Accessibility Statement Skip Navigation
  • Resources
  • Investor Relations
  • Journalists
  • Agencies
  • Client Login
  • Send a Release
Return to PR Newswire homepage
  • 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
  • Explore Our Platform
  • Plan Campaigns
  • Create with AI
  • Distribute Press Releases
  • Amplify Content
  • All Products
  • General Inquiries
  • Editorial Bureaus
  • Partnerships
  • Media Inquiries
  • Worldwide Offices
  • Hamburger menu
  • 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
  • Client Login
  • Resources
  • Blog
  • Journalists
  • RSS
  • 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
  • Client Login
  • Resources
  • Blog
  • Journalists
  • RSS
  • Explore Our Platform
  • Plan Campaigns
  • Create with AI
  • Distribute Press Releases
  • Amplify Content
  • All Products
  • Send a Release
  • Client Login
  • Resources
  • Blog
  • Journalists
  • RSS
  • General Inquiries
  • Editorial Bureaus
  • Partnerships
  • Media Inquiries
  • Worldwide Offices
  • Send a Release
  • Client Login
  • Resources
  • Blog
  • Journalists
  • RSS

Symbiomix Therapeutics Announces Positive Results from Phase 3 Trial of SYM-1219 for Bacterial Vaginosis, and Pre-NDA Meeting with FDA Supportive of 2016 NDA Filing

-- With completion of second successful pivotal trial, company targeting Q4 2016 for NDA filing for SYM-1219 for the treatment of BV


News provided by

Symbiomix Therapeutics, LLC

May 26, 2016, 08:30 ET

Share this article

Share toX

Share this article

Share toX

NEWARK, N.J., May 26, 2016 /PRNewswire/ -- Symbiomix today announced positive results from the second pivotal trial of lead product candidate SYM-1219 (secnidazole) for the treatment of bacterial vaginosis (BV). SYM-1219 is a potent, next-generation 5-nitroimidazole antibiotic anticipated to be the first and only single-dose oral treatment approved for BV. The company also announced a successful pre-NDA meeting with the U.S. Food & Drug Administration (FDA) to discuss the requirements for a New Drug Application (NDA) filing for SYM-1219. These milestones keep the product on track for a planned NDA filing in the fourth quarter of 2016. SYM-1219 has been designated a Qualified Infectious Disease Product (QIDP) by the FDA, which makes the product eligible for priority review and at least 10 years of market exclusivity.

The second pivotal trial of SYM-1219 for the treatment of BV was a Phase 3, randomized, double-blind, placebo-controlled trial in 189 women comparing a single, oral dose of SYM-1219 to a placebo in both infrequent sufferers and patients with recurrent BV. SYM-1219 achieved statistically and clinically significant results across all primary and secondary endpoints. These results were consistent with data from the first pivotal trial, which were presented at the 2015 Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) Annual Meeting. The complete data from this Phase 3 study will be presented at an upcoming medical meeting.

"SYM-1219 is a true innovation for this common gynecological infection that can have serious health consequences," commented Symbiomix Head of R&D and Chief Medical Officer Tom Beck, M.D. "We believe that this single-dose oral treatment will be the best option for women suffering with BV."

Symbiomix also announced a successful pre-NDA meeting with the FDA. The company has now reached agreement with the agency on all requirements for an NDA filing.

"These milestones support our plan to file the SYM-1219 NDA in the fourth quarter of 2016," said Robert Jacks, Symbiomix President and CFO. "We remain focused on commercial launch in 2017."

About SYM-1219

SYM-1219 (secnidazole) is a potent, next-generation 5-nitroimidazole antibiotic with superior pharmacokinetic properties that enable efficacy with significantly less total drug exposure than first generation nitroimidazoles, leading to excellent safety, tolerability and adherence. Symbiomix has completed clinical development of SYM-1219 as a single-dose oral therapy for the treatment of BV and is on target for NDA filing in the fourth quarter of 2016 toward commercial launch in the second half of 2017.

SYM-1219 oral granules are anticipated to be the first and only single-dose oral therapy approved for BV. Because of its single-dose oral regimen, Symbiomix believes SYM-1219 will offer leading effectiveness and achieve better adherence to treatment than the current standard of care, leading to better patient outcomes. Adherence with the current leading therapy for the treatment of BV has been shown to be only approximately 50 percent 1. Further, poor adherence to anti-infective therapy is a problem that increases with the length and complexity of the drug regimen, and can lead to treatment failures, recurrent disease and the more rapid development of resistant microorganisms 2. These, in turn, may lead to higher health care costs, including increased out-of-pocket expenses, increased office visits and tests, additional treatment costs, and lost productivity 3.

SYM-1219 has been designated a Qualified Infectious Disease Product (QIDP) by the U.S. Food and Drug Administration (FDA) for the treatment of BV. QIDP designation creates incentives for the development of new drugs intended to treat serious or life threatening infections. QIDP designation makes SYM-1219 eligible for certain benefits, including priority review, fast-track designation, and at least 10 years of market exclusivity.

