Armata Pharma Gets FDA IND Clearance For AP-SA02 In Prosthetic Joint Infection

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Armata Pharmaceuticals, Inc. (ARMP) announced Monday that the U.S. Food and Drug Administration has cleared its Investigational New Drug or IND application for AP-SA02 in prosthetic joint infection or PJI.

The clinical-stage biotechnology company focused on the development of precisely targeted bacteriophage therapeutics is initiating start-up activities for the Phase 1b/2a trial.

The planned trial will explore the safety, tolerability, and pharmacokinetics of intravenous and intra-articular doses of AP-SA02 as an adjunct to standard of care antibiotics in subjects with PJI.

Mina Pastagia, Armata's Senior Vice President of Clinical Development, said, "Prosthetic joint infection is one of the most serious complications of prosthetic joint implantation. Staphylococcus aureus is a dominant pathogen that drives the need for surgical intervention and prolonged courses of antibiotic therapy. The ability of S. aureus to create biofilms that are refractory to standard of care antibiotics highlights the need for a novel therapy."

With this IND approval, Armata now has four active clinical programs.

In addition to evaluating AP-SA02 in PJI and bacteremia due to S. aureus, Armata has advanced AP-PA02 into the Phase 2a component of the SWARM-P.a. study which targets chronic Pseudomonas aeruginosa infections in people with cystic fibrosis (CF).

In February, the company gained IND clearance for AP-PA02 in a second indication, non-cystic fibrosis bronchiectasis (NCFB) targeting patients with chronic P. aeruginosa infections in a Phase 2 trial.

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