The multinational study uses change from baseline to week 12 in total Unified Parkinson’s Disease Rating Scale score, defined as sum of parts II and III scores, as the primary end point.
According to a recent announcement, the final patient in the phase 3 study (NCT03329508) of P2B001 (Pharma Two B), an investigational therapy for patients with Parkinson disease (PD), has completed the study, with topline results expected to come in the fourth quarter of 2021.1
The multicenter, multinational, randomized, double-blind, double-dummy, active-controlled, parallel group study is evaluating the safety, efficacy, and tolerability of P2B001, a synergistic combination of low doses proprietary extended-release (ER) rasagiline (Azilect; Teva Pharmaceuticals) and pramipexole (Mirapex; Pharmacia & Upjohn), 2 previously approved drugs for PD. The investigational therapy is designed as a once-daily pill with no required titration to address the unmet needs of patients with early PD.
A total of 544 individuals with early PD were randomized to either P2B001 (pramipexole 0.6 mg/rasagiline 0.75 mg), 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 study spans 70 sites in North American and the EU and uses change from baseline to week 12 in total Unified Parkinson’s Disease Rating Scale (UPDRS) score as the primary end point.
"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," Sheila Oren, MD, MBA, chief executive officer, Pharma Two B, said in a statement.1 "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."1
The company previously reported topline results from a phase 2b study in 2015 that included 149 patients with early-stage PD randomized in a similar fashion. At the end of the 12-week trial period, investigators concluded that the investigational therapy met primary and secondary end points for both dose combinations.2 An improvement of 5.97 UPDRS points for the high-dose combination, leading to a significant change of 4.67 UPDRS points compared with placebo (P <.001) was observed. As for the low-dose combination group, there was an overall improvement of 5.14 UPDRS points, leading to a significant change of 3.84 UPDRS units compared with placebo (P <.001). The company also noted that the drug had a favorable safety profile.
Following the 2018 announcement of the first patients dosed in the phase 3 study, Ehud Marom, chairman, Pharma Two B, said in a statement, "following a successful round of financing totaling $35 million which includes an investment by a Chinese pharmaceutical company who purchased the rights for the product in China. This fundraising enables Pharma Two B to complete the phase 3 and expand its pipeline. We are currently focused on finding the best marketing partner to commercialize P2B001 and expand our portfolio."3