P2B Vision & Mission
Pharma Two B is a private, late clinical-stage pharmaceutical company established in 2007 in Rehovot, Israel.
Our mission is to improve patients’ quality of life by developing innovative, value-added combination drugs for neurological disorders, with a clear unmet need, that are based on previously approved oral drugs and may offer:
►Meaningful clinical benefits
►Enhanced convenience & administration
Our highly experienced team, supported by top tier scientific and clinical key opinion leaders, and backed by a dedicated group of investors led the development of proprietary formulations that enhance the efficacy and safety of previously approved drugs.
Pharma Two B aims to utilize the shortened FDA approval timelines via the US 505(b)(2) regulatory pathway, reserved for candidates, who among other criteria, may be a novel combination of two known active ingredients and demonstrate a significant clinical advantage over each active ingredient as is currently marketed as monotherapy. This pathway allows relying partially on safety and efficacy data of previously approved drugs that saves time, money and reduces development risk.
Our lead investigational product candidate, P2B001, has completed successfully both Phase IIb and Phase III studies investigating its efficacy and safety as a once-daily, no-titration treatment for early-stage Parkinson’s disease (PD). The low dose combination of pramipexole (dopamine agonist) and rasagiline (MAO-B inhibitor), both as extended-released formulations, achieved statistically significant clinical efficacy and an improved safety profile with a low incidence of serious side effects. A New Drug Application (NDA) submission to the FDA is being prepared.
Pharma Two B owns strong IP for P2B001, with both pharmaceutical composition and method of treatment patents granted worldwide in force until Jan 2033.