Pharma Two B is following the US Food and Drug Administration’s (FDA) 505(b)(2) registration pathway for P2B001.
The study titled A Phase 2B, 12-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 US and five sites in Israel.
Dr C. Warren Olanow, professor of neurology and neuroscience at Mount Sinai Hospital in New York, and Dr Karl Kieburtz, professor of neurology, public health science and environmental medicine at the University of Rochester Medical Center, are the clinical leaders of the study.
Pharma Two B’s P2B001 synergistically combines two drugs already individually approved for the treatment of the early stages of Parkinson’s disease.
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.
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.
Pharma Two B CEO Dr Nurit Livnah noted the company is enthusiastic about beginning the Phase IIb study anticipating that the results will further validate P2B001 as a safe and effective treatment for PD.
"We are looking forward to working with the very prestigious and experienced clinical teams at the various clinical sites with the goal of edging one step closer to bringing this drug to market, for the benefit of PD patients worldwide," Dr Livnah added.