Adaptive Phage Therapeutics Announces First Patient Dosed in the DANCE Trial, a Phase 1/2 Study Evaluating APT Phage Bank in Diabetic Foot Osteomyelitis

GAITHERSBURG, Md.--(BUSINESS WIRE)-- Adaptive Phage Therapeutics, Inc. (“APT”), a clinical-stage biotechnology company dedicated to providing therapies to treat infectious diseases, today announced that the first patient has been dosed in its DFO Adaptive Novel Care Evaluation (DANCE™) trial, a Phase 1/2 clinical study to evaluate the safety and efficacy of APT’s precision bacteriophage (“phage”) therapy in patients with Diabetic Foot Osteomyelitis (DFO).

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Vial of phage from APT’s phage bank for evaluation in treatment of bacterial infections. (Photo: Business Wire)

Traditional antibiotic approaches lose effectiveness over time due to bacteria’s inherent ability to evolve resistance. APT’s approach uniquely leverages an ever-growing library of systematically discovered, selected, catalogued, and curated phages, which collectively provide broad coverage against many of the world’s highest priority antibiotic-resistant bacteria. Phages from the APT phage bank are precision-matched to the patient’s infections through a proprietary phage susceptibility test (PST) that APT has teamed with Mayo Clinic Laboratories to commercialize on a global scale.

There are more than 1.5 million patients diagnosed with diabetes worldwide each year. DFO results from soft tissue infections in diabetic patients where the infection spreads into the bone and is the cause of approximately 85% of lower extremity amputations in diabetic patients. The American Diabetes Association estimates that 20% of patients with diabetic foot infections, of which more than 60% have severe infections, have underlying osteomyelitis that left unresolved, places patients at significantly higher risk of amputation.

“DFO can be debilitating for patients and standard of care antibiotics are often not effective. With the initiation of APT’s DANCE clinical trial, we look forward to advancing this novel investigational treatment. We believe there is a significant role that adaptive phage therapy can play in addressing these difficult infections. Our goal is to demonstrate safety and efficacy in carefully controlled studies to address this unmet need and make phage therapy broadly available for this patient population,” said Greg Merril, Chief Executive Officer and Co-Founder of Adaptive Phage Therapeutics. “We anticipate presenting initial clinical data for DFO in 2023.”

Adaptive Phage Therapeutics, Inc.

Adaptive Phage Therapeutics (APT) is a clinical-stage company advancing therapies to treat multi-drug resistant infections. APT has ongoing clinical trials to address substantial unmet patient needs in Prosthetic Joint Infection (PJI) and Diabetic Foot Osteomyelitis (DFO). APT also selectively provides investigational phage therapy, under FDA emergency Investigational New Drug allowance, to treat critically ill patients in which standard-of-care antibiotics have failed.

APT’s technology was originally developed at the National Institutes of Health (NIH) by APT co-founder Carl R. Merril, MD CAPT USPHS (ret), and further advanced within a biodefense program of U.S. Department of Defense. APT acquired world-wide exclusive commercial rights in 2017.

For more information, visit http://www.aphage.com.

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