Armata Pharmaceuticals Announces First Patient Dosed in Phase 1b/2a 'diSArm' Study of AP-SA02 in Adults with Bacteremia due to Staphylococcus aureus

Rhea-AI Summary

Armata Pharmaceuticals (NYSE American: ARMP) announced a significant milestone with the first patient dosed in its Phase 1b/2a clinical trial of AP-SA02, targeting complicated Staphylococcus aureus bacteremia. This study, developed in partnership with the US Department of Defense, aims to evaluate the safety and tolerability of AP-SA02 alongside standard antibiotics. In prior preclinical studies, AP-SA02 showed strong antimicrobial activity against 95% of evaluated S. aureus clinical isolates. The initiative is supported by a $15 million award from the DoD, emphasizing the need for innovative therapies in combating antibiotic-resistant infections.

Positive

• First patient dosed in Phase 1b/2a trial of AP-SA02, indicating progress in clinical development.
• AP-SA02 demonstrated potent antimicrobial activity against 95% of S. aureus clinical isolates in preclinical studies.
• Study supported by a $15 million award from the US Department of Defense, enhancing credibility and funding.

Negative

• None.

Study conducted in partnership with the US Department of Defense

MARINA DEL REY, Calif., May 23, 2022 /PRNewswire/ -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a biotechnology company focused on pathogen-specific bacteriophage therapeutics for antibiotic-resistant and difficult-to-treat bacterial infections, today announced that the first patient has been dosed in the company's Phase 1b/2a clinical trial ('diSArm') of AP-SA02, which is being developed for the treatment of complicated Staphylococcus aureus bacteremia.

"The dosing of the first patient in Armata's diSArm study represents a critical milestone in targeting a dangerous pathogen," stated Dr. Brian Varnum, Chief Executive Officer of Armata. "We are excited to initiate dosing with our second phage product candidate, expanding the exploration of phage benefit in difficult-to-treat infections. The Armata team has worked diligently, along with our partners at the U.S. Department of Defense (DoD), to potentially bring this new therapy to patients with high unmet need."

In June 2020, Armata received a $15 million award from the DoD through the Medical Technology Enterprise Consortium (MTEC) managed by the Naval Medical Research Center with funding from the Defense Health Agency and Joint Warfighter Medical Research Program, to evaluate safety and tolerability of AP-SA02 as an adjunct to best available antibiotic therapy. 

"Staphylococcus aureus bloodstream infections are associated with mortality rates as high as 40% despite the use of powerful, standard of care antibiotics," stated Mina Pastagia, MD, Senior Vice President of Clinical Development at Armata. "The pathogen has developed several strategies to adapt to the infected host, including forming biofilms that have increased tolerance against traditional antibiotics, resulting in refractory and relapse infections. In pre-clinical studies, AP-SA02 demonstrated potent antimicrobial activity against approximately 95% of S. aureus clinical isolates evaluated, including drug-resistant strains, and, we believe, due to its potency and biofilm activity, may offer synergistic benefits when used with standard of care antibiotics – something we hope to demonstrate in this and future studies."

About Armata Pharmaceuticals, Inc.

Armata is a clinical-stage biotechnology company focused on the development of pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections using its proprietary bacteriophage-based technology. Armata is developing and advancing a broad pipeline of natural and synthetic phage candidates, including clinical candidates for Pseudomonas aeruginosa, Staphylococcus aureus, and other pathogens. In addition, in collaboration with Merck, known as MSD outside of the United States and Canada, Armata is developing proprietary synthetic phage candidates to target an undisclosed infectious disease agent. Armata is committed to advancing phage with drug development expertise that spans bench to clinic including in-house phage specific GMP manufacturing. 

Forward Looking Statements

This communication contains "forward-looking" statements, including, without limitation, statements related to Armata's bacteriophage development programs, Armata's ability to set up or operate R&D and manufacturing facilities, Armata's ability to meet expected milestones, Armata's ability to be a leader in the development of phage-based therapeutics, and statements related to the timing and results of clinical trials, including the anticipated results of clinical trials of AP-PA02 and AP-SA02, and Armata's ability to develop new products based on bacteriophages and synthetic phages. Any statements contained in this communication that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements are based upon Armata's current expectations. Forward-looking statements involve risks and uncertainties. Armata's actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to the ability of Armata's lead clinical candidates, AP-PA02 and AP-SA02, to be more effective than previous candidates; Armata's ability to expedite development of AP-PA02; Armata's ability to advance its preclinical and clinical programs and the uncertain and time-consuming regulatory approval process; Armata's ability to develop products based on bacteriophages and synthetic phages to kill bacterial pathogens; the Company's expected market opportunity for its products; Armata's ability to sufficiently fund its operations as expected, including obtaining additional funding as needed; and any delays or adverse events within, or outside of, Armata's control, caused by the ongoing COVID-19 pandemic. Additional risks and uncertainties relating to Armata and its business can be found under the caption "Risk Factors" and elsewhere in Armata's filings and reports with the SEC, including in Armata's Annual Report on Form 10-K, filed with the SEC on March 17, 2022, and in its subsequent filings with the SEC.

Armata expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Armata's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. 

Media Contacts:

At Armata:
Pierre Kyme
Armata Pharmaceuticals, Inc.
ir@armatapharma.com
310-665-2928 x234

Investor Relations:
Joyce Allaire
LifeSci Advisors, LLC
jallaire@lifesciadvisors.com
212-915-2569

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SOURCE Armata Pharmaceuticals, Inc.

FAQ

What is the Phase 1b/2a diSArm trial of AP-SA02 by Armata Pharmaceuticals?

The Phase 1b/2a diSArm clinical trial is designed to evaluate the safety and tolerability of AP-SA02 for treating complicated Staphylococcus aureus bacteremia.

What were the results of AP-SA02 in preclinical studies?

AP-SA02 showed potent antimicrobial activity against approximately 95% of evaluated clinical isolates of S. aureus, including drug-resistant strains.

What is the significance of the $15 million award from the DoD for Armata Pharmaceuticals?

The $15 million award from the US Department of Defense supports the development of AP-SA02 as a therapy for serious infections, aiding research and potential commercialization.

What is Armata's focus in biopharmaceuticals?

Armata Pharmaceuticals focuses on developing pathogen-specific bacteriophage therapeutics to combat antibiotic-resistant and difficult-to-treat bacterial infections.