Pharma Two B Announces Publication of Positive Phase 3 Study Results of P2B001, an Investigational Treatment for Early Parkinson’s Disease, in Movement Disorders

Demonstrated that P2B001 provides benefits comparable with commercially used doses of marketed pramipexole-ER (PramiER) while minimizing associated daytime sleep-related and dopaminergic side effects associated P2B001 provided superior efficacy on motor symptoms and activities of daily living, compared to each of its individual components The convenient dosing of P2B001, as a no-titration, once-daily single pill, may … Read more

Pharma Two B to Present Additional Phase 3 Positive Results of P2B001, a once-daily, fixed-dose combination of low-dose pramipexole and low-dose rasagiline, at 2023 International Congress of Parkinson’s Disease and Movement Disorders®

Sub-group analyses of patients with early Parkinson’s disease (PD) at different age groups or baseline disease severities who were treated with P2B001 showed consistently greater symptomatic control versus its components (pramipexole 0.6 mg and rasagiline 0.75 mg) and comparable efficacy to currently marketed, optimally titrated, extended-release pramipexole Data analysis also showed P2B001 to be consistently … Read more

Pharma Two B to Present Additional Positive Results from P2B001 Phase 3 Trial at 2023 American Academy of Neurology Annual Meeting

Results showed P2B001, a once-daily fixed-dose combination of low dose pramipexole and low dose rasagiline, showed comparable efficacy to marketed optimally titrated pramipexole, with significantly reduced sleep-related and dopaminergic side effects Data analysis also confirmed patients treated with P2B001 developed significantly less new-onset excessive daytime sleepiness when compared to marketed pramipexole REHOVOT, Israel, April 23, … Read more

Pharma Two B Presents Positive Efficacy and Safety Data of P2B001 from Phase 3 Trial at the MDS International Congress of Parkinson’s Disease and Movement Disorders®

P2B001 is a novel proprietary fixed-dose combination of extended-release (ER) formulations of low doses of pramipexole and rasagiline; both doses are not currently available on the market Phase 3 data support the potential of P2B001 as a first-line, once-daily treatment for people with Parkinson’s disease (PD), that may offer effective symptomatic control with significantly less … Read more

Pharma Two B Presents Late-Breaker Abstract on Positive Efficacy and Safety Data of P2B001 from Phase 3 Trial at American Academy of Neurology (AAN) Annual Meeting

REHOVOT, Israel, April 05, 2022 (GLOBE NEWSWIRE) — Pharma Two B Ltd., a privately held company developing innovative therapeutics based on reformulation and combinations of previously approved drugs for neurological indications, today announced that the efficacy and safety data from its recently completed Phase 3, randomized controlled trial of P2B001 in the management of early Parkinson’s … Read more

Advances in Therapy publishes Pharma Two B’s review paper, “P2B001 (extended release pramipexole and rasagiline): A new treatment option in development for Parkinson’s disease”

Robert A. Hauser, Nir Giladi, Werner Poewe, Jonathan Brotchie, Hadas Friedman, Sheila Oren & Pninit Litman Published: 10 March 2022 Advances in Therapy DOI: 10.1007/s12325-022-02097-2 Abstract Despite levodopa’s superior efficacy in reducing the motor symptoms of Parkinson’s disease (PD), its risk to induce motor complications requires consideration of the pros and cons of initiating treatment … Read more

Pharma Two B Announces Positive Topline Results from its Pivotal Phase III Study of P2B001 in Early Parkinson’s Disease

Study successfully met its primary and key secondary endpoints, demonstrating superior efficacy of P2B001 compared to its individual components P2B001 showed comparable efficacy to a marketed extended release (ER) pramipexole with significantly less daytime sleepiness and a superior safety profile Topline results support P2B001’s potential as a first line treatment for people with early Parkinson’s … Read more

Pharma Two B Announces Licensing and Investment Agreement with Myung In Pharm (MIP) for P2B001 in South Korea

Myung In Pharm to lead registration, commercialization and manufacturing of P2B001 in South Korea Myung In Pharm made a $5 million equity investment in Pharma Two B REHOVOT, Israel, Nov. 18, 2021 (GLOBE NEWSWIRE) — Pharma Two B Ltd., a privately held company developing innovative therapeutics based on reformulation of previously approved drugs for neurological … Read more