P2B001 for PD

P2B001

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.

Drug-Drug Combinations Treatment for Parkinson’s Disease

The combination offered by P2B001 is unique. It is low dose combination of two active ingredients currently used in PD that act in complementary mechanisms.

What are the components of the combination?

P2B001 is comprised of the active ingredients rasagiline, which is an inhibitor of the enzyme that regulates the levels of dopamine, and pramipexole, which has structural similarity to dopamine.

Together, these two drugs support each other’s activity, by increasing the amount of available dopamine, and at the same time, activating the dopamine receptor. The activities of these two drugs in combination and in sustained release formulation has been proven effective in previous trials in Parkinson’s disease patients.

P2B001 has a unique formulation and release profile, in which the two drugs are released from the capsule in an adapted manner, throughout the day, with the aim of maximizing mutual activity. P2B001 is designed to provide a combination of low doses of these two drugs with the aim of providing more effective control of Parkinson’s disease symptoms than each of the drugs taken alone or, the current available commercial drugs taken together. Pharma Two B is currently evaluating this hypothesis in a Phase III clinical trial.

P2B001 is an investigational product and is not currently approved by any regulatory authority.