Armata Pharmaceuticals has posted early validation of its phage platform. The phase 1b/2a trial linked a bacteriophage cocktail to improved outcomes in patients with bacteria in their blood, opening the door to further study of a modality that could address the limitations of antibiotics.
Interest in therapeutic uses of bacteriophages, viruses that infect and replicate in bacteria, has increased in recent years as antibiotic resistance has spread. Armata is part of a band of biotechs working to show the signs of efficacy seen in compassionate use cases can be replicated in clinical trials. Monday, Armata shared clinical data from a trial of people with Staphylococcus aureus in their blood.
The efficacy endpoints looked at patients with complicated S. aureus bacteremia in the phase 2a portion of the trial. Participants received placebo or AP-SA02, Armata’s phage therapy, on top of best available antibiotic therapy.
At Day 12, the investigator-assessed responder rate was 88% on AP-SA02 versus 58% on placebo. Armata also looked at the responder rate one and four weeks after the end of antibiotic therapy. At both times, the responder rate was 100% on AP-SA02 compared to 75% in the control group.
The AP-SA02 response rate was 100% in patients sensitive and resistant to the antibiotic methicillin. The resistant form of infection, MRSA, is a global health threat. Across all the endpoints, the biotech saw similar response rates when clinical outcomes were assessed by the investigator or by the doctors on its clinical efficacy adjudication committee.
Armata included (PDF) 42 people in its phase 2a safety population. The intent-to-treat efficacy analyses, which Armata said included all subjects that received antibiotic therapy and at least one dose of AP-SA02 or placebo, looked at between 28 and 36 patients.
The readout is part of a series of data drops on phage therapies. BiomX shared drug data on its candidate in diabetic bone ulcers in March. Phaxiam Therapeutics has published clinical data, too, but is now seeking a buyer. Armata, which received U.S. government funding for the AP-SA02 trial, ended March with $11.7 million.