Pharma Two B plans to initiate P2B001 Phase II study in Parkinson's disease

Pharma Two B announced today it is planning a Phase II study of its new combination therapy, P2B001, in development as a treatment for the early stages of Parkinson's disease. Assuming regulatory approval and the necessary financing, the company plans to commence the Phase II trial in Q4 2011. This activity follows a recently completed Phase I trial of P2B001 whereby a very encouraging safety profile was demonstrated. Following a US regulatory pathway of 505(b)2 submission, intended for new products based on previously approved drugs, the combination could be approved in as little as three years.

"Today, the gold standard for treating Parkinson's is L-Dopa, a very effective drug, but one, that with continued use, requires dose adjustments that lead to severe side effects over time. In an attempt to delay the administration of harsh treatment, many physicians tend to prescribe milder drugs for early stage Parkinson's patients. These drugs are safer, but their efficacy is often limited, especially in low doses," said Dr. Nurit Livnah, CEO of Pharma Two B. "Pharma Two B's P2B001 synergistically combines two drugs already individually approved for the treatment of the early stages of Parkinson's, but which have limited efficacy as monotherapies in low doses, or require dose increases with time, which also lead to specific side effects. Pharma Two B has optimized the doses of these two drugs in such a way that, when given individually, in the same low dose, there is very little, if any, clinical benefit. However, when given in combination, as shown in preclinical studies, the effect is very high. The company also developed sustained release formulations for the components, releasing both drugs throughout the day, thereby allowing maximum synergy between them. Pre-clinical results also show that this release profile increases the efficacy of the combination by up to 50%. We are anticipating like results from the upcoming Phase II study."

In the past few months, Pharma Two B sponsored a four-way comparative pharmacokinetics study to test the absorption, metabolism and elimination in humans of its P2B001 in comparison to the commercially available components. The study, which was conducted in Israel, also reviewed possible interactions between the two drugs. The results of the study were very encouraging regarding the PK properties and the safety profile of the combination product.

Dr. Livnah continued, "P2B001 has very good prospects to provide prolonged, safe and effective treatment of Parkinson's disease, using low doses of the drugs, while maintaining very high efficacy, due to remarkable synergy and the adapted release profile. We are looking forward to sharing more information regarding our plans at ILSI/BioMed 2011 next week in Israel."

"The 505B2 pathway saves the sponsors and the regulatory authorities time and money, in developing improved innovative products based on previously approved drugs. This is a very advantageous process for small companies. It allows them to lead clinical development efficiently and with relatively limited costs. It also offers potential partners a product with a human safety and efficacy proof of concept, a significantly lower risk and a shorter time to market," said Mr. Ehud Marom, pharma industry veteran and chairman of the board of Pharma Two B.