A phase 3 study evaluating a novel fixed-dose combination of extended release (ER) formulations of pramipexole and rasagiline (P2B001) in adults with early Parkinson disease met its primary and key secondary endpoints.
The 12-week, multinational, randomized, double-blind, double-dummy, active-controlled study (ClinicalTrials.gov Identifier: NCT03329508) included 544 patients with early Parkinson disease. Patients were randomly assigned to 1 of 4 treatment arms: P2B001 (pramipexole 0.6mg and rasagiline 0.75mg) once daily; pramipexole ER capsule 0.6mg once daily; rasagiline ER capsule 0.75mg once daily; or currently marketed pramipexole ER capsule titrated to an optimal dose (1.5 to 4.5mg) for each patient.
The fixed-dose combination therapy was found to be superior to each component based on the adjusted mean change from baseline to week 12 in the total Unified Parkinson Disease Rating Scale (UPDRS) score (primary endpoint; -2.66 points for P2B001 vs pramipexole 0.6mg [P =.0018] and -3.30 points for P2B001 vs rasagiline 0.75mg [P =.0001]).
P2B001 was also associated with significantly less somnolence compared with the marketed pramipexole ER, as measured by the adjusted mean change from baseline to week 12 in the Epworth Sleepiness Scale score (secondary endpoint; -2.66 points; P <.0001). Similar changes in total UPDRS score from baseline to week 12 were also observed for P2B001 and the marketed pramipexole ER (-7.98 points and -8.35 points, respectively).
“The data from this phase 3 study 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,” said Dr Sheila Oren, MD, MBA, Chief Executive Officer of Pharma Two B.
The Company plans to submit a New Drug Application for P2B001 to the Food and Drug Administration (FDA) in 2022.
Pharma Two B announces positive topline results from its pivotal phase iii study of P2B001 in early Parkinson’s disease. News release. Pharma Two B Ltd. Accessed December 15, 2021. https://www.globenewswire.com/news-release/2021/12/15/2352532/0/en/Pharma-Two-B-Announces-Positive-Topline-Results-from-its-Pivotal-Phase-III-Study-of-P2B001-in-Early-Parkinson-s-Disease.html.