MARINA DEL REY, Calif., Dec. 22, 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 last subject has completed the company's Phase 1b/2a 'SWARM-P.a.' clinical trial of its lead candidate, AP-PA02, in cystic fibrosis (CF) subjects with chronic pulmonary Pseudomonas aeruginosa infection.
"We are very pleased to have completed Armata's first multi-center, double-blind, randomized, placebo-controlled clinical trial evaluating phage therapy in patients," stated Mina Pastagia, MD, MS, Senior Vice President of Clinical Development at Armata. "Successful use of phage therapy has been reported in compassionate use cases, but its translation into standard clinical practice requires rigorous, systematic clinical trials. We look forward to evaluating the clinical data from CF subjects in our SWARM-P.a. study to take Armata one step closer to that goal."
"The completion of SWARM-P.a. represents a critical milestone for our lead program and for Armata. I would like to once again express Armata's gratitude to the Cystic Fibrosis Foundation for its ongoing support and guidance," stated Dr. Brian Varnum, Chief Executive Officer of Armata. "This trial will provide critical information regarding inhaled delivery of phage, importantly, assessment of safety and tolerability of phage therapy in the CF population. Additionally, this first-in-human Phase 1b/2a study will provide critical insights for dosing paradigms required to meet microbiological endpoints. We anticipate topline data in the first quarter of 2023."
In March 2020, Armata announced that it had been awarded up to $5 million in a therapeutic development award from the CF Foundation to advance development of AP-PA02. In October 2021, the Foundation subsequently made an equity investment of $3 million in Armata to further support this program.
The SWARM-P.a. study is a Phase 1b/2a, multi-center, double-blind, randomized, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial to evaluate the safety and tolerability of inhaled AP-PA02 in subjects with cystic fibrosis and chronic pulmonary Pseudomonas aeruginosa infection. The study has been conducted in collaboration with the Cystic Fibrosis Therapeutics Development Network (TDN), the largest CF clinical trials network. For more information about the trial: NCT04596319.
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.
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.
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