Pharma Two B to Present Additional Positive Results from P2B001 Phase 3 Trial at… – Press Release

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  • 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, 2023 (GLOBE NEWSWIRE) — Pharma Two B, a private, venture-backed, late-stage pharmaceutical company, today announced that additional results from the Phase 3 pivotal clinical trial evaluating P2B001, will be presented at the 2023 American Academy of Neurology (AAN) Annual Meeting, April 22-27 in Boston, MA. The data are being presented as an oral (Abstract 3733) and poster (Abstract 2396) presentation.

The data in both presentations are consistent with the positive Phase 3 topline efficacy and safety results presented previously, reemphasizing the potential of P2B001, if approved, to offer a new treatment approach for people with early Parkinson’s disease (PD). Pharma Two B plans to submit a New Drug Application (NDA) for P2B001 to the U.S. Food and Drug Administration (FDA) in 2023.

The Phase 3 trial was a global, multi-center, double-blind, parallel group design that enrolled 544 treatment naïve patients with PD (Hoehn-Yahr <3). The primary endpoint was the change from baseline to week 12 in total Unified Parkinson’s Disease Rating Scale (UPDRS) for P2B001 versus its individual components. The key secondary endpoint compared the change from baseline in Epworth Sleepiness Scale (ESS) for P2B001 versus commercial pramipexole-ER (Prami-ER). Excessive daytime sleepiness (EDS) is a commonly reported side effect among people with PD, which often worsens with dopamine agonist (DA) treatmenti.

“The results of this Phase 3 trial represent positive news for newly diagnosed PD patients, as there has been a clear unmet need for an initial,…

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