• Resources
  • Blog
  • Journalists
  • Log In
  • Sign Up
  • Data Privacy
  • Send a Release
Cision PR Newswire: news distribution, targeting and monitoring home
  • News
  • Products
  • Contact

 

When typing in this field, a list of search results will appear and be automatically updated as you type.

Searching for your content...

No results found. Please change your search terms and try again.
  • News in Focus
      • Browse News Releases

      • All News Releases
      • All Public Company
      • English-only
      • News Releases Overview

      • Multimedia Gallery

      • All Multimedia
      • All Photos
      • All Videos
      • Multimedia Gallery Overview

      • Trending Topics

      • All Trending Topics
  • Business & Money
      • Auto & Transportation

      • All Automotive & Transportation
      • Aerospace, Defense
      • Air Freight
      • Airlines & Aviation
      • Automotive
      • Maritime & Shipbuilding
      • Railroads and Intermodal Transportation
      • Supply Chain/Logistics
      • Transportation, Trucking & Railroad
      • Travel
      • Trucking and Road Transportation
      • Auto & Transportation Overview

      • View All Auto & Transportation

      • Business Technology

      • All Business Technology
      • Blockchain
      • Broadcast Tech
      • Computer & Electronics
      • Computer Hardware
      • Computer Software
      • Data Analytics
      • Electronic Commerce
      • Electronic Components
      • Electronic Design Automation
      • Financial Technology
      • High Tech Security
      • Internet Technology
      • Nanotechnology
      • Networks
      • Peripherals
      • Semiconductors
      • Business Technology Overview

      • View All Business Technology

      • Entertain­ment & Media

      • All Entertain­ment & Media
      • Advertising
      • Art
      • Books
      • Entertainment
      • Film and Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • Entertain­ment & Media Overview

      • View All Entertain­ment & Media

      • Financial Services & Investing

      • All Financial Services & Investing
      • Accounting News & Issues
      • Acquisitions, Mergers and Takeovers
      • Banking & Financial Services
      • Bankruptcy
      • Bond & Stock Ratings
      • Conference Call Announcements
      • Contracts
      • Cryptocurrency
      • Dividends
      • Earnings
      • Earnings Forecasts & Projections
      • Financing Agreements
      • Insurance
      • Investments Opinions
      • Joint Ventures
      • Mutual Funds
      • Private Placement
      • Real Estate
      • Restructuring & Recapitalization
      • Sales Reports
      • Shareholder Activism
      • Shareholder Meetings
      • Stock Offering
      • Stock Split
      • Venture Capital
      • Financial Services & Investing Overview

      • View All Financial Services & Investing

      • General Business

      • All General Business
      • Awards
      • Commercial Real Estate
      • Corporate Expansion
      • Earnings
      • Environmental, Social and Governance (ESG)
      • Human Resource & Workforce Management
      • Licensing
      • New Products & Services
      • Obituaries
      • Outsourcing Businesses
      • Overseas Real Estate (non-US)
      • Personnel Announcements
      • Real Estate Transactions
      • Residential Real Estate
      • Small Business Services
      • Socially Responsible Investing
      • Surveys, Polls and Research
      • Trade Show News
      • General Business Overview

      • View All General Business

  • Science & Tech
      • Consumer Technology

      • All Consumer Technology
      • Artificial Intelligence
      • Blockchain
      • Cloud Computing/Internet of Things
      • Computer Electronics
      • Computer Hardware
      • Computer Software
      • Consumer Electronics
      • Cryptocurrency
      • Data Analytics
      • Electronic Commerce
      • Electronic Gaming
      • Financial Technology
      • Mobile Entertainment
      • Multimedia & Internet
      • Peripherals
      • Social Media
      • STEM (Science, Tech, Engineering, Math)
      • Supply Chain/Logistics
      • Wireless Communications
      • Consumer Technology Overview

      • View All Consumer Technology

      • Energy & Natural Resources

      • All Energy
      • Alternative Energies
      • Chemical
      • Electrical Utilities
      • Gas
      • General Manufacturing
      • Mining
      • Mining & Metals
      • Oil & Energy
      • Oil and Gas Discoveries
      • Utilities
      • Water Utilities
      • Energy & Natural Resources Overview

