- Solosec™ (secnidazole oral granules) met primary registration endpoint for bacterial vaginosis (BV).
- Data included in publication submitted to FDA as part of recently-accepted New Drug Application undergoing priority review.
- If approved, Solosec™ will be the first and only single-dose oral therapy for BV.
Newark, NJ, July 17, 2017 – Symbiomix Therapeutics today announced the publication of positive data from a pivotal clinical trial of single dose Solosec™ (secnidazole oral granules) for the treatment of bacterial vaginosis (BV).  Data from the randomized, double-blind, dose-ranging, placebo-controlled, multi-center study (SYM-1219-201) were published in the August issue of Obstetrics & Gynecology. Solosec™ is a potent, next-generation, investigational 5-nitroimidazole antibiotic with enhanced pharmacokinetic properties, and is the first and only single-dose oral therapy in development for BV. Solosec™ is under investigation and the safety or effectiveness of the product have not been established.
BV is the most prevalent gynecological infection in the U.S. among women ages 15 to 44, with more than four million women treated annually. [2,3,4] More than 50 percent of women treated for BV have a recurrence within 12 months.  The most commonly prescribed oral BV treatment regimen requires twice-a-day dosing for seven days. Adherence with the current leading therapy for the treatment of BV has been shown to be only approximately 50 percent. 
“Although there are several treatment regimens for BV, none provide the benefit of a single oral dose combined with good efficacy,” said Sharon L. Hillier, PhD, University of Pittsburgh and the Magee-Women’s Research Institute and lead author on the publication. “The data suggest that secnidazole may provide an exciting new option for women with BV.”
In the SYM-1219-201 study, women with BV were randomized to 1 or 2 g secnidazole or placebo, each administered as a single oral dose. The primary endpoint was clinical cure (normalization of discharge, amine odor and clue cells) 21–30 days after treatment. In the modified intent-to-treat (mITT) population of 188 women, clinical cure rates were 67.7% for 2 g secnidazole compared with 17.7% for placebo (p<.001). This study enrolled frequent BV sufferers (>4 episodes per year), which made up 33% of the patients in the mITT cohort. The 2 g dose of secnidazole provided the greatest efficacy and was well tolerated. 
“The results of this study provide a strong rationale for the expanded development of Solosec™ and its potential as an important advancement in the treatment of BV and potentially other women’s health infections,” said David L. Stern, Symbiomix CEO. “We’re encouraged by these findings as we continue to advance Solosec™ with U.S. regulatory authorities and work towards our goal of bringing innovative medicines to market for prevalent gynecologic infections that can have serious health consequences.”
The U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for Solosec™ (secnidazole oral granules) in March 2017. In accordance with the FDA’s priority six-month review designation, the agency has established a user-fee goal date under the Prescription Drug User Fee Act (PDUFA) of September 2017.
About Trial SYM-1219-201
SYM-1219-201 is a phase 2, randomized, double-blind, dose-ranging, placebo-controlled, multi-center study to evaluate Solosec™ for the treatment of BV. In the trial, women with BV who met all Amsel criteria (characteristic discharge; pH 4.7 or greater; 20% or greater clue cells; positive whiff test) were randomized one-to-one-to-one at 24 U.S. centers to 1 or 2 g secnidazole compared with placebo. The primary endpoint was clinical cure (normalization of discharge, amine odor, and clue cells) 21–30 days after treatment. Secondary endpoints included microbiologic cure, defined as a Nugent score of 0–3, and therapeutic cure, defined as meeting criteria for both clinical and microbiologic cure. The modified intent-to-treat was used for efficacy analyses and included all randomized patients who met the enrollment criteria. 
Between May and September 2014, 215 patients were enrolled. The modified intent-to-treat population included 188 women (median age 33 years; 32% with four or more bacterial vaginosis episodes in the previous year) with baseline Nugent scores 4 or greater. Clinical, microbiologic, and therapeutic cure rates were 67.7%, 40.3%, and 40.3% for 2 g secnidazole and 51.6%, 23.4%, and 21.9% for 1 g secnidazole compared with 17.7%, 6.5%, and 6.5% for placebo, respectively (p<.05 for secnidazole compared with placebo; all endpoints). 
Treatment-emergent adverse events were reported in 19% (14/72), 13% (9/71), and 10% (7/72) in the 2 g secnidazole, 1 g secnidazole, and placebo groups, respectively. Infections were the most common events in all treatment groups (6.3%), but were similar in incidence across the three treatment groups. Vaginal yeast infections were infrequent, occurring in seven women, five of whom received secnidazole. All treatment-emergent adverse events were mild or moderate in intensity. No serious adverse events were reported. 
About Bacterial Vaginosis (BV)
BV is the most prevalent gynecological infection in the U.S. among women ages 15 to 44. [2,3] Today more than four million women are treated in the U.S. for BV annually.  More than 50 percent of women treated for BV have a recurrence within 12 months.  The U.S. Centers for Disease Control and Prevention (CDC) has stated that BV can cause serious health risks, including:
- Increasing the risk of HIV transmission;
- Increasing the risk of contracting other sexually transmitted diseases, such as chlamydia and gonorrhea, which, if untreated, may lead to pelvic inflammatory disease and infertility; and
- In pregnant women, increasing the risk of delivering a baby too early. 
BV disproportionately affects disadvantaged populations, including women of color, and may contribute to persistent disparities in women’s health outcomes. [7,8]
BV has a significant impact on the work productivity and quality-of-life of affected women, with 60% of recurrent sufferers reporting a negative impact on work attendance, job performance and productivity, and 95% reporting a severe restriction in intimate partner relations. [9,10]
The current recommended regimen of a first-generation nitroimidazole requires twice-a-day dosing for seven days for a total administration of seven grams of drug. Adherence with the current leading therapy for the treatment of BV has been shown to be only approximately 50 percent.  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 Symbiomix Therapeutics, LLC
Symbiomix (sim-bye-OH-mix) is a biopharmaceutical company bringing innovative medicines to market for prevalent gynecological infections that can have serious health consequences. The Company’s lead investigational drug Solosec™ (secnidazole oral granules), 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 https://symbiomix.com/ and follow the Company on LinkedIn and Twitter for more information.
- Hillier, S.L., et al. (2017). “Secnidazole Treatment of Bacterial Vaginosis: A Randomized Controlled Trial.” Obstetrics & Gynecology 130(2): http://journals.lww.com/greenjournal/Abstract/publishahead/Secnidazole_Treatment_of_Bacterial_Vaginosis__A.98347.aspx.
- Allsworth, J.E., Peipert, J.F. (2007). “Prevalence of Bacterial Vaginosis: 2001-2004 National Health and Nutrition Examination Survey Data.” Obstetrics & Gynecology 109:114-20.
- IMS Health, 2014
- Bradshaw, C.S., 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. Jun 1;193(11):1478-86.
- Bartley, J.B., et al. (2004). “Personal Digital Assistants Used to Document Compliance of Bacterial Vaginosis Treatment.” Sex Transm Dis 31(8): 488-491.
- Fiscella, K. (1996). “Racial Disparities in Preterm Births. The Role of Urogenital Infections.” Public Health Rep 111(2): 104-113.
- Payne et al. (2010). “Evidence of African-American Women’s Frustrations with Chronic, Recurrent Bacterial Vaginosis.” Jn AANP 22:101-108.
- Bilardi et al. (2013). “The Burden of Bacterial Vaginosis: Women’s Experience of the Physical, Emotional, Sexual and Social Impact of Living with Recurrent Bacterial Vaginosis.” PlusOne vol 8, issue 9.
- 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 6(7C):S652-S658.