Study successfully met its primary and key secondary endpoints, demonstrating superior efficacy of P2B001 compared to its individual components.
Study successfully met its primary and key secondary endpoints, demonstrating superior efficacy of P2B001 compared to its individual components
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| [15-December-2021] |
| REHOVOT, Israel, Dec. 15, 2021 /PRNewswire/ -- Pharma Two B Ltd., a privately held company developing innovative therapeutics based on reformulation and combinations of previously approved drugs for neurological indications, today announced that its Phase III double-blind, active-controlled study of P2B001 in early Parkinson’s disease (PD) successfully met its primary and key secondary endpoints. P2B001 is a novel fixed-dose combination of extended release (ER) formulations of pramipexole (0.6mg) and rasagiline (0.75mg), with both components at lower doses than their respective marketed products. In the Phase III study, P2B001 was superior to each of its individual components as measured by the change from baseline to week 12 in total Unified Parkinson’s Disease Rating Scale (UPDRS Part II and III; primary endpoint). P2B001 was superior to the pramipexole component by 2.66 points (p=0.0018) and superior to the rasagiline component by 3.30 points (p=0.0001). In addition, P2B001 demonstrated comparable efficacy to a marketed pramipexole ER (titrated to an optimal dose for each individual patient; 1.5-4.5 mg) with significantly less daytime sleepiness (somnolence), by a reduction of 2.66 points (p<0.0001) as measured by Epworth Sleepiness Scale (ESS; key secondary endpoint). P2B001 fixed dose and the marketed titrated pramipexole ER showed similar changes in total UPDRS scores after 12 weeks (-7.98 points and -8.35 points, respectively). “We are thrilled with the positive outcome of this rigorous Phase III study. There is a clear unmet medical need for an early PD treatment that can significantly improve motor symptoms and daily function, while avoiding side effects,” said Dr. Sheila Oren, M.D., M.B.A., Chief Executive Officer of Pharma Two B. “The data from this Phase III study support our view that P2B001 can provide clinical benefits comparable to higher doses of commercially available dopamine agonists, while mitigating the side effects typically associated with this class of medicine such as somnolence, orthostatic hypotension and hallucinations. This is important for PD patients of all ages and is critical for the elderly, who typically do not tolerate side effects of dopamine agonists. We would like to thank all of the study participants and investigational sites that took part in this important study”. Jeffrey Berkowitz, Chairman of the Board of Pharma Two B commented: “We believe these results are transformative for Pharma Two B and we are excited to complete the regulatory submissions and prepare for a commercial launch. Importantly, these robust results are consistent with our prior pivotal double-blind placebo-controlled Phase IIb study of P2B001 in PD, which successfully met all primary and secondary endpoints1. Based on the Phase IIb data and the Phase III topline results, we are preparing the regulatory submission for P2B001 and plan to submit a New Drug Application to the FDA in 2022.” Topline Results P2B001 Met Primary Endpoint P2B001 Met Key Secondary Endpoint Calibration of P2B001 and Pramipexole ER P2B001 Showed a Favorable Side Effect Profile Treatment-emergent adverse events (TEAE) reported in >5% of participants in any arm
Dr. Warren Olanow, Professor Emeritus of Neurology and Neuroscience at the Icahn School of Medicine at Mount Sinai in New York, commented, “The initiation of treatment of patients with Parkinson’s disease represents an area of unmet need due to the side effects associated with current treatments. Based on the data from this well-designed, rigorous, active-controlled study, P2B001 has the potential to become a leading treatment option for PD, particularly as first line therapy for early-stage patients of all ages. The results demonstrated both superior efficacy to components and a more favorable safety profile than treatment with standard doses of pramipexole. If approved, P2B001 would enable patients to be treated with an effective dose of a dopamine agonist, yet with less adverse events often seen with this class of drugs, including daytime sleepiness, orthostatic hypotension, and hallucinations. These issues can often negatively affect patients’ activities of daily living. P2B001 has the additional advantage of once-a-day administration without the need for titration.” Dr. Robert A. Hauser, M.D., M.B.A, Professor of Neurology and Director of the Parkinson’s Disease and Movement Disorders Center at the University of South Florida, commented, “The prevalence of Parkinson’s disease increases with age, and it is the fastest growing neurological disorder across the globe. With increased life expectancy and longer disease duration, patients will often require dopaminergic replacement therapies for many years. P2B001 has the potential to offer a solution that is easy to use, provides good symptomatic control and a favorable safety profile, and may reduce or delay levodopa-associated motor complications. If approved, this product will be an important new option when considering a long-term care plan for people with early-stage Parkinson’s disease.” Phase 3 Study Design About Pharma Two B Forward Looking Statements 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. Reference: Contact: U.S. investor contact: Media contact:
SOURCE Pharma Two B Ltd. |
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