      • View All Energy & Natural Resources

      • Environ­ment

      • All Environ­ment
      • Conservation & Recycling
      • Environmental Issues
      • Environmental Policy
      • Environmental Products & Services
      • Green Technology
      • Natural Disasters
      • Environ­ment Overview

      • View All Environ­ment

      • Heavy Industry & Manufacturing

      • All Heavy Industry & Manufacturing
      • Aerospace & Defense
      • Agriculture
      • Chemical
      • Construction & Building
      • General Manufacturing
      • HVAC (Heating, Ventilation and Air-Conditioning)
      • Machinery
      • Machine Tools, Metalworking and Metallurgy
      • Mining
      • Mining & Metals
      • Paper, Forest Products & Containers
      • Precious Metals
      • Textiles
      • Tobacco
      • Heavy Industry & Manufacturing Overview

      • View All Heavy Industry & Manufacturing

      • Telecomm­unications

      • All Telecomm­unications
      • Carriers and Services
      • Mobile Entertainment
      • Networks
      • Peripherals
      • Telecommunications Equipment
      • Telecommunications Industry
      • VoIP (Voice over Internet Protocol)
      • Wireless Communications
      • Telecomm­unications Overview

      • View All Telecomm­unications

  • Lifestyle & Health
      • Consumer Products & Retail

      • All Consumer Products & Retail
      • Animals & Pets
      • Beers, Wines and Spirits
      • Beverages
      • Bridal Services
      • Cannabis
      • Cosmetics and Personal Care
      • Fashion
      • Food & Beverages
      • Furniture and Furnishings
      • Home Improvement
      • Household, Consumer & Cosmetics
      • Household Products
      • Jewelry
      • Non-Alcoholic Beverages
      • Office Products
      • Organic Food
      • Product Recalls
      • Restaurants
      • Retail
      • Supermarkets
      • Toys
      • Consumer Products & Retail Overview

      • View All Consumer Products & Retail

      • Entertain­ment & Media

      • All Entertain­ment & Media
      • Advertising
      • Art
      • Books
      • Entertainment
      • Film and Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • Entertain­ment & Media Overview

      • View All Entertain­ment & Media

      • Health

      • All Health
      • Biometrics
      • Biotechnology
      • Clinical Trials & Medical Discoveries
      • Dentistry
      • FDA Approval
      • Fitness/Wellness
      • Health Care & Hospitals
      • Health Insurance
      • Infection Control
      • International Medical Approval
      • Medical Equipment
      • Medical Pharmaceuticals
      • Mental Health
      • Pharmaceuticals
      • Supplementary Medicine
      • Health Overview

      • View All Health

      • Sports

      • All Sports
      • General Sports
      • Outdoors, Camping & Hiking
      • Sporting Events
      • Sports Equipment & Accessories
      • Sports Overview

      • View All Sports

      • Travel

      • All Travel
      • Amusement Parks and Tourist Attractions
      • Gambling & Casinos
      • Hotels and Resorts
      • Leisure & Tourism
      • Outdoors, Camping & Hiking
      • Passenger Aviation
      • Travel Industry
      • Travel Overview

      • View All Travel

  • Policy & Public Interest
      • Policy & Public Interest

      • All Policy & Public Interest
      • Advocacy Group Opinion
      • Animal Welfare
      • Congressional & Presidential Campaigns
      • Corporate Social Responsibility
      • Domestic Policy
      • Economic News, Trends, Analysis
      • Education
      • Environmental
      • European Government
      • FDA Approval
      • Federal and State Legislation
      • Federal Executive Branch & Agency
      • Foreign Policy & International Affairs
      • Homeland Security
      • Labor & Union
      • Legal Issues
      • Natural Disasters
      • Not For Profit
      • Patent Law
      • Public Safety
      • Trade Policy
      • U.S. State Policy
      • Policy & Public Interest Overview

      • View All Policy & Public Interest

  • People & Culture
      • People & Culture

      • All People & Culture
      • Aboriginal, First Nations & Native American
      • African American
      • Asian American
      • Children
      • Diversity, Equity & Inclusion
      • Hispanic
      • Lesbian, Gay & Bisexual
      • Men's Interest
      • People with Disabilities
      • Religion
      • Senior Citizens
      • Veterans
      • Women
      • People & Culture Overview

