Pharma Two B Completes Enrollment in Phase IIb Study of P2B001
REHOVOT, Israel, March 4, 2015
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 fortynine patients enrolled in the study conducted at 29 clinical sites throughout the US and Israel. The results of the study, A Phase 2b, Twelveweek MultiCenter, Randomized, DoubleBlind, PlaceboControlled, 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 nonLevodopa 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."
About Pharma Two B
Pharma Two B is a drug discovery company in Israel, developing innovative products, with clinical and commercial added value, based on previously approved drugs. The company develops synergistic combinations of two drugs, acting in complementary biological mechanisms that enable the use of unique low doses, while maintaining high therapeutic benefit. The company also has a line of select generic products in new formulations. To date, Pharma Two B has completed the development and licensing out of five generic products. The company has a very experienced and dedicated management team, with both generic and innovative drug development experience. The company's chairman of the board, Mr. Ehud Marom, is credited with successfully bringing several new drugs to Phase III. He is also well known for his contribution to the successful launching of LCM and for running the global operations of the market launch of Copaxone for MS. The company's CEO is Dr. Nurit Livnah. She previously served as the V.P. of R&D at several innovative drug development companies in Israel.
Pharma Two B Ltd.
Marjie Hadad, MH Communications