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 superior to currently marketed, optimally titrated, extended-release pramipexole on the Epworth Sleepiness Scale (ESS) score, which is especially important for younger people with PD leading active lives and for older people who typically cannot tolerate dopamine agonist side effects such as excessive daytime sleepiness (EDS)

REHOVOT, Israel, Aug. 28, 2023 (GLOBE NEWSWIRE) — Pharma Two B, a private, late-stage pharmaceutical company, today announced that sub-group analysis results from the Phase 3 pivotal clinical trial evaluating P2B001 are being presented at the 2023 The International Parkinson and Movement Disorder Society^® annual meeting, August 27-31, in Copenhagen, Denmark. The data are being presented as a poster presentation on Monday, August 28.

In all subgroups, the results demonstrate greater symptomatic benefit of P2B001 versus its components, and comparable efficacy with currently marketed, optimally titrated, extended-release pramipexole, yet with reduced EDS. EDS is a commonly reported side effect among people with PD, which often worsens with dopamine agonist therapy¹:

• The efficacy and safety profile of P2B001 was not significantly different in younger versus older patients (<66 vs >66 years), nor when patients were analyzed by baseline severity (≤29 vs >29 Total-Unified Parkinson’s Disease Rating Scale (UPDRS) score).
• Across all subgroups, P2B001 provided numerically greater symptomatic benefit versus its components, as assessed by Total-UPDRS, and statistically significant greater benefit in Activities of Daily Living (UPDRS Part II) versus components.
• Across all subgroups, P2B001 provided comparable symptomatic efficacy versus currently marketed, optimally titrated, extended-release pramipexole.
• P2B001 was consistently superior to extended-release pramipexole across all subgroups on ESS scores. In the full study cohort, there was significantly less daytime sleepiness compared to extended-release pramipexole at 12 weeks (-2.66 points; p≤0.001).

“This study’s findings, demonstrating greater symptomatic benefits of P2B001 as compared to its individual components in patients of all ages and disease severities, support the potential usage of P2B001 in patients with early PD. Moreover, the data showed comparable efficacy to the established extended release pramipexole regimen titrated to optimal dosage, exemplifying a potential approach to optimizing patient care, while challenging traditional paradigms,” says Drew Falconer, M.D., of the Inova Parkinson’s and Movement Disorders Center, and a trial investigator. 

Dan Teleman, CEO of Pharma Two B, adds, “We are encouraged by the consistency of the Phase 3 trial’s sub-group analyses. They reinforce our commitment to advancing P2B001 and improving the lives of people with Parkinson’s disease.”

About the Study

The international, multicenter, randomized, double-blind, parallel-group study in adult patients (35-80 years old) with early, untreated PD (<3 years from diagnosis) compared once-daily P2B001 with its individual components, as well as to optimally titrated, extended-release pramipexole (mean dose of 3.2 mg). A total of 544 participants were enrolled and randomized into the study. The primary endpoint was change from baseline to Week 12 in Total-UPDRS score (sum of Parts II and III) comparing P2B001 to its individual components. The key (first) secondary endpoint was the change from baseline to Week 12 in the ESS score comparing P2B001 to the optimized dosage of extended-release pramipexole. For the current analyses, subgroups were categorized by age (< median of 66 years vs > median of 66 years) and baseline severity (<median of 29 vs > median of 29 of Total-UPDRS (Part II+III scores)).

The data 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 PD, despite their age.

About P2B001

P2B001 is an investigational, novel, fixed-dose, extended-release combination of pramipexole and rasagiline (0.6 mg/0.75 mg), both at low doses that are not commercially available. Marketed pramipexole and rasagiline are currently indicated for the treatment of Parkinson’s disease (as monotherapy and adjunct therapy for early and more advanced patients). P2B001 is being developed for potential use as a first-line therapy for people of all ages with PD. Extended-release rasagiline is a new and proprietary formulation of rasagiline developed by Pharma Two B.

Pharma Two B owns worldwide-granted patents for P2B001 for both pharmaceutical composition and method of treatment, which are expected to remain in force until January 2033.

About Pharma Two B

Pharma Two B is a private, venture-backed, late-stage pharmaceutical company established in 2008 in Rehovot, Israel. Our mission is to improve patients’ quality of life by developing innovative, value-added combination drugs for neurological disorders with a clear unmet need, that are based on previously approved oral drugs and that offer meaningful clinical benefits, as well as improved safety and enhanced convenience through easier administration.

The company is led by a team highly experienced in PD, supported by top-tier scientific and clinical key opinion leaders, and backed by a dedicated group of investors. For more information, please visit: www.pharma2b.com.

Forward Looking Statements

Some of the statements made herein constitute forward-looking statements. These statements relate to future financial and other performance or anticipated plans and are identified by words such as “will,” “expect,” “could,” “if,” “expected,” “anticipate,” ”look forward,” “believe,” “potential,” “propose,” and “continue,” or negative variants of such terms. These and similar forward-looking statements discuss the company’s future expectations and plans. The company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the company cautions against placing undue reliance on these forward-looking statements. These statements are only estimates of future performance. Actual performance or events may not meet such expectations or estimates and may, in fact, differ materially.

Although the company believes that the expectations reflected in the forward-looking statements made herein are reasonable, the company cannot and does not guarantee future results, levels of activity, performance, or achievements. Moreover, the company does not assume any responsibility for the accuracy and completeness of such forward-looking statements in the future. The company does not plan and, subject to applicable law, undertakes no obligation to update any of the forward-looking statements made herein after the date hereof in order to conform such statements to actual results.

¹ Amara et al, J Neurol Neurosurg Psychiatry, 2017; Suzuki, J Park Dis, 2021; Avorn et al, Arch Neurol, 2005.

Contact:
Dan Teleman
CEO
Pharma Two B Ltd.
Cell. + 972-54-550-0804
email: dan@pharma2b.com 
www.pharma2b.com

U.S. media contact:
Cali Mangel
Associate Director
Cali.Mangel@calciumusa.com 
215-694-1577