AmpliPhi Biosciences (APHB) Reports Data From Phase 1 Trial of AB-SA01 Targeting S. Aureus Infections

September 13, 2016 8:48 AM EDT
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AmpliPhi Biosciences Corporation (NYSE: APHB) 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.

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.

For more information, visit www.ampliphibio.com.



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