      • View All People & Culture

      • In-Language News

      • Arabic
      • español
      • português
      • Česko
      • Danmark
      • Deutschland
      • España
      • France
      • Italia
      • Nederland
      • Norge
      • Polska
      • Portugal
      • Россия
      • Slovensko
      • Suomi
      • Sverige
  • Overview
  • Distribution by PR Newswire
  • Cision Communications Cloud®
  • Cision IR
  • Sponsored Placement
  • All Products
  • General Inquiries
  • Request a Demo
  • Editorial Bureaus
  • Partnerships
  • Media Inquiries
  • Worldwide Offices
  • PR Newswire: news distribution, targeting and monitoring
  • Send a Release
    • ALL CONTACT INFO
    • Contact Us

      888-776-0942
      from 8 AM - 10 PM ET

  • Send a Release
  • Sign Up
  • Log In
  • Resources
  • Blog
  • Journalists
  • RSS
  • GDPR
  • News in Focus
    • Browse All News
    • Multimedia Gallery
    • Trending Topics
  • Business & Money
    • Auto & Transportation
    • Business Technology
    • Entertain­ment & Media
    • Financial Services & Investing
    • General Business
  • Science & Tech
    • Consumer Technology
    • Energy & Natural Resources
    • Environ­ment
    • Heavy Industry & Manufacturing
    • Telecomm­unications
  • Lifestyle & Health
    • Consumer Products & Retail
    • Entertain­ment & Media
    • Health
    • Sports
    • Travel
  • Policy & Public Interest
  • People & Culture
    • People & Culture
  • Send a Release
  • Sign Up
  • Log In
  • Resources
  • Blog
  • Journalists
  • RSS
  • GDPR
  • Overview
  • Distribution by PR Newswire
  • Cision Communications Cloud®
  • Cision IR
  • All Products
  • Send a Release
  • Sign Up
  • Log In
  • Resources
  • Blog
  • Journalists
  • RSS
  • GDPR
  • General Inquiries
  • Request a Demo
  • Editorial Bureaus
  • Partnerships
  • Media Inquiries
  • Worldwide Offices
  • Send a Release
  • Sign Up
  • Log In
  • Resources
  • Blog
  • Journalists
  • RSS
  • GDPR

Pharma Two B Announces Positive Topline Results from its Pivotal Phase III Study of P2B001 in Early Parkinson's Disease
  • Israel - English

Study successfully met its primary and key secondary endpoints, demonstrating superior efficacy of P2B001 compared to its individual components

P2B001 showed comparable efficacy to a marketed extended release (ER) pramipexole with significantly less daytime sleepiness and a superior safety profile

Topline results support P2B001's potential as a first line treatment for people with early Parkinson's disease, with easy administration (once daily with no titration)

Company plans to file an NDA in 2022


News provided by

Pharma Two B Ltd.

Dec 15, 2021, 07:33 ET

Share this article

Share this article


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
-
The adjusted mean change from baseline to week 12 in Total-UPDRS score was -2.66 points for P2B001 versus pramipexole 0.6 mg (p=0.0018) and -3.30 points for P2B001 versus rasagiline 0.75 mg (p=0.0001)

P2B001 Met Key Secondary Endpoint
-
The adjusted mean change from baseline to week 12 in ESS score for P2B001 versus the marketed pramipexole ER was -2.66 points (p<0.0001)

Calibration of P2B001 and Pramipexole ER
-
The adjusted mean change in total UPDRS score from baseline to week 12 for P2B001 (-7.98 points) and the marketed pramipexole ER (-8.35 points) are comparable

P2B001 Showed a Favorable Side Effect Profile 
-
 P2B001 was generally well tolerated, with more than 98% of treatment-emergent adverse events (TEAEs) being mild or moderate in severity.  Early treatment termination rates were similar across treatment groups (between 7.1% - 9.1%).

