We are pleased to announce the completion of the last patient visit in this Phase III study, which represents an important milestone for Pharma Two B and our P2B001 clinical program.
REHOVOT, Israel, Sept. 13, 2021 (GLOBE NEWSWIRE) — Pharma Two B Ltd., a privately held company developing innovative therapeutics based on previously approved drugs for Parkinson disease (PD), today announced that the last patient in its multinational Phase III study of P2B001 in early PD has now completed the study. Top line results from the study are expected in the fourth quarter of 2021.
P2B001 is a synergistic combination of low doses proprietary extended-release (ER) rasagiline (monoamine oxidase-B inhibitor) and pramipexole (dopamine agonist), both approved drugs for PD, designed to address an unmet medical need, being highly effective with minimal side effects, especially for early-stage patients. It has been formulated in a convenient, once-daily pill, with no titration required.
“We are pleased to announce the completion of the last patient visit in this Phase III study, which represents an important milestone for Pharma Two B and our P2B001 clinical program,” said Dr. Sheila Oren, M.D., M.B.A., Chief Executive Officer of Pharma Two B. “We look forward to reviewing the top line results and anticipate that if approved, P2B001 will offer meaningful clinical benefits for early-stage PD patients, also for older patients who cannot tolerate the associated side effects of the current available drugs. We are very grateful to the clinical investigators, trial participants and their families for their time and commitment.”
Phase III Study Design
This is a multi-center, multinational, randomized, double-blind, double-dummy, active-controlled, parallel group study to determine the safety, tolerability and efficacy of P2B001 compared to its individual components and to a calibration arm of pramipexole ER in subjects with early Parkinson’s disease. A total of 544 subjects were randomized to one of the following four treatment arms: P2B001, a once daily (pramipexole 0.6 mg / rasagiline 0.75 mg) combination product, pramipexole 0.6 mg once daily, rasagiline 0.75 mg once daily, and pramipexole ER titrated to optimal dose (1.5 to 4.5 mg). The primary endpoint is the change from baseline to week 12 in total Unified Parkinson’s Disease Rating Scale (UPDRS) score (defined as sum of parts II and III scores). The study is being conducted at 70 sites in North America and the EU. For more information, refer to ClinicalTrials.gov Identifier: NCT03329508.
About Pharma Two B
harma Two B is a clinical-stage pharmaceutical company that is developing differentiated and value-added products, based on reformulation of previously approved drugs. The Company’s aim is to improve efficacy, safety and delivery profiles while addressing unmet medical needs and decreasing the timeline to FDA approval via the 505(b)(2) regulatory pathway. The Company’s lead product P2B001 is being investigated as a treatment for early-stage Parkinson’s disease (PD). P2B001 is a once daily, no titration, therapy for patients with PD to obtain good clinical efficacy with a low risk of side effects, as shown in the Phase IIb clinical trial. Pharma Two B is led by a highly experienced team, supported by prominent scientific and clinical key opinion leaders, and backed by a dedicated group of investors. For more information, please visit: www.pharma2b.com.
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