AmpliPhi Biosciences Completes Enrollment of Its Investigational Phage Therapy Trial Targeting Staphylococcus aureus

SAN DIEGO–(BUSINESS WIRE)–AmpliPhi Biosciences Corporation (NYSEMKT:APHB), a global leader in the
development of bacteriophage-based antibacterial therapies to treat
drug-resistant infections, today announced it has completed enrollment
of its Phase 1 clinical trial to evaluate the safety of AB-SA01, its
proprietary phage cocktail targeting Staphylococcus aureus (S.
aureus) infections. The trial is being conducted under a
Collaborative Research and Development Agreement with the U.S. Army at
the Walter Reed Army Institute of Research (Walter Reed) Clinical Trials
Center in Silver Spring, Maryland. AmpliPhi expects to report topline
results by the end of the third quarter of 2016.
Bacteriophages, or, more simply, “phages”, are naturally-occurring
viruses that have evolved to be highly selective for the bacterial
species they must infect in order to replicate. Successful infection
enables a single phage to hijack a bacterial host’s protein production
machinery to rapidly produce hundreds of progeny phages, at which point
the phage instructs the bacterial cell to burst, scattering the highly
selective progeny into the surrounding environment to attack nearby
bacteria and repeat the reproduction process until the bacterial
population is depleted. Throughout this process the phages maintain
their bacterial species selectivity, enabling a phage-based therapeutic
to precisely target a pathogenic bacterial population while sparing the
beneficial microbiota. Phage can infect and kill bacteria, whether they
are antibiotic-resistant or not and even when they have formed
protective biofilms. Such biofilms are a major line of defense for
bacteria, sometimes rendering them impervious to conventional
antibiotics.
Despite vigorous eradication efforts, S. aureus is one of the
most common causes of hospital-acquired infections. It can cause
pneumonia, infect prosthetic joints, skin and other soft tissues and is
a leading cause of bloodstream infections – typically as a consequence
of traumatic injury, surgery or use of catheters or injectable drugs –
where it can go on to infect and damage the heart, joints and bones.
The double-blinded, placebo-controlled study began on May 24, 2016 and
was designed to evaluate the safety of AB-SA01 administered topically to
the skin of 12 healthy adult volunteers between the ages of 18 and 60.
Volunteers were split into two cohorts of six participants each, and
received either the low-dose (1 x 10⁸ PFU/mL) or high-dose (1
x 10⁹ PFU/mL) of AB-SA01, administered topically to the
forearm under an occlusive bandage. Placebo was similarly administered
to the volunteer’s opposite forearm, allowing each participant to serve
as their own control. Participants received AB-SA01 and placebo daily
for three consecutive days and were monitored following treatment.
“Successfully enrolling the first U.S.-based trial of AB-SA01 marks a
signal achievement by the AmpliPhi team and our partners at Walter Reed
as we work to pioneer the first rigorous human efficacy studies of phage
therapy in the United States,” said M. Scott Salka, CEO of AmpliPhi
Biosciences. “Phage therapy holds the potential to play a critical role
in humanity’s fight against the looming and ever-evolving threat of
antibiotic-resistant bacteria by exploiting a predator-prey relationship
that has been raging since the dawn of life on Earth. We look forward to
completing the necessary follow-up visits and providing more results
soon, and expect to have complete study reports for both this trial as
well as our Phase 1 AB-SA01 trial in patients with chronic
rhinosinusitis later this year.”
For more information, visit www.ampliphibio.com.
About AmpliPhi Biosciences
AmpliPhi Biosciences Corporation (NYSEMKT:APHB) is a biotechnology
company focused on the development and commercialization of novel
bacteriophage-based antibacterial therapeutics. AmpliPhi’s product
development programs target infections that are often resistant to
existing antibiotic treatments. AmpliPhi is currently conducting a Phase
1 clinical trial of AB-SA01 for the treatment of S. aureus in
chronic rhinosinusitis patients and another Phase 1 clinical trial to
evaluate the safety of AB-SA01 when administered topically to the intact
skin of healthy adults. AmpliPhi expects to report final data for both
trials in the second half of 2016. AmpliPhi is also developing
bacteriophage therapeutics targeting Pseudomonas aeruginosa and Clostridium
difficile in collaboration with a number of leading organizations
focused on the advancement of bacteriophage-based therapies.
Forward Looking Statements
Statements in this press release that are not statements of historical
fact are forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Such forward-looking
statements include, without limitation, statements about the expected
timing of reporting data from AmpliPhi’s two AB-SA01 trials, the
potential use of bacteriophages to treat bacterial infections, including
infections that do not respond to antibiotics, the potential benefits of
phage therapy, and AmpliPhi’s development of bacteriophage-based
therapies. Words such as “believe,” “anticipate,” “plan,” “expect,”
“intend,” “will,” “may,” “goal,” “potential” and similar expressions are
intended to identify forward-looking statements, though not all
forward-looking statements necessarily contain these identifying words.
These forward-looking statements are based upon AmpliPhi’s current
expectations and involve a number of risks and uncertainties, including
the risks and uncertainties described in AmpliPhi’s Quarterly Report on
Form 10-Q for the quarter ended March 31, 2016, as filed with the
Securities and Exchange Commission. Actual results and the timing of
events could differ materially from those anticipated in such
forward-looking statements as a result of these risks and uncertainties.
You are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date of this press release. All
forward-looking statements are qualified in their entirety by this
cautionary statement, and AmpliPhi undertakes no obligation to revise or
update any forward-looking statements to reflect events or circumstances
after the date of this press release.