FDA Clears First Clinical Study for a Polymicrobial Phage Library-Based Treatment for Antibiotic-Resistant Infections

--Three Clinical Sites to Enroll Patients with Recurrent and Complicated Urinary Tract Infections--

GAITHERSBURG, MD, USA I March 12, 2020 IAdaptive Phage Therapeutics (APT), a clinical-stage biotechnology company founded to provide an effective therapeutic response to the global rise of multi-drug resistant (MDR) pathogenic bacteria, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for the clinical development of PhageBank, a personalized bacteriophage therapeutic for the treatment of MDR and complicated bacterial infections. The Phase 1/2 trial represents the first study of an expanding phage library under FDA allowance for a multi-site study of intravenous administration and/or bladder instillation of phage therapy. Beginning in Q2, APT will enroll patients at up to three clinical sites for the evaluation of PhageBank for the treatment of complicated and chronic recurrent urinary tract infections (UTIs).

“FDA clearance of our IND is a significant milestone toward our goal of advancing a durable cure to MDR and complicated infections,” said Greg Merril, Chief Executive Officer and co-founder of APT. “Unlike antibiotics, which offer static therapies for dynamic pathogens and become obsolete from emerging resistance resulting in market-compressing antibiotic stewardship, PhageBank will be the first antimicrobial to increase in spectrum with use – obviating obsolesensce and the need for stewardship. From a business model point-of-view, PhageBank is the anti-antibiotic.”

About the BEUTIFL (“Bacteriophage Evaluation in UTI First Look” ) Clinical Trial

PhageBank will be evaluated in patients with complicated and chronic recurrent urinary tract infections. The trial will be conducted at the James J. Peters VA Medical Center in Bronx, New York, and two other sites in the U.S. The trial is supported in part by the US Department of Defense (DoD) under a $10.2 million advanced development contract. The DoD contract award is designated to make PhageBank phage therapy available to treat MDR and complicated infections.

According to Cmdr. Christopher Duplessis, MD a researcher at Naval Medical Research Center (NMRC), “As antibiotics become less effective, the need for alternative options becomes a matter of significant public health importance,” he said. “Phage therapy was initially developed by NMRC’s Biological Defense Research Directorate (BDRD), in response to MDR and complicated bacterial infections among service members. Recent technological advances, as well as the emerging threat of antibiotic resistance, create a timely opportunity for us to support its broader use. We are proud of the DoD’s role in driving the initial development of this potential therapy and supporting its regulatory pathway to potentially benefit our warfighters and all Americans.”

For more information, please visit www.clinicaltrials.gov, study identifier number NCT04287478.

APT intends to pursue additional indications in the future to combat the growing problem of antibiotic resistance, which, if un-checked, is projected by the World Health Organization to cause 10 million deaths annually by 2050.1

About UTIs

UTIs are common infections of the urethra or bladder, usually caused by bacteria. UTIs occur more frequently in women.2 Symptoms of UTIs may include increased frequency of urination; a persistent urge to urinate; a burning sensation while urinating; cloudy, red, pink or cola-colored urine; pelvic pain or others. Symptoms of UTIs are not always present. Serious complications can occur if the UTI travels to the kidneys.3

About Phages

Phage therapy was first explored as a potential treatment for bacterial infections in the 1920s, but development was put aside with the advent of antibiotics. Phages are naturally occurring bacterial viruses. There are an estimated 10 phages for each bacteria on earth, and each has evolved to eradicate a narrow host range of bacteria. With the growing bacterial resistance to antibiotics, there has been renewed interest in phage therapy.

About PhageBank

In 2017, APT acquired the world-wide exclusive commercial rights to PhageBank™, a carefully screened and purified broad-spectrum library of phage, originally developed by the biodefense program of the U.S. Department of Defense . PhageBank phages are matched in vitro, on a patient-specific basis, to a targeted pathogen. APT is advancing the technology through innovation in bioinformatics, rapid phage-bacteria matching and phage purification methods in an approach capable of providing a precision-matched therapy instantly upon the diagnosis of a drug-resistant pathogen. Over time, PhageBank has been shown to increase in spectrum of coverage, negating the effects of bacterial resistance that increasingly diminish the effectiveness of antibiotics.

In response to ongoing urgent requests from patients with severe infections due to multi-drug resistant pathogens, APT has provided and continues to provide its investigational PhageBank therapy under the FDA’s emergency Investigational New Drug allowance. Data from phage therapy for the first 13 of these cases that were infected with either one or more MDR bacterial species were published in the July 2019 issue of the Journal of Intensive and Critical Care Medicine: “A Case Series of Emergency Investigational New Drug Applications for Bacteriophages Treating Recalcitrant Multi-drug Resistant Bacterial Infections: Confirmed Safety and a Signal of Efficacy.”

Recent scientific advances have enabled bacteria-specific isolation and matching of phage, resulting in a potential fast-acting, cost-effective therapeutic option for multi-drug resistant infections. In nature, phages continue to co-evolve with bacteria, enabling a broad and continually updated universe of potential options for patients with multi-drug resistant infections.

About Adaptive Phage Therapeutics

Adaptive Phage Therapeutics, Inc. (APT) is a clinical-stage company founded to provide an effective therapeutic response to the global rise of multi-drug resistant (MDR) pathogenic bacteria. APT’s core asset is a large and continually expanding phage library (PhageBank™) deployed with a companion diagnostic to achieve rapid response and cost-effective therapy for otherwise recalcitrant bacterial infections. The technology was developed by the biodefense program of U.S. Department of Defense. APT acquired the world-wide exclusive commercial rights in 2017. Under the FDA emergency Investigational New Drug (eIND) allowance, APT has provided investigational PhageBank therapy to treat more than 20 critically ill patients in which standard-of-care antibiotics had failed. For more information, visit http://www.aphage.com.

1https://www.who.int/news-room/detail/29-04-2019-new-report-calls-for-urgent-action-to-avert-antimicrobial-resistance-crisis
2 https://www.nichd.nih.gov/health/topics/urinary/conditioninfo/uti
3 https://www.mayoclinic.org/diseases-conditions/urinary-tract-infection/symptoms-causes/syc-20353447

SOURCE: Adaptive Phage Therapeutics

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