Armata Pharmaceuticals Announces Clearance of IND for Prosthetic Joint Infections
Armata Pharmaceuticals, Inc. (NYSE American: ARMP) has received FDA clearance for its Investigational New Drug (IND) application for AP-SA02, targeting prosthetic joint infections (PJI) caused by Staphylococcus aureus. This marks a significant advancement in Armata's phage therapy development, aimed at improving patient outcomes in antibiotic-resistant infections. The company is initiating a Phase 1b/2a trial to evaluate the safety and efficacy of AP-SA02 as an adjunct therapy. This addition expands Armata's active clinical programs focused on difficult-to-treat bacterial infections.
- FDA clearance obtained for AP-SA02, enabling Phase 1b/2a trial.
- Potential to significantly enhance treatment outcomes for PJI patients.
- Expansion of active clinical programs to include AP-SA02 and ongoing studies for other conditions.
- None.
Second indication for AP-SA02 which targets Staphylococcus aureus including MRSA
Potential to significantly improve PJI patient outcomes
Expands Armata's pursuit of phage therapy as a solution for difficult-to-treat infections
MARINA DEL REY, Calif., August 01, 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 U.S. Food and Drug Administration (FDA) has cleared Armata's Investigational New Drug (IND) application for AP-SA02 in prosthetic joint infection (PJI). The company is initiating start-up activities for the Phase 1b/2a trial that 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.
"Prosthetic joint infection is one of the most serious complications of prosthetic joint implantation," said Dr. Mina Pastagia, Armata's Senior Vice President of Clinical Development. "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. Phage therapy may fill this need for PJI patients as phage have demonstrated the ability to disrupt biofilm and work synergistically with antibiotics."
"Armata is excited to explore AP-PA02 in patients who suffer from complicated joint infections that don't respond adequately to standard of care antibiotics. PJI is a logical extension of our diSArm trial which is targeting complicated S. aureus bacteremia," said Brian Varnum, Chief Executive Officer of Armata. "With this IND approval, Armata now has four active clinical programs. Today marks an important development milestone for Armata and its investors who set a course three years ago to transform phage therapy from a promising new technology to one that is explored in rigorous clinical settings."
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 ("Tailwind" study).
About Armata Pharmaceuticals, Inc.
Armata is a clinical-stage biotechnology company focused on the development of precisely targeted 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 the use of proceeds from the securities offering, Armata's bacteriophage development programs, 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 initiation and advancement of clinical trials of AP-PA02 and AP-SA02, Armata's ability to develop new products based on bacteriophages and synthetic phages, and Armata's expectations for performance of Armata's therapeutic candidates based on Armata's recent nonclinical work. 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 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 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, Ph.D.
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
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