Treatment-emergent adverse events (TEAE) reported in >5% of participants in any arm


Pramipexole ER

P2B001

Pramipexole (0.6 mg)

Rasagiline (0.75 mg)

Somnolence

31.1%

14.7%

18.2%

4.8%

Nausea

23.0%

18.7%

16.2%

6.8%

Fatigue

17.6%

15.3%

14.9%

1.4%

Orthostatic hypotension

12.2%

2.7%

3.4%

2.7%

Constipation

9.5%

4.0%

7.4%

6.1%

Dizziness

9.5%

10.7%

9.5%

12.9%

Insomnia

9.5%

8.7%

6.1%

2.7%

Hallucinations related

6.8%

2.7%

2%

1.4%

Headache

6.8%

6.0%

9.5%

6.1%

Decreased appetite

5.4%

2.0%

1.4%

1.4%

Memory impairment

5.4%

0

0

0.7%

Pain in extremity

5.4%

1.3%

6.8%

1.4%

Fall

1.4%

4.0%

5.4%

3.4%

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
The study was a 12-week, multinational, randomized, double-blind, double-dummy, active-controlled, parallel group study designed to determine the efficacy, safety, and tolerability of P2B001 compared to its individual components and to a calibration arm of pramipexole ER in people with early Parkinson's disease.  It was conducted at 70 centers in the US, Europe, and Canada.  A total of 544 participants were randomized to one of four treatment arms: P2B001, a once daily ER combination product (comprised of pramipexole 0.6 mg and rasagiline 0.75 mg); pramipexole ER capsule 0.6 mg once daily; rasagiline ER capsule 0.75 mg once daily; and the currently marketed product pramipexole ER capsules titrated to an optimal dose for each individual patient (1.5 to 4.5 mg). The primary endpoint was the change in total Unified Parkinson's Disease Rating Scale (UPDRS, defined as the sum of parts II and III) for P2B001 as compared to each of its individual components over 12 weeks.  Secondary endpoints included a comparison of P2B001 with the calibration arm (currently marketed pramipexole ER) with regard to changes in the Epworth Sleepiness Scale (ESS) score, as well as comparison of P2B001 to its individual components in the motor (Part III) and activities of daily living (Part II) components of the UPDRS score, PDQ-39 ADL subscore, and PDQ-39 total score.  For more information, refer to ClinicalTrials.gov Identifier: NCT03329508.

About Pharma Two B
Pharma Two B is a clinical-stage pharmaceutical company that is developing differentiated and value-added products, based on reformulation and combinations of previously approved orally-administered drugs for neurological indications. The company aims to improve efficacy, safety and delivery profiles and address unmet medical needs while minimizing timelines to FDA approval via the 505(b)(2) pathway. The company's lead product P2B001 is being investigated as a treatment for early-stage Parkinson's disease. 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.

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.

Reference:
1 Olanow, CW et al., A Randomized Trial of a Low-Dose Rasagiline and Pramipexole Combination (P2B001) in Early Parkinson's Disease. Mov Disord. 2017;32(5):783-789. doi: 10.1002/mds.26941.

Contact:
Irit Aish
Vice President, Commercial and Business Development
[email protected]

U.S. investor contact:
Bob Yedid
LifeSci Advisors LLC
646-597-6989
[email protected]

Media contact:
Tsipi Haitovsky
Global Media Liaison
+972-52-598-9892
[email protected]

SOURCE Pharma Two B Ltd.

Modal title

Contact Cision

  • Cision Distribution 888-776-0942
    from 8 AM - 9 PM ET

  • Chat with an Expert
  • General Inquiries
  • Request a Demo
  • Editorial Bureaus
  • Partnerships
  • Media Inquiries
  • Worldwide Offices

Products

  • Cision Communication Cloud®
  • For Marketers
  • For Public Relations
  • For IR & Compliance
  • For Agency
  • For Small Business
  • All Products

About

  • About PR Newswire
  • About Cision
  • Become a Publishing Partner
  • Become a Channel Partner
  • Careers
  • COVID-19 Resources
  • Accessibility Statement
  • Asia
  • Brazil
  • Canada
  • Czech
  • Denmark
  • Finland
  • France
  • Germany
  • India
  • Israel
  • Italy
  • Mexico
  • Middle East
  • Middle East - Arabic
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Russia
  • Slovakia
  • Spain
  • Sweden
  • United Kingdom

My Services

  • All New Releases
  • Online Member Center
  • ProfNet

Contact Cision

Products

About

My Services
  • All News Releases
  • Online Member Center
  • ProfNet
Cision Distribution Helpline
888-776-0942
  • Terms of Use
  • Privacy Policy
  • Information Security Policy
  • Site Map
  • RSS
  • Cookie Settings
Copyright © 2023 Cision US Inc.