P2B001 is a low dose, sustained release combination of pramipexole and rasagiline. P2B001 is dosed once daily with no titration. Data from P2B001 phase II clinical trial implies that it may provide significant therapeutic effects comparable to those published for higher doses of the individual components, with favorable safety profile.
Monoamine oxidase-B inhibitors or dopamine agonists are approved treatments for early PD patients are associated with efficacy or safety limitations. P2B001, contains low doses of the dopamine agonists pramipexole, and the monoamine oxidase-B inhibitor rasagiline that have complementary mechanisms of action. Preclinical studies demonstrate that the combination provides synergistic effects, which are further enhanced if both agents are given in slow release. The synergy between the combination components implies that lower doses maybe used without compromising the therapeutic effect, while maintaining manageable safety profile, due to the decreased drug amounts.
In a double blind, placebo controlled multi center phase IIb clinical trial in 149 early PD patients in the US and Israel, P2B001 robustly met all endpoints, including the United Parkinson’s Disease Rating Scale (UPDRS), which is the hallmark of early PD evaluation, various Quality of Life scales, and in the Clinical Global Impression of Disease Severity Scale (where P2B001 also showed a significant change). As published, Twice-daily, low-dose pramipexole in early Parkinson’s disease: a randomized, placebo-controlled trial. Kieburtz K1Parkinson Study Group PramiBID Investigators Mov Disord 2011 Jan;26(1):37-44, the benefits observed with the slow release combination product candidate, P2B001, were achieved with doses lower than are currently used for pramipexole and rasagiline monotherapy and were associated with a very favorable adverse event profile.
P2B001 is currently in phase III clinical study in the US, Canada and Europe.