Based on positive data from a Phase IIb pivotal study suggesting that P2B001 may offer effective therapy with minimal side effects for early stage Parkinson’s Disease (PD) patients, Pharma Two B initiated a multinational Phase III clinical trial
Rehovot, Israel – February 6th, 2018 – Pharma Two B Ltd., a privately held company developing innovative therapeutics based on previously approved drugs, announced today that the first patients were dosed in the company’s Phase III study of P2B001, titled “A phase 3, twelve-week, randomized, double-blind, double-dummy, 4-arm, parallel group, multi-center, multinational study to determine the efficacy, safety and tolerability of P2B001 in subjects with early Parkinson’s disease as compared to its individual components and compared to a calibration arm of pramipexole ER”1.
A total of 525 early stage untreated PD patients will be randomized to one of four treatment arms, which include P2B001, a once daily (pramipexole 0.6mg / rasagiline 0.75 mg) combination product, pramipexole 0.6 mg once daily, rasagiline 0.75 mg once daily, and pramipexole ER titrated to optimal dose (1.5, 3.0 or 4.5mg), using a randomization scheme of 2:2:2:1, respectively. Subjects will be recruited from approximately 70 sites throughout North America and Europe.
Dr. Nurit Livnah, CEO of Pharma Two B said, “Pharma Two B is focused on successfully completing our Phase III as planned and preparing for product launch in 2020. P2B001, once approved, is expected to provide early stage Parkinson’s patients with effective treatment with an improved safety profile. We believe P2B001 has the potential to become a leading therapy for early stage PD.”
Ehud Marom, Chairman of Pharma Two B said: “Following a successful round of financing totaling $US 35 million which includes an investment by a Chinese pharmaceutical company who purchased the rights for the product in China. This fundraising enables Pharma Two B to complete the Phase III and expand its pipeline. We are currently focused on finding the best marketing partner to commercialize P2B001 and expand our portfolio.”
About Pharma Two B
Pharma Two B is a drug development company focused on developing innovative products, with clinical and commercial added value, based on previously approved drugs. The company develops synergistic combinations that act in complementary biological mechanisms. It enables the use of unique low doses, while maintaining high therapeutic benefit. In addition to its internal products in development the company is looking to expand its pipeline by in-licensing projects that focus on treatment of central nervous system disease. For more information, please visit: www.pharma2b.com
https://clinicaltrials.gov/ct2/show/NCT03329508
Contact:
Dr. Nurit Livnah CEO
+972 54 301 3547
nurit@167.99.197.46