Diabetic Foot Osteomyelitis (DFO)

DFO is commonly associated with diabetic foot infections and is associated with significant morbidity and mortality. Failure of the infection to resolve and the ulcer to heal, ultimately leads to amputation of the affected limb. Avoiding amputation is a major goal when treating DFO. The limited effectiveness of antibiotics in the treatment of DFOs is multifactorial. The presence of biofilm and/or vascular insufficiency at the site of infection and the presence of antibiotic resistant bacteria play a role. Phage therapy, in addition to SOC antibiotics, has demonstrated wound closure and healing of DFOs as well as reossification of affected bone [Fish 2016].

APT has seen clinical proof points for APT’s PhageBank and companion diagnostic technology in the treatment of infections related to chronic wounds including involvement of osteomyelitis under FDA emergency Investigational New Drug (eIND) allowance.

APT.DFI.001 is a randomized, double-blind, placebo-controlled, repeat-dose, multi-site trial investigating the safety, tolerability, and efficacy of personalized phage treatment and standard of care in patients with diabetic foot infections due to Staphylococcus aureus. This effort is funded in part through an advanced development contract with the U.S. Defense Health Agency.

Prosthetic Joint Infection (PJI)

Prosthetic Joint Infections (PJI) is a serious complication of joint replacement surgery. Estimates are that approximately 0.5% to 2% of knee prostheses and 0.3% to 1.7% of hip prostheses will become infected over the life of the implant (Zimmerli 2014). The financial burden is staggering; the overall cost to the healthcare system in the US for treating PJI is estimated to exceed $1.62 billion (Kurtz et al 2012). In general, treatment of recalcitrant PJI is limited to the use of two-stage exchange arthroplasty and indefinite chronic oral suppressive antibiotic therapy (SAT), oral SAT without further surgical intervention, arthrodesis, or amputation (Tande and Patel 2014). All of these options have significant life-altering ramifications.

APT has seen several clinical proof points for APT’s PhageBank therapy and phage susceptibility companion diagnostic technology in the treatment of Prosthetic Joint Infections (PJI) and related infections (e.g. osteomyelitis and biofilm-related implanted device infections) under FDA emergency Investigational New Drug (eIND) allowance.

Currently, APT is sponsoring the development of two clinical trials in patients with chronic PJI. These studies are funded in part through an investment from the Mayo Clinic and through collaborations with the University of Maryland and other institutions.

Cystic Fibrosis-related Lung Infection

APT has seen clinical proof points for APT’s PhageBank and companion diagnostic technology in the treatment of lung infections due to Pseudomonas aeruginosa associated with cystic fibrosis under FDA emergency Investigational New Drug (eIND) allowance.

APT, in an agreement with the Antibacterial Resistance Leadership Group (ARLG) and the National Institutes of Health (NIH) National Institute of Allergies and Infectious Disease (NIAID), is supporting a Phase 1b/2, multi-centered, randomized, double-blind, placebo-controlled trial assessing the safety and microbiological activity of a single dose of bacteriophage therapy in cystic fibrosis subjects colonized with Pseudomonas aeruginosa. Under the agreement, APT is providing phage strains acquired under a license from The Walter Reed Army Institute of Research (WRAIR).