Clinical Studies with P2B001
Phase II Clinical Trial
Phase IIb clinical trial with P2B001 has been completed.
The study titled A Phase 2B, Twelve-week Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study, To Determine the Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson's Disease has enrolled a total of 149 newly diagnosed patients in 29 clinical sites in the USA and Israel. The results of the study demonstrated that both doses tested provided highly significant and clinically meaningful benefits in comparison to placebo, with a good safety profile. The study included a large variety of efficacy and safety endpoints, many of which are specifically used for evaluation of new Parkinson’s disease medications and known to be useful quantitative measures of effective treatment and potential adverse effects. The overall evaluations of efficacy and safety were robust and point to a clinically meaningful improvement similar or even better than existing treatments currently used in higher doses.
The results of the Phase IIb clinical study were recently published in the prestigious Journal Movement Disorders.
P2B001 Clinical Study Results
Figure 1. Results of the United Parkinson's Disease Rating Scale (UPDRS) score, the world-wide accepted scale for evaluating Parkinson's disease drugs. Both doses of P2B001 show a strong, clinically meaningful effect, with robust statistical difference from placebo.
Phase I / PK Clinical Trial
After completion of the pre-clinical evaluation of P2B001, indicating the synergy between the combination components and the significant contribution of the sustained-release formulation which further enhances the efficacy, Pharma Two B developed an oral dosage form for the product, consisting of sustained release profiles for both components.
The company tested P2B001 in a Phase I / PK clinical trial. The trial was a 4-arm, cross-over study in which the components in their currently available commercial forms, alone or together, were compared to P2B001. The study was very successful with results indicating a very good safety and PK profiles.