Osel, Inc.’s Lead Product LACTIN-V Enters Phase 2b Study to Prevent Recurrence of Bacterial Vaginosis

— Company focused on microbiome-restoring therapies and preventions
for women’s health —

MOUNTAIN VIEW, Calif.–(BUSINESS WIRE)–Osel, Inc. today announced the initiation of a Phase 2b clinical study
of its lead product candidate, LACTIN-V,
to prevent the recurrence of bacterial vaginosis following antibiotic
therapy. LACTIN-V is a live biotherapeutic product that contains a
naturally occurring Lactobacillus strain that is part of the
vaginal microbiome of healthy women and used to restore the vaginal
microbiota and prevent recurrence of infection.

The double-blind, placebo-controlled study, being conducted at four
centers throughout the United States, will enroll over 200 women to
estimate the efficacy of LACTIN-V compared to placebo in preventing
recurrence of bacterial vaginosis. A secondary endpoint of the study
will be to investigate the colonization of the beneficial bacteria
during the period of dosing. Osel expects completion of the Phase 2b
study in early 2018. The study is sponsored by the National Institute of
Allergy and Infectious Diseases in collaboration with the University of
California, San Francisco (UCSF) and other clinical sites.

“Currently the only FDA-approved treatments for bacterial vaginosis are
antibiotics. Antibiotics affect not only pathogenic bacteria but also
the beneficial bacteria in the microbiome, often leading to further
imbalance and dysbiosis,” said K.T. Moortgat, PhD, Chief Executive
Officer, Interim, of Osel, Inc. “We are eager to move LACTIN-V forward
in the clinic for evaluation as a restorative to the vaginal microbiome
following antibiotic treatment.”

Bacterial vaginosis (BV) is the most common vaginal infection in women
ages 15-44, according to the Centers for Disease Control and Prevention,
with a prevalence of over 29%. While infected women often report no
symptoms, they are at markedly higher risk for other sexually
transmitted disease and when pregnant, have higher rates of pre-term
birth. The approach to treating bacterial vaginosis has not changed in
several decades, and recurrence rates are high even following successful
treatment.

“Up until now, patients have lacked optimal treatment to prevent
recurrence of bacterial vaginosis,” said Craig Cohen, MD, MPH, Professor
of Obstetrics, Gynecology and Reproductive Sciences at UCSF and clinical
lead for the trial. “My team and I are excited that LACTIN-V will be
further evaluated in this Phase 2b study for its ability to address this
important clinical need. If LACTIN-V is proven efficacious, clinicians
will finally have an improved therapy to prevent BV by promoting a
natural Lactobacillus-dominant vaginal microbiome.”

LACTIN-V is the most advanced product candidate in Osel’s portfolio of
microbiome-modulating products. It incorporates a single strain of Lactobacillus
crispatus and is delivered intravaginally via a proprietary
applicator. LACTIN-V is designed to restore the healthy vaginal
microbiota to combat pathogenic bacteria and the dysbiosis that are seen
in bacterial vaginosis.

For more detail on this trial, and information on how to participate,
please visit https://clinicaltrials.gov/ct2/show/NCT02766023?term=LACTIN-V&rank=1

About Osel, Inc.

Osel, Inc., a privately held biotechnology company, is focused on the
development and commercialization of a portfolio of Live Biotherapeutic
Products (LBPs) that prevent or treat medical conditions resulting from
a disruption of the human microbiome. In 2003, Osel became one of the
first companies to receive U.S. Food and Drug Administration
authorization to test a live bacterial therapeutic, and the company is a
pioneer in the field of LBPs. The company’s proprietary approach
identifies differences between healthy and disease-related microbiomes
and leverages beneficial microbes to treat problematic disruptions or
dysbioses. Osel’s approach repopulates the disrupted microbiome with
beneficial bacteria that help restore a healthy and protective
microbiota.

Osel’s primary focus is women’s health, with initial areas of interest
including recurrent urinary tract infections and bacterial vaginosis.
Osel is based in Mountain View, CA. For more information, please visit
the company’s website at http://oselinc.com

Contacts

For patients:
https://clinicaltrials.gov/ct2/show/NCT02766023?term=LACTIN-V&rank=1
or
For
general inquiries:
info@oselinc.com
or http://oselinc.com
or
For
media:
Joan Kureczka, 1-415-821-2413
Joan@bioscribe.com