmet need due to the side effects associated with current treatments," Warren Olanow, MD, professor emeritus of neurology and neuroscience at the Icahn School of Medicine at Mount Sinai in New York City, said in a statement from the manufacturer.
"Based on the data from this well-designed, rigorous, active-controlled study, P2B001 has the potential to become a leading treatment option for PD, particularly as first line therapy for early-stage patients of all ages," Olanow added.
The company plans to file a new drug application in 2022.
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Cite this: Positive Phase 3 Topline Results for Early Parkinson's Drug - Medscape - Dec 27, 2021.