Symbiomix Therapeutics Doses First Patient in Confirmatory Phase 3 Pivotal Study of Lead Drug Candidate SYM-1219 for Bacterial Vaginosis

NEWARK, N.J., June 9, 2015 /PRNewswire/ -- Symbiomix Therapeutics today announced the dosing of the first patient in a Phase 3 clinical trial, the second of two planned pivotal trials for its lead drug candidate SYM-1219 for the treatment of bacterial vaginosis (BV). Symbiomix previously announced that it plans to submit the multi-center, randomized Phase 2 trial completed last year as one of two pivotal trials required for a New Drug Application (NDA) filing. This Phase 3 trial is the second pivotal study to support an NDA submission for BV. SYM-1219 is a novel drug candidate that contains secnidazole, an antibiotic with favorable pharmacokinetics (PK) allowing for single-dose oral therapy in a condition that is marked by high recurrence rates and low adherence to the current recommended treatment.

"With the start of this Phase 3 clinical trial we remain on track for an anticipated NDA filing of SYM-1219 for the treatment of BV in the U.S. in mid-2016," said Robert Jacks, President and CFO of Symbiomix. "We anticipate rapid patient enrollment into this trial with plans to complete the study by the end of 2015."

The Phase 3 study is a multi-center, prospective, randomized, double-blind, placebo-controlled trial with a very similar design to the previous pivotal Phase 2 trial. The Company expects to enroll at least 180 women diagnosed with BV to compare a single oral dose of SYM-1219 as a complete course of therapy to placebo. The study will be conducted at more than 20 sites across the U.S. The primary endpoint is Clinical Response at 21 to 30 days post treatment, which is the same endpoint used for the successful Phase 2 trial completed last year.

"The initiation of this trial moves us one step closer to bringing SYM-1219 to health care providers to help the millions of women suffering with BV in the U.S.," said Symbiomix Chief Medical Officer Carol Braun, M.D. "Due to its single-dose oral regimen, we believe SYM-1219 can lead to better adherence to therapy, which may lead to improved treatment outcomes in this serious disease."

For more information about SYM-1219 clinical trials, patients and healthcare providers may contact Symbiomix or go to www.clinicaltrials.gov and use the search term Symbiomix or the identifiers "BV," "bacterial vaginosis" or "SYM-1219."

About SYM-1219

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 bacterial vaginosis (BV). A multi-center, randomized Phase 2 trial testing a single oral dose of SYM-1219 for the treatment of BV recently demonstrated clinically meaningful and highly statistically significant results for both its primary and secondary endpoints.

A confirmatory Phase 3 trial is currently enrolling patients at more than 20 clinical centers across the U.S. Symbiomix is targeting an NDA filing for SYM-1219 for the treatment of BV in mid-2016. 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 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 [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].

SYM-1219 has been designated a Qualified Infectious Disease Product (QIDP) by the U.S. Food and Drug Administration (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. 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 NCE market exclusivity.

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 [4].

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 [1].  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.

REFERENCES

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.       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.

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

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

SOURCE Symbiomix Therapeutics

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