Phase IIb of P2B001 follows Phase I/PK clinical study results demonstrating the sustained release profile of the product, with favorable exposure and bioavailability parameters
REHOVOT, Israel I March 18, 2014 I Pharma Two B announced today that it is now enrolling patients for a Phase IIb study of its combination product, P2B001, for the treatment of the early stages of Parkinson’s disease (PD). Pharma Two B is following the FDA’s 505(b)(2) registration pathway for P2B001.
The study titled 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 will enroll a total of 150 patients, at twenty five leading clinical sites in the U.S and five sites in Israel. C. Warren Olanow, M.D., professor of neurology and neuroscience at Mount Sinai Hospital in NY, and Karl Kieburtz, M.D., professor of neurology, public health science and environmental medicine at the University of Rochester Medical Center, are the clinical leaders of the study.
“Usually it takes a decade to bring a new drug to market. The 505(b)(2) pathway enables companies, with the right product, to fast forward through the process, saving time and money. I have successfully guided many pharmaceuticals through various regulatory processes. The 505(b)(2) route is the right approach that helps good treatments suitable for this route, come to market faster for the benefit of all. We believe P2B001 is on the right track and look forward to seeing the results of this very important study,” said pharma industry expert and chairman of Pharma Two B Mr. Ehud Marom.
Pharma Two B’s P2B001 synergistically combines two drugs already individually approved for the treatment of the early stages of Parkinson’s disease. These drugs have limited efficacy as monotherapies in low doses or require dose increases with time, which consequently lead to specific side effects. Pharma Two B has shown during the pre-clinical development stage of P2B001, that low doses of the combination components, which have very little, if any, therapeutic benefit when given individually produce a very high effect when given in combination. These benefits are due to the synergistic effects of the two components, which are further enhanced by the sustained release profile of the product, designed to provide a high therapeutic outcome with a better safety profile.
Pharma Two B also released today the complete results of the Phase I, four-way comparative pharmacokinetics (PK) study of P2B001. Data demonstrated that there were neither pharmacokinetic interactions between the components, nor were there unexpected adverse effects. Additionally, the Cmax and AUC of each component in the combination were either equal to or smaller in comparison to the individual commercial drugs, indicating that patients were only exposed to quantities that have already been proven safe. The AUCs also signified that bioavailability is comparable to the commercial drugs, and that the drugs were available throughout the day, without high peaks.
Dr. Nurit Livnah, CEO of Pharma Two B said, “We are enthusiastic about beginning the Phase IIb study anticipating that the results will further validate P2B001 as a safe and effective treatment for PD. We are looking forward to working with the very prestigious and experienced clinical teams at the various clinical sites with the goal of edging one step closer to bringing this drug to market, for the benefit of PD patients worldwide.”
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. For more information, please visit www.pharma2b.com or contact Marjie Hadad, media liaison, at marjie@netvision.net.il or at +972-54-536-5220.
SOURCE: Pharma Two B
Post Views: 24
Phase IIb of P2B001 follows Phase I/PK clinical study results demonstrating the sustained release profile of the product, with favorable exposure and bioavailability parameters
REHOVOT, Israel I March 18, 2014 I Pharma Two B announced today that it is now enrolling patients for a Phase IIb study of its combination product, P2B001, for the treatment of the early stages of Parkinson’s disease (PD). Pharma Two B is following the FDA’s 505(b)(2) registration pathway for P2B001.
The study titled 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 will enroll a total of 150 patients, at twenty five leading clinical sites in the U.S and five sites in Israel. C. Warren Olanow, M.D., professor of neurology and neuroscience at Mount Sinai Hospital in NY, and Karl Kieburtz, M.D., professor of neurology, public health science and environmental medicine at the University of Rochester Medical Center, are the clinical leaders of the study.
“Usually it takes a decade to bring a new drug to market. The 505(b)(2) pathway enables companies, with the right product, to fast forward through the process, saving time and money. I have successfully guided many pharmaceuticals through various regulatory processes. The 505(b)(2) route is the right approach that helps good treatments suitable for this route, come to market faster for the benefit of all. We believe P2B001 is on the right track and look forward to seeing the results of this very important study,” said pharma industry expert and chairman of Pharma Two B Mr. Ehud Marom.
Pharma Two B’s P2B001 synergistically combines two drugs already individually approved for the treatment of the early stages of Parkinson’s disease. These drugs have limited efficacy as monotherapies in low doses or require dose increases with time, which consequently lead to specific side effects. Pharma Two B has shown during the pre-clinical development stage of P2B001, that low doses of the combination components, which have very little, if any, therapeutic benefit when given individually produce a very high effect when given in combination. These benefits are due to the synergistic effects of the two components, which are further enhanced by the sustained release profile of the product, designed to provide a high therapeutic outcome with a better safety profile.
Pharma Two B also released today the complete results of the Phase I, four-way comparative pharmacokinetics (PK) study of P2B001. Data demonstrated that there were neither pharmacokinetic interactions between the components, nor were there unexpected adverse effects. Additionally, the Cmax and AUC of each component in the combination were either equal to or smaller in comparison to the individual commercial drugs, indicating that patients were only exposed to quantities that have already been proven safe. The AUCs also signified that bioavailability is comparable to the commercial drugs, and that the drugs were available throughout the day, without high peaks.
Dr. Nurit Livnah, CEO of Pharma Two B said, “We are enthusiastic about beginning the Phase IIb study anticipating that the results will further validate P2B001 as a safe and effective treatment for PD. We are looking forward to working with the very prestigious and experienced clinical teams at the various clinical sites with the goal of edging one step closer to bringing this drug to market, for the benefit of PD patients worldwide.”
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. For more information, please visit www.pharma2b.com or contact Marjie Hadad, media liaison, at marjie@netvision.net.il or at +972-54-536-5220.
SOURCE: Pharma Two B
Post Views: 24
