Advancing Parkinson’s Disease Treatment: P2B001 Offers Promising Safety Profile in Early PD Patients

• P2B001, a novel once-daily combination therapy, uniquely merges extended-release pramipexole and rasagiline in low doses, targeting Parkinson’s Disease (PD) with enhanced efficacy and minimized side effects.
• The analysis presented by Pharma Two B highlighted P2B001’s impressive safety and tolerability profile compared to placebo and commercially available ER-pramipexole (PramiER), alongside its superior efficacy in addressing motor fluctuations.

At the American Academy of Neurology conference 2024, Pharma Two B presented an integrated analysis of Phase II (NCT01968460) and Phase III (NCT03329508) trials showcasing the safety and tolerability profile of P2B001 in patients with early Parkinson’s disease (PD). P2B001, a once-daily combination of low-dose, extended-release formulations of pramipexole and rasagiline, demonstrated promising results compared to both placebo and commercially available ER-pramipexole (PramiER). Among 199 patients receiving P2B001, 59% reported at least one treatment-related adverse event (AE), predominantly mild to moderate in intensity, with no serious AEs reported. Common AEs included nausea, somnolence, fatigue, dizziness, and insomnia, while dopaminergic AEs occurred less frequently with P2B001 compared to PramiER. Importantly, there was no worsening in PD-related symptoms, highlighting P2B001’s potential as a convenient and well-tolerated first-line treatment option for early PD patients.

Additionally, the integrated analysis revealed that the frequency of dopaminergic treatment-emergent adverse events (TEAEs) was lower with P2B001 compared to PramiER, with 45.7% versus 66.2% respectively. Notably, while dopaminergic TEAEs tended to emerge within the first four weeks of P2B001 treatment, the increased frequency persisted with PramiER. Moreover, in the Phase III study, there was no observed worsening from baseline in the QUIP-RS-Total-Score for either the P2B001 or PramiER groups, with changes of -1.49 and -0.66, respectively. These findings underscore P2B001’s potential to provide not only symptomatic relief but also a superior safety profile, offering patients a viable and convenient treatment option for early Parkinson’s disease.

Pharma Two B is taking significant strides to address the unmet needs in early Parkinson’s disease within the realm of movement disorders. Their groundbreaking therapy, P2B001, represents a pivotal advancement in this field. By combining low-dose extended-release formulations of pramipexole and rasagiline into a once-daily regimen, Pharma Two B is revolutionizing the treatment landscape for Parkinson’s disease patients. This innovative approach not only offers superior efficacy compared to its individual components but also stands on par with commercially available dopamine agonists, without the burden of excessive daytime sleepiness often associated with traditional treatments.

Conclusion

The integrated analysis of Phase II and III studies presented by Pharma Two B underscores the potential of P2B001 as a groundbreaking treatment option for early Parkinson’s disease (PD) patients. P2B001 presents a compelling option for individuals with early Parkinson’s disease, offering a convenient, once-daily regimen with favorable safety and tolerability profiles in comparison to commercially available PramiER. Adverse events associated with P2B001 were predominantly mild to moderate, with no concerns related to impulse control disorders observed.