SAN DIEGO--(EON: Enhanced Online News)--AmpliPhi Biosciences Corporation (NYSE MKT:APHB), a global leader in the development of bacteriophage-based antibacterial therapies to treat drug-resistant infections, today reported final results from its Phase 1 trial to evaluate the safety and tolerability of AB-SA01, its proprietary investigational phage cocktail targeting Staphylococcus aureus (S. aureus) infections. Overall, treatment with AB-SA01 was well tolerated when administered topically to the intact skin of healthy adults. The trial was conducted under a Collaborative Research and Development Agreement with the U.S. Army at the Walter Reed Army Institute of Research Clinical Trials Center in Silver Spring, Maryland.
“We are extremely pleased and encouraged by the final results from this trial, which demonstrated that AB-SA01 was well tolerated by healthy volunteers”
“We are extremely pleased and encouraged by the final results from this trial, which demonstrated that AB-SA01 was well tolerated by healthy volunteers,” said M. Scott Salka, CEO of AmpliPhi Biosciences. “We believe these results provide strong support for the advancement of AB-SA01 into the first phage therapy Phase 2 trial in 2017. Our corporate goal was to report final data from our Phase 1 trial before the end of 2016 and we met that objective through the hard work of the entire AmpliPhi team as well as our partners at the Walter Reed Army Institute of Research. Additionally, we remain on track to finalize data by the end of 2016 from our other Phase 1 trial of AB-SA01, targeting S. aureus infections in patients suffering from chronic rhinosinusitis. We look forward to discussing these data during our business update call on January 4, 2017.”
The double-blind, placebo-controlled study evaluated the safety of AB-SA01 administered topically to the intact skin of 12 healthy volunteers between the ages of 18 and 60. Volunteers were assigned to receive either a low dose (1 x 108 PFU/mL) or a high dose (1 x 109 PFU/mL) of AB-SA01, administered topically to the forearm. Placebo was similarly administered to the volunteer’s opposite forearm, allowing each participant to serve as his or her own control. The application sites were covered by an occlusive dressing for 24 hours. Participants received AB-SA01 and placebo daily for three consecutive days and were monitored for approximately two weeks following treatment.
Key findings from the study showed:
- No subject had a treatment-emergent adverse event (TEAE) that was considered definitely or probably related to AB-SA01
- There were no severe or higher grade TEAEs, serious adverse events or discontinuation of treatment due to TEAEs
- Laboratory values and vital sign parameters were within normal ranges
- Treatment with AB-SA01 was well tolerated throughout the study
Despite vigorous eradication efforts, S. aureus is one of the most common causes of hospital-acquired infections. It can cause pneumonia and infect prosthetic joints, skin and other soft tissues. It is also 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.
Conference Call and Webcast
AmpliPhi Biosciences will hold a business update conference call on Wednesday, January 4, 2017 beginning at 4:30 p.m. Eastern time (1:30 p.m. Pacific time). The conference call dial-in number is (877) 287-2401 for domestic callers and (216) 562-0057 for international callers, and the passcode is 30920092. A live webcast of the call will be available on the Investor Relations section of www.ampliphibio.com.
A recording of the call will be available for 48 hours beginning approximately two hours after the completion of the call by dialing (855) 859-2056 for domestic callers and (404) 537-3406 for international callers. Please use passcode 30920092 to access the recording. A webcast replay will be available on the Investor Relations section of www.ampliphibio.com for 30 days, beginning approximately two hours after the completion of the call.
Bacteriophages, or more simply “phages,” are the natural predators of bacteria and are thought to be the most abundant life form on earth, outnumbering even the stars in our universe. Over eons, phages have evolved an incredible diversity of specialist strains that typically prey upon just one strain of bacteria, enabling a phage-based therapeutic to precisely target a pathogenic bacterial population while sparing the beneficial microbiota. Phages 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. Phages are able to penetrate biofilms, producing strong local therapeutic effects without the side-effects commonly produced by antibiotics.
About AmpliPhi Biosciences
AmpliPhi Biosciences Corporation 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 has reported topline results from two Phase 1 clinical trials of AB-SA01, one for the treatment of S. aureus in chronic rhinosinusitis patients and one to evaluate the safety of AB-SA01 when administered topically to the intact skin of healthy adults. AmpliPhi expects to report final data from the chronic rhinosinusitis trial by the end of 2016. AmpliPhi is also developing bacteriophage therapeutics targeting Pseudomonas aeruginosa (P. aeruginosa) and Clostridium difficile (C. difficile) in collaboration with a number of leading organizations focused on the advancement of bacteriophage-based therapies. For more information, visit www.ampliphibio.com.
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 Phase 1 trial evaluating AB-SA01 in chronic rhinosinutis patients, the potential advancement of AB-SA01 into a Phase 2 trial in 2017, 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. Among the factors that could cause actual results to differ materially from those indicated in these forward-looking statements are risks and uncertainties associated with AmpliPhi’s business and financial condition and the other risks and uncertainties described in AmpliPhi’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2016, as filed with the SEC, and other filings with the SEC. 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.