Armata Pharmaceuticals Provides Regulatory and Clinical Update Reflecting Sustained Progress Across Key Phage Therapeutic Development Programs

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Nov. 18, 2021

Announces FDA clearance of IND to initiate Phase 1b/2a clinical trial of AP-SA02 in Staphylococcus aureus bacteremia (“diSArm” Study)
Achieves significant milestone under previously announced therapeutic development award from the Cystic Fibrosis Foundation for continued advancement of Phase 1b/2a SWARM-P.a. clinical trial of AP-PA02 in Pseudomonas aeruginosa infections

“We are very pleased to provide this update, which reflects the momentum that we currently enjoy across our two lead programs,” stated Dr. Brian C. Varnum, Chief Executive Officer of Armata Pharmaceuticals. “Importantly, the non-dilutive financial assistance that we are receiving from both the Cystic Fibrosis (CF) Foundation and the U.S. Department of Defense (DoD) helps to ensure that we continue to execute meaningful clinical studies that will allow us to introduce new, more effective treatment options to those suffering from drug resistant bacterial infections.”

“While the emergence of drug-resistant bacterial infections has long been a global health challenge, certain bacterial pathogens are proving to be particularly problematic due to their ability to acquire adaptive mutations that render conventional antibiotics less effective,” stated Mina Pastagia, M.D., Vice President of Clinical Development at Armata. “Our decision to focus on Pseudomonas aeruginosa and Staphylococcus aureus with our first two clinical programs reflects our commitment to introduce new solutions where patients most need improved outcomes. We look forward to data from these trials and we are optimistic that the results will be consistent with the compelling observations made during our pre-clinical work.”

AP-SA02: Announces IND acceptance for phase 1b/2a clinical trial
Armata announced today that its Investigational New Drug (IND) application has been cleared by the U.S. Food and Drug Administration (FDA), permitting the company to initiate a Phase 1b/2a clinical study of AP-SA02 in Staphylococcus aureus bacteremia. Armata expects to initiate the study by the end of this year.

The trial, known as diSArm, will be Armata’s second program to enter clinical development. The study will be funded in part by a $15 million award from the U.S. DoD through the Medical Technology Enterprise Consortium (MTEC) with funding from the Defense Health Agency and Joint Warfighter Medical Research Program.

The diSArm study will be a Phase 1b/2a, multi-center, randomized, double-blind, placebo-controlled, multiple ascending dose escalation study of the safety, tolerability, and efficacy of intravenous AP-SA02 as an adjunct to best available antibiotic therapy compared to best available antibiotic therapy alone for the treatment of adults with bacteremia due to Staphylococcus aureus.

AP-PA02: Announces achievement of $2 million milestone under Cystic Fibrosis Foundation Therapeutics Development Award
Armata also announced today the achievement of a significant development milestone under the Therapeutics Development Award from the CF Foundation to support Armata’s ongoing Phase 1b/2a SWARM-P.a. clinical trial evaluating its lead therapeutic candidate, AP-PA02, as a potential treatment for Pseudomonas aeruginosa upper airway infections in cystic fibrosis patients. The latest milestone achievement triggers a $2 million payment bringing the total to $3,750,000 achieved under the Award. In addition, the CF Foundation recently made a $3 million equity investment in Armata.