- 7-year-old child acquired antibiotic-resistant chronic Pseudomonas aeruginosa infection of her lower leg following injury sustained in a car accident
- Prior surgical debridement, hardware removal and three months of IV antibiotics had failed to stop the progress of infection – no other medical or surgical options were available.
- Pain-free weight bearing on the affected leg was achieved for the first time since the initial injury, seven weeks after completion of adjunctive phage therapy
- Long-term follow-up demonstrated radiological improvement
GAITHERSBURG, MD, September 9, 2021 – Adaptive Phage Therapeutics, Inc. (APT), a clinical-stage biotechnology company dedicated to providing therapies to treat infectious diseases, today highlights a case study publication in EMBO Molecular Medicine of phage therapy titled,
‘Bacterial lysis, autophagy and innate immune responses during adjunctive phage therapy in a child’
Ameneh Khatami, Ruby C Y Lin, Aleksandra Petrovic-Fabijan, Sivan Alkalay-Oren, Sulaiman Almuzam, Philip N Britton, Michael J Brownstein, Quang Dao, Joe Fackler, Ronen Hazan, Bri’Anna Horne, Ran Nir-Paz, Jonathan R Iredell
Following injuries sustained in a car accident, the patient acquired an osteoarticular Pseudomonas aeruginosa infection, complicating an internal fixation of a traumatic fracture-dislocation. Surgical debridement and hardware removal, as well as three months of intravenously administrated antibiotics failed to stop the pernicious infection. The investigational phage therapy was prepared by APT and utilized in an effort to prevent the amputation of the patient’s infected lower leg. The authors state a significant therapeutic effect was observed within two weeks of starting the adjunctive phage therapy.
In-vitro activity of multiple phage strain candidates were assessed by means of APT’s PhageBank™ Susceptibility Test (PST) to determine the clinically relevant selection. The patient received a 0.9 mL dose of the precision-matched phage intravenously once-daily (for days 1, 2 and 4-7) and twice-daily (for days 3 and 8-14) for two weeks. During treatment, physicians monitored phage and bacterial kinetics, to enable real-time adjustment of dosage.
The study authors stated that the successful phage therapy resulted in an initial flush of bacterial contents into the bloodstream with an inflammatory response marked by fever, local pain and upregulation of genes associated with autophagy and innate immunity. Low-grade fevers were also reported following the second and third phage dose administrations, but none thereafter. Pain-free weight bearing on the affected leg was achieved – for the first time since the initial injury – at seven weeks following completion of this adjunctive phage therapy sequence. Additionally, the patient had no further infective symptoms at five months following completion of treatment. “I am thrilled that this young patient has seen significant clinical resolution from this infection. Antibiotic-resistant bacterial infections are a global health threat. This case is a further clinical proof point demonstrating the potential of precision-matched phage therapy in addressing the growing threat of antimicrobial resistant (AMR) infections,” said Greg Merril, CEO and co-founder of Adaptive Phage Therapeutics. “Beyond early access emergency cases, APT is committed to advancing PhageBank™ therapy to broad market availability and is actively engaged in carefully controlled clinical trials addressing several unmet clinical needs.”
APT provided the phage for this case on compassionate grounds with no financial renumeration
Adaptive Phage Therapeutics, Inc.
Adaptive Phage Therapeutics (APT) is a clinical-stage company advancing therapies to treat multi-drug resistant infections. Prior antimicrobial therapeutic approaches have been ”fixed,” while pathogens continue to evolve resistance to each of those therapeutics, causing those drug products to become rapidly less effective in commercial use as antimicrobial resistance (AMR) increases over time.
APT’s PhageBank™ approach leverages an ever-expanding library of bacteriophage (phage) that collectively provide evergreen broad spectrum and polymicrobial coverage. PhageBank™ phages are matched through a proprietary phage susceptibility assay that APT has teamed with Mayo Clinic Laboratories to commercialize on a global scale.
APT’s technology was originally developed by the biodefense program of U.S. Department of Defense. APT acquired the world-wide exclusive commercial rights in 2017. Under FDA emergency Investigational New Drug allowance, APT has provided investigational PhageBank™ therapy to treat more than 40 critically ill patients in which standard-of-care antibiotics had failed. For more information, visit http://www.aphage.com.
Adaptive Phage Therapeutics
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