Armata Pharmaceuticals Announces Clearance of Investigational New Drug Application to Initiate Phase 2 Clinical Trial of AP-PA02 in Non-Cystic Fibrosis Bronchiectasis

Rhea-AI Summary

Armata Pharmaceuticals (NYSE American: ARMP) announced FDA clearance for its Investigational New Drug application to initiate a Phase 2 clinical trial of AP-PA02 for non-cystic fibrosis bronchiectasis (NCFB). This condition, often linked to lung infections, currently has no approved treatments. The trial aims to assess the efficacy of AP-PA02 against Pseudomonas aeruginosa infections. Additionally, Armata is advancing other candidates for various bacterial infections, supported by recent financing.

Positive

• FDA clearance for AP-PA02 to treat non-cystic fibrosis bronchiectasis.
• No existing approved therapies for NCFB, presenting a significant market opportunity.
• Plans to initiate Phase 2 clinical trial in 2022.

Negative

• None.

MARINA DEL REY, Calif., Feb. 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 U.S. Food and Drug Administration ("FDA") has cleared Armata's Investigational New Drug (IND) application to initiate a clinical trial of its optimized lead therapeutic candidate, AP-PA02, in a second indication, non-cystic fibrosis bronchiectasis ("NCFB"). The company plans to initiate a Phase 2 trial in 2022.   

In patients with NCFB, lung infection with Pseudomonas aeruginosa is often associated with frequent pulmonary exacerbations, reduced quality of life, and increased mortality, and may require hospital admission for treatment. Although chronic inhaled antibiotics are recommended for long-term management of NCFB with frequent exacerbations, there is currently no approved therapy.

"We are excited to gain FDA clearance to advance AP-PA02 into second respiratory indication," said Brian Varnum, Chief Executive Officer of Armata. "With this regulatory approval and our recent financing, we are well positioned to explore the clinical benefit of AP-PA02, and to advance AP-SA02 for prosthetic joint infections and AP-PA03 for pneumonia."       

In addition to the upcoming trial of AP-PA02 in NCFB, Armata is also conducting a Phase 1b/2a trial ('SWARM-P.a.') of AP-PA02 targeting Pseudomonas aeruginosa infections in cystic fibrosis patients, and a Phase 1b/2a trial ('diSArm') of AP-SA02 targeting Staphylococcus aureus bacteremia. 

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 and the sufficiency of such proceeds to finance the entire development process of AP-PA02 and AP-SA02, 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; 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, 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

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 significance of the FDA's clearance for Armata Pharmaceuticals?

The FDA's clearance allows Armata to advance AP-PA02 into a Phase 2 trial for treating non-cystic fibrosis bronchiectasis, filling a gap for a condition without approved therapies.

What is AP-PA02 and how does it relate to Pseudomonas aeruginosa?

AP-PA02 is Armata's therapeutic candidate aimed at targeting Pseudomonas aeruginosa infections, which are common in patients with non-cystic fibrosis bronchiectasis.

When will the Phase 2 trial for AP-PA02 begin?

Armata Pharmaceuticals plans to initiate the Phase 2 clinical trial of AP-PA02 in 2022.

What are the potential implications of the clinical trial results for ARMP stock?

Positive trial results could enhance investor confidence and potentially increase the stock price, given the significant unmet medical need in treating NCFB.