Phase 3 Trial of P2B001 for Early-Stage Parkinson's Disease Begins With First Patients Receiving First Dose

Wednesday, February 07, 2018

The drug P2B001(Pharma Two B) is a combination product of pramipexole 0.6mg and rasagiline 0.75 mg given together once daily. Rasagiline is a monoamine oxidase inhibitor used to treat Parkinson’s disease (PD) alone or, more commonly, as an adjunct to treatment with levodopa. Pramipexole is a dopamine agonist often used in early-stage PD treatment with the goal of postponing initiation of levodopa treatment due to the significant complications of prolonged use of levodopa.

Based on positive results from a phase 2b pivotal study that suggested efficacy and minimal side effects for P2B001 in early-stage PD, Pharma Two B designed and initiated a multinational phase 3 trial and today announced that the first patients in that trial had received their first doses of P2B001.

The study is a twelve-week long, randomized, double-blind, double dummy, 4-arm, parallel study that explores the efficacy, tolerability, and safety of P2B001for patients with early-stage PD compared to rasagiline alone, pramipexole along, and pramipexole ER titrated to an optimal dose. Investigators from 70 international sites will enroll 525 untreated patients with early-stage PD and randomize them into one of the four treatment arms in the study.

Dr. Nurit Livnah, CEO of Pharma Two B said, "Pharma Two B is focused on successfully completing our phase 3 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 3 and expand its pipeline. We are currently focused on finding the best marketing partner to commercialize P2B001 and expand our portfolio."

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