Date: 2014-03-18
Type of information:
phase: 2b
Announcement: initiation of the trial
Company: Pharma Two B (Israel)
Product: P2B001 (combination of rasagiline and pramipexole)
Action
mechanism: Pharma Two B’s P2B001 synergistically combines two drugs already individually approved for the treatment of the early stages of Parkinson’s disease, rasagiline and pramipexole. These drugs have limited efficacy as monotherapies in low doses or require dose increases with time, which consequently lead to specific side effects. Pharma Two B has shown during the pre-clinical development stage of P2B001, that low doses of the combination components, which have very little, if any, therapeutic benefit when given individually produce a very high effect when given in combination. These benefits are due to the synergistic effects of the two components, which are further enhanced by the sustained release profile of the product, designed to provide a high therapeutic outcome with a better safety profile.
Disease: Parkinson’s disease
Therapeutic area: Neurodegenerative diseases
Country: Israel, USA
Trial
details: 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 will enroll a total of 150 patients, at twenty five leading clinical sites in the U.S and five sites in Israel. C. Warren Olanow, M.D., professor of neurology and neuroscience at Mount Sinai Hospital in NY, and Karl Kieburtz, M.D., professor of neurology, public health science and environmental medicine at the University of Rochester Medical Center, are the clinical leaders of the study.This study will evaluate an oral fixed-dose, once daily product that combines pramipexole and rasagiline for the treatment of early Parkinson\'s disease. Animal studies support the therapeutic advantage of combining low doses of rasagiline and pramipexole and suggest further improvement when both are administered in a sustained fashion. Both rasagiline and pramipexole are well known marketed drugs for Parkinson\'s disease with a good safety profile. combining the drugs in low doses and controlled release may provide better symptom management than the existing drugs alone or together.
Latest
news: * On March 18, 2014, Pharma Two B has announced that it is now enrolling patients for a Phase IIb study of its combination product, P2B001, for the treatment of the early stages of Parkinson’s disease. The study will enroll a total of 150 patients, at twenty five leading clinical sites in the U.S and five sites in Israel. Pharma Two B also released the complete results of the Phase I, four-way comparative pharmacokinetics (PK) study of P2B001. Data demonstrated that there were neither pharmacokinetic interactions between the components, nor were there unexpected adverse effects. Additionally, the Cmax and AUC of each component in the combination were either equal to or smaller in comparison to the individual commercial drugs, indicating that patients were only exposed to quantities that have already been proven safe. The AUCs also signified that bioavailability is comparable to the commercial drugs, and that the drugs were available throughout the day, without high peaks.
