Symbiomix Therapeutics Studies Show Drug Candidate for Women's Health Infections is Safe and Well-Tolerated

NEWARK, N.J., March 4, 2015 /PRNewswire/ -- Symbiomix Therapeutics, a late-stage, privately held biopharmaceutical company developing innovative medicines for serious women's health infections, today announced results from its Phase 1 clinical program demonstrating that its lead product candidate, SYM-1219, was safe and well tolerated and had predictable pharmacokinetics (PK), and that contraceptive efficacy for birth control pills would not be altered by SYM-1219 administration.

These results will be presented on March 6^th at the annual meeting of the American Society of Clinical Pharmacology and Therapeutics (ASCPT), which takes place in New Orleans from today through March 7^th. Following are the details for the two posters presenting the study results:

• Poster (#42) is entitled, "A Phase 1 Study to Determine the Single Dose Safety and Pharmacokinetics of SYM-1219 (Secnidazole) in Healthy Female Volunteers."
• Poster (#92) is entitled, "A Phase 1, Open-label Study to Determine the Effect of SYM-1219 on the Pharmacokinetics of Ethinyl Estradiol (EE2) and Norethindrone (NET) in Healthy Female Volunteers."

Data from 28 healthy women demonstrated that single, oral, 1- and 2-gram doses of SYM-1219 were safe and well tolerated. The drug has a long half-life and there was consistent PK with low variability between the study subjects.

In addition, data were collected from 54 healthy women who took a single oral dose of SYM-1219 combined with a single dose of an ethinyl estradiol/norethindrone combination birth control pill. The data show that the contraceptive efficacy of birth control pills would not be altered by single-dose SYM-1219 administration.

"These data support the advancement of SYM-1219 into later-stage clinical trials to evaluate a single oral dose as a treatment for bacterial vaginosis (BV) and other women's health infections," said Helen S. Pentikis, Ph.D., Chief Scientific Officer of Symbiomix and first author on these abstracts. "Left untreated, BV can cause serious health risks to women. We believe that SYM-1219, as a single-dose oral regimen, will achieve significantly better adherence to treatment than current leading therapies, leading to better health outcomes."

Symbiomix is executing a rapid drug development program to gain U.S. Food & Drug Administration (FDA) approval for SYM-1219. The company recently completed a Phase 2 clinical trial in women with BV, and is targeting a New Drug Application (NDA) filing in mid-2016. If approved by the FDA, SYM-1219 would be the first single-dose, oral therapy for the treatment of BV, which currently impacts more than 20 million women in the United States each year.

About SYM-1219
SYM-1219 is a novel drug candidate that contains secnidazole, a New Chemical Entity (NCE) in the United States. Secnidazole is a next generation, 5-nitroimidazole antibiotic with favorable PK that facilities administration as a single-dose therapy. Symbiomix is executing a rapid clinical development program to bring SYM-1219 to the U.S. market for several serious women's health infections, including bacterial vaginosis (BV). Symbiomix is targeting an NDA filing for SYM-1219 for the treatment of BV in mid-2016, towards commercial launch in early 2017. SYM-1219 would be the first single-dose oral therapy approved to treat BV in the United States. Because of its single-dose oral regimen, Symbiomix believes that SYM-1219 will achieve significantly better adherence to treatment than current leading agents, 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 [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].

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 [4]. 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 [1].

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

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 product is SYM-1219, a novel drug candidate containing secnidazole, which is a next generation 5-nitroimidazole antibiotic and a New Chemical Entity (NCE) to the United States. Symbiomix is based in New Jersey, with additional offices in Maryland and Connecticut. Please visit www.symbiomix.com and follow the Company on LinkedIn for more information.

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

6.       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.

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

SOURCE Symbiomix Therapeutics, LLC

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