Armata Pharmaceuticals Provides Regulatory and Clinical Update Reflecting Sustained Progress Across Key Phage Therapeutic Development Programs
Armata Pharmaceuticals (NYSE American: ARMP) announced significant progress in its phage therapeutic development programs. The FDA has cleared its IND for the Phase 1b/2a trial of AP-SA02 targeting Staphylococcus aureus bacteremia, expected to start by year-end. Additionally, a $2 million milestone under the CF Foundation's Therapeutics Development Award has been achieved, raising the total to $3.75 million. The company is focused on combating drug-resistant bacterial infections with support from the Cystic Fibrosis Foundation and U.S. Department of Defense.
- FDA clearance for AP-SA02 Phase 1b/2a clinical trial.
- Achievement of $2 million milestone under CF Foundation's award, totaling $3.75 million.
- None.
MARINA DEL REY, Calif., Nov. 18, 2021 /PRNewswire/ -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata," "us," "our," or the "Company"), a biotechnology company focused on pathogen-specific bacteriophage therapeutics for antibiotic-resistant and difficult-to-treat bacterial infections, today provided an update on its development programs reflecting sustained clinical progress and a strengthened financial position.
"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
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
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
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 its bacteriophage-based technology 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 successfully 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 outbreak of COVID-19. 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 18, 2021, 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:
Steve Martin
Armata Pharmaceuticals, Inc.
ir@armatapharma.com
858-800-2492
Armata Investor Relations:
Joyce Allaire
LifeSci Advisors, LLC
jallaire@lifesciadvisors.com
212-915-2569
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