AmpliPhi Bio Reports Favorable Final Results From Phase 1 Trial Of AB-SA01 In Chronic Rhinosinusitis Patients

SAN DIEGO--(BUSINESS WIRE)--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 of AB-SA01, a proprietary investigational bacteriophage (phage) cocktail targeting Staphylococcus aureus (S. aureus) infections, in patients with chronic rhinosinusitis (CRS). AB-SA01 met the trial’s primary endpoints of safety and tolerability and all nine patients enrolled in the study experienced a reduction in the quantity of S. aureus infecting their sinuses, with some patients showing complete eradication of the bacterial infection.

“We are delighted with the final results of this trial and are particularly encouraged that we saw a decrease in S. aureus bacterial load in all patients treated with AB-SA01”

Key findings from the study include:

• Primary endpoints of safety and tolerability were met
• All patients experienced a reduction in S. aureus bacterial load at the end of the study compared to baseline
• Comparison of pre- and post-treatment endoscopic images showed symptomatic improvement, including reductions in mucosal edema, discharge and polyps
• All enrolled patients completed the trial

“We are delighted with the final results of this trial and are particularly encouraged that we saw a decrease in S. aureus bacterial load in all patients treated with AB-SA01,” said M. Scott Salka, CEO of AmpliPhi Biosciences. “The fact that the patients enrolled in this study had all failed standard of care treatment, including previous sinus surgery, combined with compelling preclinical results in an animal model of CRS and these positive Phase 1 findings, gives us tremendous confidence in our decision to advance AB-SA01 into a Phase 2 trial in 2017.”

The Phase 1 clinical trial in patients with CRS was initiated in January 2016 and was conducted at the Queen Elizabeth Hospital in Adelaide, Australia in collaboration with the University of Adelaide and Flinders University. All nine patients enrolled received AB-SA01 in one of three dose regimens: Cohort 1 patients received low-dose twice daily for seven days; Cohort 2 patients received low-dose twice daily for 14 days; and Cohort 3 patients received high-dose twice daily for 14 days.

Detailed results from the Phase 1 trial of AB-SA01 in CRS patients will be presented by Dr. Mian Ooi, of the University of Adelaide and The Queen Elizabeth Hospital’s department of Otolaryngology, Head and Neck Surgery, at an upcoming medical conference in 2017.

CRS is defined as a single sinusitis episode that lasts more than 12 weeks. This condition affects approximately 30 million adults in the U.S. each year. Patients with CRS experience quality-of-life scores that are often worse than those suffering from congestive heart failure or chronic back pain. Current care includes nasal washes, steroids and antibiotics. Patients who do not respond to these treatments often require invasive sinus surgery to improve sinus drainage. An estimated 300,000 such surgeries are performed in the U.S. annually with infection returning in about 20% of those patients. These unresponsive patients often have no option beyond another sinus surgery that could lead to a similar outcome. AmpliPhi’s goal is to provide these patients with an effective treatment option.

Conference Call and Webcast

As previously announced, 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.

About Bacteriophages

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 effectively infect and kill bacteria, regardless of 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 that phages are able to penetrate to produce strong local therapeutic effects without the side-effects commonly associated with conventional 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 final 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 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 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.