Symbiomix Therapeutics Announces Publication of Pivotal Phase 3 Data for Investigational Solosec™ for the Treatment of Bacterial Vaginosis

• Solosec™ (secnidazole) oral granules met all primary and secondary
  endpoints for bacterial vaginosis (BV)
• Second pivotal data set submitted to FDA as part of New Drug
  Application undergoing priority review to be published
• If approved, Solosec™ will be the first and only single-dose oral
  therapy for BV, the most common gynecological infection in the
  U.S.

NEWARK, N.J.–(BUSINESS WIRE)–Symbiomix Therapeutics today announced the publication of positive phase
3 data from a pivotal clinical trial of investigational single-dose
Solosec™ (secnidazole) oral granules for the treatment of bacterial
vaginosis (BV). [1] Data from the randomized, double-blind,
placebo-controlled, multi-center study (SYM-1219-301) were published
ahead of print in the online version of the American
Journal of Obstetrics & Gynecology. Solosec™ is a potent,
next-generation, 5-nitroimidazole antibiotic with enhanced
pharmacokinetic properties, and is the first and only single-dose oral
therapy in development for BV, the most common gynecological infection
in the U.S. [2]

BV is the most common vaginal infection in the U.S. among women ages
14-49 years old, with more than four million treated annually. One in
three women have BV, affecting more than 21 million in the U.S. each
year. More than 50 percent of women treated for BV have a recurrence
within 12 months. [2,3,4,5,6]

“The current recommended treatment options mainly consist of multi-dose
therapy, which can lead to issues with medication adherence,” said Jane
R. Schwebke, MD, Professor of Medicine and Infectious Diseases at the
University of Alabama at Birmingham and lead author of the publication.
“The data supports secnidazole as an effective and well-tolerated
potential single-dose option for BV that will be a welcome advance in
the treatment of this prevalent gynecologic infection.”

In the SYM-1219-301 study, women with BV were randomized to 2 g
secnidazole or placebo, each administered as a single oral dose. The 2 g
dose of secnidazole proved superior to placebo on all primary and
secondary outcomes and was well tolerated.

In the modified intent-to-treat (mITT) population of 189 women, clinical
outcome responder rates were 53.3% for 2 g secnidazole compared with
19.3% for placebo (p<0.001). The clinical outcome responder rate
analysis was 58.9% for 2 g secnidazole compared with 24.6% for placebo
(p<0.001) when women with abnormal discharge that is inconsistent with
BV were included as clinical outcome responders. Clinical cure rates
based on the 2016 FDA guidance of 7-14 days after treatment were 64.0%
for 2 g secnidazole compared with 26.4% for placebo. Based on the
investigator’s clinical assessment at the test of cure, significantly
more patients receiving single-dose secnidazole 2 g compared to placebo
required no additional BV treatment (68.0% vs 29.6%; P<0.001). The
overall adverse event rate was 34.4% for single-dose secnidazole 2 g
compared to 21.9% for placebo. Most adverse events were mild or moderate
in intensity and non-serious. [1]

“The study results support the potential of Solosec™ as a new treatment
option for the millions of women in the U.S. suffering with bacterial
vaginosis,” said David L. Stern, Symbiomix CEO. “These findings
encourage our efforts to expand the development of Solosec™ and we are
continuing to work with U.S. regulatory authorities to bring innovative
therapies 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-1219-301

SYM-1219-301 is a phase 3, 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 2:1 at 21 U.S. centers to 1 or 2 g
secnidazole compared with placebo. The primary endpoint was the
proportion of clinical outcome responders (normalization of discharge,
amine odor and clue cells) 21–30 days after treatment. Secondary
endpoints included clinical cure rates (normalization of discharge,
amine odor and clue cells) assessed 7–14 days after treatment and test
of cure 21–30 days after treatment. Based on the 2016 FDA draft
guidance, patients with baseline Nugent scores 7–10 were evaluated for
clinical cure (normalization of discharge, amine odor and clue cells)
7–14 days after treatment. The modified intent-to-treat was used for
efficacy analyses and included all randomized patients who met the
enrollment criteria. [1]

Between May 4, 2015 and August 26, 2015, 125 and 64 patients were
assigned 2:1 to single-dose secnidazole 2 g and placebo, respectively.
The modified intent-to-treat population included 189 women (mean age was
32 years; 77.2% with 3 or less BV episodes in the previous 12 years)
with the mean baseline Nugent score of 8. Clinical cure rates were
58.9%, 53.3%, and 64.0% for 2 g secnidazole compared with 24.6%, 19.3%,
and 36.4% for placebo. [1]

Treatment-emergent adverse events were reported in 20.0% of single-dose
secnidazole 2 g–treated patients and 10.9% of placebo patients. Severe
adverse events among single-dose secnidazole 2 g–treated patients
included diarrhea and syncope (2 patients each) and dehydration, ectopic
pregnancy, and vulvovaginal mycotic infection (1 patient each); of these
events, both cases of diarrhea and the vulvovaginal mycotic infection
were assessed as treatment-related. Two severe events, ectopic pregnancy
and 1 case of syncope, also were serious; both events were assessed as
unrelated to study drug. [1]

About Bacterial Vaginosis (BV)

BV is the most prevalent gynecological infection in the U.S. among women
ages 14-49. [2,3] Today more than four million women are treated in the
U.S. for BV annually. [4] More than 50 percent of women treated for BV
have a recurrence within 12 months. [6] 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.
  [4]

BV disproportionately affects disadvantaged populations, including women
of color, and may contribute to persistent disparities in women’s health
outcomes. [8,9]

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. [10,11]

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. [7]
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. [1,2] 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. [1,3]

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.

Contacts

Media:
Symbiomix Therapeutics
Alana Rockland
O:
646.503.2732
M: 301.537.5392
arockland@w2ogroup.com