Armata Pharmaceuticals Announces Completion of Enrollment of Phase 2 Tailwind Study of Inhaled AP-PA02 in Non-Cystic Fibrosis Bronchiectasis Subjects with Chronic Pulmonary Pseudomonas aeruginosa Infection
Armata Pharmaceuticals (ARMP) has completed enrollment for its Phase 2 Tailwind study of inhaled AP-PA02 in non-cystic fibrosis bronchiectasis (NCFB) patients with chronic pulmonary Pseudomonas aeruginosa infection. The study, which follows the successful SWARM-P.a. trial in cystic fibrosis patients, evaluates the safety, tolerability, and efficacy of AP-PA02. Topline results are expected in the second half of 2024, with plans to commence a pivotal Phase 3 trial in 2025. The study includes two cohorts: one receiving phage-only therapy and another receiving a combination with inhaled antibiotics. The final follow-up visit is scheduled for August 7, 2024.
- Completion of enrollment for Phase 2 Tailwind study.
- Topline data anticipated in 2H 2024.
- Potential initiation of pivotal Phase 3 trial in 2025.
- Study includes optimized dosing regimen for better clinical safety and efficacy.
- No current data on efficacy or safety; awaiting results in 2H 2024.
- Potential delays or setbacks in future Phase 3 trial.
Insights
From a clinical research perspective, the completion of enrollment for Armata Pharmaceuticals' Phase 2 Tailwind study is a pivotal step in the development of inhaled AP-PA02 for non-cystic fibrosis bronchiectasis (NCFB) patients suffering from chronic pulmonary Pseudomonas aeruginosa infections. This study's structure—dividing participants into cohorts receiving either phage-only therapy, phage plus antibiotics, or placebo—allows for a nuanced understanding of AP-PA02's efficacy and safety. Notably, the primary endpoint revolves around the reduction of P. aeruginosa in sputum, which is critical given the pathogen’s resistance to conventional antibiotics.
The previous successful evaluation in cystic fibrosis patients (SWARM-P.a.) gives added confidence, particularly with the optimized dosing regimen incorporated into this study. Should the Phase 2 results be positive, this could validate the use of bacteriophage therapy as a groundbreaking intervention in treating chronic bacterial respiratory infections. For retail investors, this signifies potential long-term value as success could lead to fast-tracked pivotal trials and eventual market approval.
From a financial standpoint, the efficient enrollment in the Tailwind study reflects positively on Armata Pharmaceuticals' operational capabilities and adherence to projected timelines. Investors should note the anticipated topline data release in the second half of 2024. Positive results could significantly boost Armata’s stock, especially considering the market for novel anti-infectives targeting antibiotic-resistant bacteria. However, investors need to consider the inherent risks of clinical trials, including potential delays or unfavorable outcomes.
Moreover, the planned initiation of a Phase 3 trial in 2025 underscores the company's committed pipeline progression, which could attract additional investment and partnerships. Retail investors should keep a close watch on interim updates and any preliminary efficacy signals, as these could provide early indicators of the trial’s success and subsequent financial implications.
Tailwind is evaluating inhaled AP-PA02 in non-cystic fibrosis bronchiectasis (NCFB), its second patient population, following successful evaluation in patients with cystic fibrosis (SWARM-P.a.) in 2023
Phase 2 Topline data anticipated in 2H 2024 followed by potential initiation of a pivotal bronchiectasis trial in 2025
"We are pleased to have efficiently enrolled this important study according to our internal timelines as we continue to add to the growing body of evidence demonstrating the value of phage therapy in treating chronic bacterial respiratory infections," stated Dr. Deborah Birx, Chief Executive Officer of Armata. "In this study, we enrolled a cohort of patients without prior or current inhaled antibiotics, allowing for the evaluation of phage-only therapy compared to placebo, in addition to a cohort of patients receiving inhaled phage plus antibiotics. We look forward to sharing topline data as soon as it becomes available and plan to meet with the FDA shortly thereafter on the design of a pivotal Phase 3 study, which we are planning to initiate in 2025. We remain committed to the execution of rigorously designed randomized trials that, if successful, will support registration of our phage candidates."
"The success of our completed SWARM-P.a. study of inhaled AP-PA02 in cystic fibrosis patients with chronic pulmonary P. aeruginosa infection provided important learnings that we incorporated into the design of Tailwind," stated Mina Pastagia, MD, MS, Chief Medical Officer of Armata. "Notably, the Tailwind study includes an optimized dosing regimen that gives us confidence in our ability to demonstrate clinical safety, while evaluating the durability of P. aeruginosa reduction in the lungs. We look forward to evaluating the clinical data from Tailwind as we work diligently to introduce a sorely needed pathogen-specific class of anti-infectives to patients with bronchiectasis and chronic P. aeruginosa infections."
The Tailwind study is a Phase 2, multi-center, double blind, randomized, placebo-controlled trial evaluating the safety, tolerability, and efficacy of inhaled AP-PA02 as monotherapy, as well as in combination with inhaled antibiotics in subjects with NCFB and chronic pulmonary P. aeruginosa infection. The primary endpoint is P. aeruginosa recovery in sputum following multiple doses of AP-PA02 administered by inhalation.
For more information: https://clinicaltrials.gov/study/NCT05616221
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 therapy with drug development expertise that spans bench to clinic including in-house phage specific cGMP manufacturing.
Forward Looking Statements
This communication contains "forward-looking" statements as defined by the Private Securities Litigation Reform Act of 1995. These statements relate to future events, results or to Armata's future financial performance and involve known and unknown risks, uncertainties and other factors which may cause Armata's actual results, performance or events to be materially different from any future results, performance or events expressed or implied by the forward-looking statements. In some cases, you can identify these statements by terms such as "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "will," "would" or the negative of those terms, and similar expressions. These forward-looking statements reflect management's beliefs and views with respect to future events and are based on estimates and assumptions as of the date of this communication and are subject to risks and uncertainties including risks related to Armata's development of bacteriophage-based therapies; ability to staff and maintain its production facilities under fully compliant current Good Manufacturing Practices; ability to meet anticipated milestones in the development and testing of the relevant product; ability to be a leader in the development of phage-based therapeutics; ability to achieve its vision, including improvements through engineering and success of clinical trials; ability to successfully complete preclinical and clinical development of, and obtain regulatory approval of its product candidates and commercialize any approved products on its expected timeframes or at all; and Armata's estimates regarding anticipated operating losses, capital requirements and needs for additional funds. 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 21, 2024, 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
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.
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