Pharma Two B Ltd. today announced that positive efficacy and safety data from its recently completed randomized, controlled Phase 3 trial of investigational P2B001.
- P2B001 is a novel proprietary fixed-dose combination of extended-release (ER) formulations of low doses of pramipexole and rasagiline; both doses are not currently available on the market
- Phase 3 data support the potential of P2B001 as a first-line, once-daily treatment for people with Parkinson’s disease (PD), that may offer effective symptomatic control with significantly less daytime sleepiness and fewer dopaminergic adverse events
REHOVOT, Israel, Sept. 15, 2022 (GLOBE NEWSWIRE) -- Pharma Two B Ltd. today announced that positive efficacy and safety data from its recently completed randomized, controlled Phase 3 trial of investigational P2B001 in the management of early PD will be presented at the MDS International Congress of Parkinson’s Disease and Movement Disorders® Sept. 15-18 in Madrid. The data will be presented in various formats, including a guided poster tour, an e-poster and video on the MDS Congress virtual platform, and publication in the Movement Disorders journal supplement.
“We are pleased that the positive data from our Phase 3 study of P2B001 in early Parkinson’s patients were selected for presentation at the MDS International Congress,” said Dr. Sheila Oren, M.D., M.B.A., Chief Executive Officer of Pharma Two B. “The data show P2B001’s potential to offer patients with early PD a treatment option that can significantly improve motor symptoms and daily function, while reducing common side effects associated with dopamine agonists, such as daytime sleepiness, orthostatic hypotension, and hallucinations. If approved, once daily P2B001 may offer a new approach for initiating PD therapy. We are currently preparing a regulatory market approval filing for P2B001 with the U.S. Food and Drug Administration (FDA).”
Dr. Warren Olanow, Professor Emeritus in the Departments of Neurology and Neuroscience at the Icahn School of Medicine at Mount Sinai in New York and CEO of Clintrex Research Corporation, added, “P2B001 showed superior efficacy to each of its individual components in the trial and comparable efficacy to marketed doses of Pramipexole ER, but with reduced adverse events related to dopaminergic side effects and sleepiness, and with less worsening on the Epworth Sleepiness Scale (ESS). P2B001 has the potential to be an important first line treatment option for patients with early Parkinson’s disease. If approved, P2B001 may represent a new treatment option for initiating treatment of PD patients that provides benefits comparable to pramipexole ER but minimizes the dopaminergic side effects and daytime sleepiness seen with this class of drugs. Further, the drug is administered once a day and does not require titration.”
Phase 3 Study Results
The multicenter, randomized, double-blind, parallel group, Phase 3 study enrolled 544 patients with Parkinson’s disease to determine the efficacy and safety of P2B001 given once a day compared to its individual components in patients with early untreated PD and compared to a calibration arm of marketed pramipexole ER tablets. Eligible patients, aged 35-80, were randomized (2:2:2:1) to 12-weeks treatment with P2B001, pramipexole ER 0.6mg (component 1), rasagiline ER 0.75mg (component 2) or marketed pramipexole-ER, titrated to optimal dose (mean dose 3.2 mg).
The primary endpoint compared the change from baseline to week 12 in UPDRS (Unified Parkinson’s Disease Rating Scale) total scores for P2B001 versus its individual components. The key secondary endpoint compared the change from baseline in Epworth Sleepiness Scale (ESS) for P2B001 versus pramipexole-ER.
The results showed that P2B001 was superior to each of its individual components in total UPDRS and in individual Motor and Activities of Daily Living (ADL) UPDRS scores. P2B001 showed symptomatic benefits comparable to optimal doses of marketed titrated pramipexole ER, yet with significantly less daytime sleepiness as measured by the ESS, and fewer dopaminergic side effects. For more information on the study, refer to ClinicalTrials.gov Identifier: NCT03329508
| MDS Oral Abstract Presentation Details: | |
| Abstract Title: | “P2B001 in the management of untreated PD. Results from a randomized, double-blind, double-dummy controlled trial.” |
| Abstract Number: | 750 |
| Abstract Category: | Parkinson’s Disease: Clinical Trials |
| Guided Poster Tour: | GPT 6 |
| Where: | France Gallery, Madrid Marriott Auditorium Hotel and Conference Center |
| When: | Friday, Sept. 16, 2022, from 1-3 CET (7 - 9 a.m. ET) |
| Who: | Dr. Warren Olanow, Professor Emeritus of Neurology and Neuroscience at the Icahn School of Medicine at Mount Sinai in New York |
| General Poster Viewing: | Sept. 15-18, 2022, 9-18 CET |
| Publication in Movement Disorderswebsite: Sept. 15, 2022 | |
About Pharma Two B
Pharma Two B is a private, late clinical-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.
Pharma Two B aims to utilize the FDA’s 505(b)(2) regulatory approval pathway reserved for drug candidates, which among other criteria, may be a novel combination of two known active ingredients and demonstrate a significant clinical advantage over each individual active ingredient as is currently marketed as monotherapy. This pathway allows relying partially on safety and efficacy data of previously approved drugs that can save time, money and reduce development risk.
Our lead investigational product candidate, P2B001, has successfully completed Phase 2b and Phase 3 studies investigating its efficacy and safety as a once-daily, no-titration treatment for early-stage Parkinson’s disease. A New Drug Application (NDA) submission to the FDA is being prepared.
Pharma Two B owns worldwide granted patents for both pharmaceutical composition and method of treatment with P2B001, in force until Jan 2033.
The company is led by a highly experienced team, 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.
Contact:
Irit Aish
Chief Commercial Officer
irita@Pharma2b.com
U.S. media contact:
Ingrid Mezo
Evoke Canale Communications
301-473-2881
ingrid.mezo@evokegroup.com
