For Immediate Release
Newark, NJ, September 9th, 2014 – Symbiomix Therapeutics, a late-stage, privately held, biopharmaceutical company with a focus on women’s health, today made its first corporate announcement. The company reported completion of enrollment in a Phase 2 clinical trial evaluating the company’s lead product, SYM-1219, as the first oral, single dose treatment for bacterial vaginosis (BV) in the US.
Symbiomix was founded in 2012 by a team of experienced industry professionals and entrepreneurs. Symbiomix is backed by three of the world’s leading healthcare venture capital firms: OrbiMed, Fidelity Biosciences and HBM Partners, and by financial services partner Square 1 Bank. The Company’s lead product is SYM-1219 (secnidazole), a next generation 5-nitroimidazole antibiotic. It is a New Chemical Entity (NCE) to the United States.
“Symbiomix presents an exciting opportunity,” commented Klaus Veitinger, Venture Partner with OrbiMed and CEO of Symbiomix. “We have confidence that the Symbiomix team can successfully bring SYM-1219 to the US market.”
BV is a 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 US women annually and is the most common gynecological infection in the US among women ages 15-44 [1, 2].
“SYM-1219 could provide significant benefits to patients and have a major impact in the US women’s health market,” commented President, CFO and Co-Founder Robert Jacks. “The first oral, single dose treatment for BV could meet important unmet needs in a disease that annually affects up to 30% of US women of child bearing age .”
Symbiomix is executing a rapid program to gain FDA approval for SYM-1219 and to bring the product to the US market. Symbiomix conducted a comprehensive non-clinical program and filed an IND in 2013, and completed a Phase 1 trial in early 2014. A single, oral dose of SYM-1219 is currently being tested as a complete course of therapy in a multi-center, prospective, randomized, double-blind, placebo-controlled, dose-ranging Phase 2 trial to evaluate its effectiveness and safety in 215 women diagnosed with BV. The study is being conducted at more than 20 clinical and academic centers across the US. Symbiomix expects to initiate Phase 3 trials of SYM-1219 in 2015.
SYM-1219 (secnidazole), a New Chemical Entity (NCE) to the United States, is a next generation, 5-nitroimidazole antibiotic.
If approved as the first oral, single dose therapy for BV, SYM-1219 could provide better adherence than currently prescribed treatments. Non-adherence to anti-infective therapy is a problem that increases with the length and complexity of the drug regimen . Adherence with the leading therapy for the treatment of BV has been shown to be only approximately 50% . Non-adherence to anti-infective therapy can lead to treatment failure and recurrent disease. These clinical consequences have significant cost implications, including increased out-of-pocket expenses, increased office visits and tests, additional treatment costs, and lost productivity .
About Bacterial Vaginosis (BV)
BV is an infectious disease 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 US women annually and is the most common gynecological infection in the US among women ages 15-44 [1, 2]. BV can have a significant negative impact on the daily functioning and quality of life of affected women.
The US Centers for Disease Control and Prevention (CDC) states 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;
- Increasing the risk of contracting sexually transmitted diseases, such as chlamydia and gonorrhea, which can sometimes cause pelvic inflammatory disease and lead to infertility .
BV disproportionately affects disadvantaged populations, including women of color, and may contribute to persistent disparities in women’s health outcomes [3, 6].
About Symbiomix Therapeutics, LLC
Symbiomix (sim-bye-OH-mix) is a late-stage, privately held biopharmaceutical company with a focus on women’s health. Symbiomix is based in New Jersey, with additional offices in Maryland and Connecticut. The Company is also investigating other indications for SYM-1219 and exploring additional novel products. Please visit www.symbiomix.com and follow the Company on LinkedIn for more information.
3. Allsworth JE, Peipert JF. Prevalence of bacterial vaginosis: 2001-2004 National Health and Nutrition Examination Survey data. Obstetrics and gynecology 2007;109:114-20.
4. Kardas, P., Bishai, W., (2006). “Compliance in anti-infective medicine.” Adv Stud Med 2006; 6(7C):S652:S658.
5. Bartley, J. B., et al. (2004). “Personal digital assistants used to document compliance of bacterial vaginosis treatment.” Sex Transm Dis 31(8): 488-491.
6. Fiscella, K. (1996). “Racial disparities in preterm births. The role of urogenital infections.” Public Health Rep 111(2): 104-113.
Paul Oestreicher, Ph.D.