Symbiomix Therapeutics Announces FDA's Acceptance of New Drug Application for Solosec™ with Priority Review Status

NEWARK, N.J., March 23, 2017 /PRNewswire/ -- Symbiomix today announced that the US Food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for its lead investigational product candidate Solosec™ (secnidazole oral granules), an innovative antibiotic designed to treat bacterial vaginosis (BV). In accordance with the FDA's priority 6-month review designation, the agency has established a user-fee goal date under the Prescription Drug User Fee Act (PDUFA) of September 17, 2017. Symbiomix submitted the NDA filing in January 2017.

Solosec™ is a potent, next-generation, investigational 5-nitroimidazole antibiotic with enhanced pharmacokinetic properties, which will be the first and only single-dose oral therapy approved for BV if approved by the FDA. The FDA previously designated Solosec™ as a Qualified Infectious Disease Product (QIDP) for the treatment of BV and granted it Fast Track designation, which made Solosec™ eligible for priority review and at least 10 years of market exclusivity.

"The FDA's acceptance of the NDA with priority review for Solosec™ is a critical milestone for Symbiomix," said David L. Stern, Symbiomix CEO. "As a single-dose oral treatment, Solosec™ could improve adherence, potentially leading to better health outcomes for the millions of women suffering with BV. Solosec™ represents an important potential advancement in the treatment of women's health infections."

The Solosec™ NDA was supported by a comprehensive set of non-clinical and clinical studies conducted and reported by Symbiomix, including the two pivotal trials in BV (SYM-1219-201 and SYM-1219-301), results from which were presented at the Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) Annual Meetings in 2015 and 2016, respectively.

About Solosec™
Solosec™ is a potent, next-generation, investigational 5-nitroimidazole antibiotic with enhanced pharmacokinetic properties. In clinical trials Solosec™ demonstrated efficacy for the treatment of BV with only a single, oral, two-gram dose, with excellent safety, tolerability and adherence.

About Bacterial Vaginosis (BV)
BV is the most prevalent gynecological infection in the U.S. among women ages 15 to 44 [1,2]. Today more than four million women are treated in the US for BV annually [3]. More than 50 percent of women treated for BV have a recurrence within 12 months [4]. 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 [2].

BV disproportionately affects disadvantaged populations, including women of color, and may contribute to persistent disparities in women's health outcomes [5,6].

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 [7,8].

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 [9]. 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 [10]. 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 [11].

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 www.symbiomix.com and follow the Company on LinkedIn and Twitter for more information.

REFERENCES

1. 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.
2. http://www.cdc.gov/std/bv/stdfact-bacterial-vaginosis.htm
3. IMS Health, 2014
4. Bradshaw CS, 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. 2006 Jun 1;193(11):1478-86.
5. http://www.cdc.gov/std/bv/stats.htm
6. Fiscella, K. (1996). "Racial disparities in preterm births. The role of urogenital infections." Public Health Rep 111(2): 104-113.
7. Payne et al. (2010). "Evidence of African-American women's frustrations with chronic, recurrent bacterial vaginosis." Jn AANP 22(2010) 101-108.
8. 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 Sept 2013, vol 8, issue 9.
9. Bartley, J.B., et al. (2004). "Personal digital assistants used to document compliance of bacterial vaginosis treatment." Sex Transm Dis 31(8): 488-491.
10. 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.
11. Kardas, P., Bishai, W., (2006). "Compliance in anti-infective medicine." Adv Stud Med 2006; 6(7C):S652:S658.

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