Pharma Two B Ltd., a privately held company developing innovative therapeutics based on reformulation and combinations of previously approved drugs for neurological indications, announced that its Phase III double-blind, active-controlled study of P2B001 in early Parkinson’s disease (PD) successfully met its primary and key secondary endpoints.
P2B001 is a novel fixed-dose combination of extended release (ER) formulations of pramipexole (0.6mg) and rasagiline (0.75mg), with both components at lower doses than their respective marketed products. In the Phase III study, P2B001 was superior to each of its individual components as measured by the change from baseline to week 12 in total Unified Parkinson’s Disease Rating Scale (UPDRS Part II and III; primary endpoint). P2B001 was superior to the pramipexole component by 2.66 points (p=0.0018) and superior to the rasagiline component by 3.30 points (p=0.0001).
In addition, P2B001 demonstrated comparable efficacy to a marketed pramipexole ER (titrated to an optimal dose for each individual patient; 1.5-4.5 mg) with significantly less daytime sleepiness (somnolence), by a reduction of 2.66 points (p<0.0001) as measured by Epworth Sleepiness Scale (ESS; key secondary endpoint). P2B001 fixed dose and the marketed titrated pramipexole ER showed similar changes in total UPDRS scores after 12 weeks (-7.98 points and -8.35 points, respectively).
“We are thrilled with the positive outcome of this rigorous Phase III study. There is a clear unmet medical need for an early PD treatment that can significantly improve motor symptoms and daily function, while avoiding side effects,” said Dr. Sheila Oren, M.D., M.B.A., Chief Executive Officer of Pharma Two B. “The data from this Phase III study support our view that P2B001 can provide clinical benefits comparable to higher doses of commercially available dopamine agonists, while mitigating the side effects typically associated with this class of medicine such as somnolence, orthostatic hypotension and hallucinations. This is important for PD patients of all ages and is critical for the elderly, who typically do not tolerate side effects of dopamine agonists. We would like to thank all of the study participants and investigational sites that took part in this important study”.