Armata Pharmaceuticals Announces First Patient Dosed in the Phase 2a Portion of the Phase 1b/2a 'diSArm' Study of AP-SA02 in Adults with Bacteremia Due to Staphylococcus aureus
Initiation of the Phase 2a portion follows DRC review of positive safety and tolerability data from recently completed Phase 1b portion
Study being conducted in partnership with the U.S. Department of Defense
LOS ANGELES, Sept. 26, 2023 /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 Phase 2a portion of the Company's diSArm study of AP-SA02 as a potential treatment for Staphylococcus aureus bacteremia. Initiation of the Phase 2a portion of the study follows Data Review Committee (DRC) review of positive safety and tolerability data from the Phase 1b portion.
"We are very pleased to be able to advance our second clinical phage candidate, AP-SA02, into the Phase 2a portion of this important study as we look to demonstrate its efficacy as an adjunct to current standards of care," stated Dr. Deborah Birx, MD, Chief Executive Officer of Armata. "We are grateful for the continued support from our partners at the Department of Defense, our site investigators and the volunteers participating in the study as we look to introduce an effective and synergistic new treatment option to combat S. aureus, a pathogen associated with high mortality rates due to its documented ability to develop resistance to even the strongest currently available antibiotics. Combatting antimicrobial resistance is critical to our collective future."
"S. aureus bacteremia can seed to virtually any body site, resulting in devastating complications," stated Dr. Mina Pastagia, MD, Chief Medical Officer at Armata. "Prompt identification of portal of entry and treatment of metastatic foci are essential. Although many anti-staphylococcal antibiotics have been developed over the past decades, infection with S. aureus continues to result in severe morbidity and mortality, creating a platform for alternative therapies such as phage. AP-SA02 has demonstrated potent in vitro antimicrobial and biofilm activity, as well as a favorable safety and tolerability profile after intravenous administration for multiple days in human subjects. Clinical trial data are needed to substantiate the safety and efficacy of phage therapy before it can be integrated into standard clinical care, and we are optimistic that we will be able to replicate these promising results in the Phase 2a portion of our diSArm study and enable a paradigm shift in the treatment of S. aureus bacteremia."
The diSArm study is a Phase 1b/2a, 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.
This study is being conducted in two phases: Phase 1b evaluated the safety and tolerability of multiple ascending intravenous doses of AP-SA02 or placebo as an adjunct to best available therapy (BAT) compared to BAT alone in subjects with SA bacteremia (SAB). The Phase 2a is evaluating the efficacy, safety, and tolerability of multiple doses of AP-SA02 or placebo as an adjunct to BAT compared to BAT alone in subjects with complicated SAB. The study will enroll approximately 50 subjects.
Armata has received a $16.3 million award to advance development of AP-SA02 from the Department of Defense through the Medical Technology Enterprise Consortium (MTEC) managed by the Naval Medical Research Command with funding from the Defense Health Agency and Joint Warfighter Medical Research Program.
For more information on the diSArm study, see NCT05184764.
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. 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 as defined by the Private Securities Litigation Reform Act of 1995, 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 future success or failure, 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, Armata's ability to develop new products based on natural bacteriophages and synthetic bacteriophages, and Armata's ability to obtain additional funding and capacity to repay, refinance, or restructure its existing debt and obligations. 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; that the top line results are indicative of the final data; Armata's ability to expedite development of AP-PA02 and AP-SA02; 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 16, 2023, 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.
View original content to download multimedia:https://www.prnewswire.com/news-releases/armata-pharmaceuticals-announces-first-patient-dosed-in-the-phase-2a-portion-of-the-phase-1b2a-disarm-study-of-ap-sa02-in-adults-with-bacteremia-due-to-staphylococcus-aureus-301937830.html
SOURCE Armata Pharmaceuticals, Inc.
Company Codes: AMEX:ARMP