Parkinson s Disease (PD), a neurodegenerative disorder of the central nervous system, currently affects one million people in the United States, and an estimated 50,000 60,000 new cases of PD are diagnosed each year.
The current standard treatment for PD is Levodopa, but long-term use of Levodopa can result in severe adverse effects over time, including dyskinesia (uncontrolled involuntary movement) and return periods of PD symptoms. For this reason, physicians prescribe other drugs in the early stages after PD diagnosis to delay Levodopa however these drugs are not as safe or as effective as Levodopa. This means there is an unmet medical need for a safe and effective treatment drug for early PD.
And now, the results of Pharma Two B Ltd. s Phase IIb pivotal study of a combination treatment known as P2B001 have shown success. P2B001 is a combination of two PD drugs low dose pramipexole and low dose rasagiline administered as a sustained release formulation.
The study, titled A Phase IIb, 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, included 149 patients and specifically showed:
- Overall improvement of 5.97 UPDRS points for the high dose combination, leading to a significant change of 4.67 UPDRS points compared to placebo.
- Overall improvement of 5.14 UPDRS points in the low dose combination, leading to a significant change of 3.84 UPDRS units compared to placebo.
- A favorable safety profile
The Unified Parkinson Disease Rating Scale (UPDRS) is a rating tool to follow the longitudinal course of PD. It is made up of three sections: Mentation, Behavior, and Mood; Activities of Daily Living; and Motor, which are all evaluated by interview.
"We are now thrilled to confirm similar results in our Phase IIb clinical study, showing that Pharma Two B's combination product has a significant anti-Parkinsonian effect in both low doses tested, with a very good safety profile. Moreover, P2B001 provided benefits similar to those observed with the higher doses currently prescribed to PD patients. This means that with P2B001, PD patients may be able to achieve clinical benefits comparable to current treatments but with lower doses and less risk of serious side effects, said Pharma Two B CEO, Dr. Nurit Livnah.