NEWARK, N.J., Aug. 6, 2015 /PRNewswire/ -- Positive results of Symbiomix Therapeutics' first pivotal trial for lead drug candidate SYM-1219, a single-dose, oral product candidate for the treatment of bacterial vaginosis (BV), were presented today at the Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) Annual Meeting in Portland, Oregon. The results from the multi-center, randomized Phase 2 trial showed that a single oral dose of SYM-1219 met the trial's primary endpoint of Clinical Outcome Responder and was well tolerated for the treatment of BV. Based on discussions with the U.S. Food and Drug Administration (FDA) at an End-of-Phase 2 meeting, the Company plans to submit the Phase 2 trial as one of two pivotal studies for a New Drug Application (NDA). A second pivotal trial of SYM-1219 is currently enrolling patients, with targeted completion by the end of 2015. If the second pivotal trial is successful, an NDA could be submitted in mid-2016.
SYM-1219 is a novel drug candidate that contains secnidazole, an antibiotic with favorable pharmacokinetics (PK) allowing for single-dose oral therapy to treat BV, a condition that is marked by high recurrence rates and low adherence to the current recommended treatments. The pivotal study data presented today were from a multi-center, prospective, randomized, double-blind, placebo-controlled study in 215 women conducted at 24 clinical sites across the U.S. that compared two different doses of SYM-1219 to placebo for the treatment of BV. The results for the primary endpoint showed that a single oral dose of SYM-1219 containing 2g of secnidazole achieved a 67.7 percent Clinical Outcome Responder rate at 21 to 30 days post treatment in the modified intent to treat (mITT) population, versus 17.7 percent for placebo, a statistically significant (p<0.001) and clinically meaningful result. A Clinical Outcome Responder was defined as a patient with all of the following: normal vaginal discharge, negative 10 percent KOH Whiff test; and clue cells less than 20 percent of the total epithelial cells on microscopic examination. SYM-1219 was also very well tolerated in the study patients. The abstract of this presentation will be published in the December issue of the American Journal of Obstetrics & Gynecology.
Symbiomix Chief Medical Officer Carol Braun, M.D. commented, "Importantly, SYM-1219 achieved these clinical results with a single oral dose. These data suggest that treatment with SYM-1219 may lead to improved treatment outcomes for women with this serious disease."
The company is currently enrolling patients into a second pivotal trial of SYM-1219 for the treatment of BV. The second pivotal trial has a very similar design to the first pivotal trial, including the same primary endpoint.
"The excellent results from this pivotal Phase 2 study allow us to begin to think ahead to the commercialization of SYM-1219, as we are targeting a 2017 launch," said Robert Jacks, President and CFO of Symbiomix.
SYM-1219 has been designated a Qualified Infectious Disease Product (QIDP) by the FDA for the treatment of BV. QIDP designation makes SYM-1219 eligible for certain benefits, including priority review and fast-track designation. Further, if ultimately approved by the FDA, SYM-1219 would be eligible for a five-year extension of exclusivity as an addition to new chemical entity (NCE) market exclusivity.
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 .
SYM-1219 has been designated a Qualified Infectious Disease Product (QIDP) by the FDA for the treatment of BV. QIDP designation was created by the GAIN Act in 2012 to create incentives for the development of new drugs intended to treat serious or life threatening infections.
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 . 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, LLC