Pharma Two B announced today that enrollment has been completed in the company's Phase IIb study of P2B001 for the treatment of early stage Parkinson's disease. One hundred and forty-nine patients enrolled in the study conducted at 29 clinical sites throughout the US and Israel. The results of the study, 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, are anticipated in a few months.
An estimated seven to ten million people worldwide are living with Parkinson's disease (PD), a degenerative disorder of the central nervous system. Symptoms include: tremors, slowed movement (bradykinesia), rigid muscles, impaired posture and balance, loss of automatic movements, speech changes and writing changes.
The current gold standard treatment for PD is Levodopa, but long term use requires dose increases that lead to severe side effects over time including dyskinesia (uncontrolled movement) and off periods (hours of time when the patient suffers from a debilitating decrease in mobility). To delay this situation, physicians often prescribe milder drugs at the early stage of the illness. Though safer, given in low doses, these drugs are not as effective as Levodopa. Moreover, they too require dose increases over time, which also result in unwanted side effects.
"Pharma Two B's P2B001 synergistically combines two non-Levodopa drugs already individually approved for the treatment of the early stages of Parkinson's disease, in an adapted, sustained release profile. Given as low dose monotherapies, the effect of these drugs is limited. However, our preclinical studies indicate that due to their strong synergy, a low dose combination of these two drugs leads to a significant therapeutic effect, which is further enhanced when these drugs are administered in an adapted release profile enabling them to work in tandem for an extended period of time. Our observations also indicate that the emerging safety profile is very positive. We hope to reconfirm these assessments in the coming months with the final outcomes of the current Phase IIb study," said Pharma Two B CEO Dr. Nurit Livnah.
"Identifying improved solutions for PD is an important interest of the pharmaceutical industry and the medical community. We are doing our part to answer this clear and unmet need," said chairman of the board of Pharma Two B Mr. Ehud Marom. "Assuming the Phase IIb study yields positive data, we plan to immediately begin the Phase III clinical trial of P2B001, and, following the 505(b)(2) pathway, bring this important therapy to market as soon as possible. This is our goal."