About Bacterial Vaginosis (BV)

BV is the most common gynecological infection in the U.S. among women ages 15 to 44 5. Today more than four million women are treated in the US for BV annually 8.

The U.S. Centers for Disease Control and Prevention (CDC) has stated that BV can cause serious health risks, including the following:

  • Increasing the risk of HIV transmission from an HIV infected partner;
  • Increasing the risk of HIV transmission to an HIV-uninfected partner;
  • In pregnant women, increasing the risk of delivering a baby too early; and,
  • Increasing the risk of contracting sexually transmitted diseases, such as chlamydia and gonorrhea, which, if untreated, may lead to pelvic inflammatory disease and infertility 4.

BV disproportionately affects disadvantaged populations, including women of color, and may contribute to persistent disparities in women's health outcomes 4,6,7.

Adherence with the current leading therapy for the treatment of BV has been shown to be only approximately 50 percent 1.  More than 50 percent of women treated for BV have a recurrence within 12 months 9.

About Symbiomix Therapeutics, LLC

Symbiomix (sim-bye-OH-mix) is a biopharmaceutical company bringing innovative medicines to market for common gynecological infections than can have serious health consequences. The Company's lead drug candidate SYM-1219 (secnidazole), a potent, next-generation 5-nitroimidazole antibiotic, is anticipated to be the first and only single-dose oral treatment approved for bacterial vaginosis (BV).  Symbiomix was founded in 2012 by a team of experienced industry professionals and entrepreneurs and is backed by three of the world's leading healthcare venture capital firms: OrbiMed, F-Prime Capital Partners, and HBM Partners. Symbiomix is based in New Jersey, with additional offices in Maryland and Connecticut. Please visit www.symbiomix.com and follow the Company on LinkedIn and Twitter for more information.

REFERENCES

1. Bartley, J.B., et al. (2004). "Personal digital assistants used to document compliance of bacterial vaginosis treatment." Sex Transm Dis 31(8): 488-491.

2. Kardas, P. (2002). "Once-Daily Dosage Secures Better Compliance With Antibiotic Therapy of Respiratory Tract Infections Than Twice-Daily Dosage." WONCA Europe 2002 Conference, London.

3. Kardas, P., Bishai, W., (2006). "Compliance in anti-infective medicine." Adv Stud Med 2006; 6(7C):S652:S658.

4. http://www.cdc.gov/std/bv/stdfact-bacterial-vaginosis.htm

5. Allsworth J.E., Peipert, J.F. Prevalence of bacterial vaginosis: 2001-2004 National Health and Nutrition Examination Survey data.  Obstetrics and gynecology 2007;109:114-20.

6. http://www.cdc.gov/std/bv/stats.htm

7. Fiscella, K. (1996). "Racial disparities in preterm births. The role of urogenital infections." Public Health Rep 111(2): 104-113.

8. IMS Health, 2014

9. Bradshaw CS, et al. (2006). "High recurrence rates of bacterial vaginosis over the course of 12 months after oral metronidazole therapy and factors associated with recurrence" J Infect Dis. 2006 Jun 1;193(11):1478-86.

SOURCE Symbiomix Therapeutics, LLC

Related Links

http://www.symbiomix.com

WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM?

icon3
440k+
Newsrooms &
Influencers
icon1
9k+
Digital Media
Outlets
icon2
270k+
Journalists
Opted In
GET STARTED

Modal title

Contact PR Newswire

  • Call PR Newswire at 888-776-0942
    from 8 AM - 9 PM ET
  • Chat with an Expert
  • General Inquiries
  • Editorial Bureaus
  • Partnerships
  • Media Inquiries
  • Worldwide Offices

Products

  • For Marketers
  • For Public Relations
  • For IR & Compliance
  • For Agency
  • All Products

About

  • About PR Newswire
  • About Cision
  • Become a Publishing Partner
  • Become a Channel Partner
  • Careers
  • Accessibility Statement
  • APAC
  • APAC - Simplified Chinese
  • APAC - Traditional Chinese
  • Brazil
  • Canada
  • Czech
  • Denmark
  • Finland
  • France
  • Germany
  • India
  • Indonesia
  • Israel
  • Italy
  • Japan
  • Korea
  • Mexico
  • Middle East
  • Middle East - Arabic
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Russia
  • Slovakia
  • Spain
  • Sweden
  • United Kingdom
  • Vietnam

My Services

  • All New Releases
  • Platform Login
  • ProfNet
  • Data Privacy

Do not sell or share my personal information:

  • Submit via [email protected] 
  • Call Privacy toll-free: 877-297-8921

Contact PR Newswire

Products

About

My Services
  • All News Releases
  • Platform Login
  • ProfNet
Call PR Newswire at
888-776-0942
  • Terms of Use
  • Privacy Policy
  • Information Security Policy
  • Site Map
  • RSS
  • Cookies
Copyright © 2025 Cision US Inc.