NEWARK, N.J., Aug. 27, 2015 /PRNewswire/ -- Symbiomix today announced the completion of patient enrollment in a Phase 3 clinical study, the second pivotal trial of SYM-1219, which is a single-dose, oral product candidate for the treatment of bacterial vaginosis (BV). Earlier this year Symbiomix announced positive results from the first pivotal trial for SYM-1219. Symbiomix expects to finish this second pivotal trial by the end of 2015, which would enable a New Drug Application (NDA) filing with the U.S. Food and Drug Administration (FDA) in mid-2016.
Symbiomix also announced that the FDA has granted Fast Track designation to SYM-1219. The FDA's Fast Track program is designed to facilitate the development and expedite the review of drugs that are intended to treat serious conditions. Earlier this year Symbiomix announced that the FDA had designated SYM-1219 as a Qualified Infectious Disease Product (QIDP) for the treatment of BV. QIDP designation makes SYM-1219 eligible for certain benefits, including priority review. Further, if ultimately approved by the FDA, SYM-1219 would be eligible for a five-year extension of exclusivity in addition to new chemical entity (NCE) market exclusivity.
"The Symbiomix team has executed an aggressive timeline to drive SYM-1219 towards the market," said Robert Jacks, President and CFO. "Completing patient enrollment in this Phase 3 trial in less than four months, and achieving FDA Fast Track designation, are important milestones against our goal of filing an NDA by the middle of next year."
The Phase 3 study is a multi-center, prospective, randomized, double-blind, placebo-controlled trial. The Company enrolled 189 women diagnosed with BV to compare a single oral dose of SYM-1219 as a complete course of therapy to placebo. The study is being conducted at 22 sites across the U.S. The primary endpoint is Clinical Response at 21 to 30 days post treatment, which is the same primary endpoint used for the first pivotal trial.
Symbiomix Chief Medical Officer Carol Braun, M.D., said, "The ability to safely and effectively treat BV with a single oral dose of SYM-1219 would be an important clinical breakthrough for the millions of women in the United States suffering from this serious women's health infection."
SYM-1219 is a novel drug candidate containing secnidazole, which is a next-generation, 5-nitroimidazole antibiotic with favorable pharmacokinetics that facilitate administration as a single-dose oral therapy. Symbiomix is executing a rapid clinical development program with the goal of bringing the drug to the U.S. market for several serious women's health infections, including BV.
Because of its single-dose oral regimen, Symbiomix believes SYM-1219 will achieve better adherence to treatment than the current standard of care, leading to better health outcomes. Adherence with the current leading therapy for the treatment of BV has been shown to be only approximately 50 percent . 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 . 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 .
About Bacterial Vaginosis (BV)
BV is a highly prevalent gynecological infection that increases the risk of serious health problems such as HIV transmission and pre-term birth , and is marked by high recurrence rates and low adherence to the current recommended treatments. The disease is characterized by a disruption of the healthy microbiome of the vagina and an overgrowth of anaerobic Gram-negative bacteria. BV affects more than 20 million U.S. women annually and is the most common gynecological infection in the U.S. among women ages 15 to 44 [4,5].
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 .
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 . Currently, approximately 50 percent of women treated for BV will experience a recurrence within 12 months.
About Symbiomix Therapeutics, LLC
Symbiomix (sim-bye-OH-mix) is a late-stage, privately held biopharmaceutical company developing innovative medicines for serious women's health infections that have been long neglected and are in need of new therapeutic options. 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, Fidelity Biosciences and HBM Partners. The Company's lead drug candidate is SYM-1219, a novel product containing secnidazole, which is a next-generation 5-nitroimidazole antibiotic. 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.
- Bartley, J.B., et al. (2004). "Personal digital assistants used to document compliance of bacterial vaginosis treatment." Sex Transm Dis 31(8): 488-491.
- 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.
- Kardas, P., Bishai, W., (2006). "Compliance in anti-infective medicine." Adv Stud Med 2006; 6(7C):S652:S658.
- 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.
- Fiscella, K. (1996). "Racial disparities in preterm births. The role of urogenital infections." Public Health Rep 111(2): 104-113.
SOURCE Symbiomix Therapeutics