AmpliPhi Bio Announces Topline Results From Its Phase I Phage Therapy Trial Conducted In The United States

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 topline data from a Phase 1 trial to evaluate the safety and tolerability of AB-SA01, its proprietary investigational phage cocktail targeting Staphylococcus aureus (S. aureus) infections. A safety committee reviewed the trial data and concluded AB-SA01 was well-tolerated by subjects in the trial and there were no drug-related serious adverse events.

“Announcing topline results for the first U.S.-based trial of AB-SA01 is a significant and necessary step towards unlocking the commercial potential of phage therapy to combat antibiotic-resistant bacteria”

The trial was conducted under a Collaborative Research and Development Agreement with the U.S. Army at the Walter Reed Army Institute of Research (WRAIR) Clinical Trials Center in Silver Spring, Maryland. AmpliPhi expects the complete study report will be finalized before the end of 2016.

“Announcing topline results for the first U.S.-based trial of AB-SA01 is a significant and necessary step towards unlocking the commercial potential of phage therapy to combat antibiotic-resistant bacteria,” said M. Scott Salka, CEO of AmpliPhi Biosciences. “We thank our collaborators at WRAIR, and look forward to announcing the complete data from this trial, as well as final data from our Phase 1 trial of AB-SA01 in patients with chronic rhinosinusitis, later this year.”

The double-blind, placebo-controlled study 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 his or her own control. Participants received AB-SA01 and placebo daily for three consecutive days and were monitored following treatment.

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.

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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 by the end 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.

About Bacteriophage

Bacteriophage are naturally occurring viruses that are highly specific for the bacterial hosts they infect. They can rapidly kill their host, amplifying themselves in the process. Bacteriophage are unaffected by antibiotic resistance and are able to disrupt bacterial biofilms. Such biofilms are a major line of defense for bacteria, contributing to antibiotic resistance. Bacteriophage are able to penetrate biofilms and replicate locally to high levels, to produce strong local therapeutic effects.

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, the expected timing for reporting final data from AmpliPhi’s ongoing AB-SA01 trials, the potential use of bacteriophages to treat bacterial infections, including infections that do not respond to antibiotics, 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 June 30, 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.