Armata Pharmaceuticals Announces Encouraging Results from the Phase 2 Tailwind Study of Inhaled AP-PA02 in Non-Cystic Fibrosis Bronchiectasis Subjects with Chronic Pulmonary Pseudomonas aeruginosa Infection
Armata Pharmaceuticals (NYSE: ARMP) announced positive topline results from its Phase 2 Tailwind trial of AP-PA02, an inhaled multi-phage therapeutic for treating chronic pulmonary Pseudomonas aeruginosa infections in non-cystic fibrosis bronchiectasis patients.
The trial demonstrated statistically significant reduction of P. aeruginosa in lung sputum, with effects persisting two weeks after treatment completion. A post-hoc analysis showed significant bacterial reduction at day 17 (P=0.05) and day 24 (P=0.015) compared to placebo. Approximately one-third of subjects treated with phage monotherapy showed at least a 2-log CFU reduction.
The treatment was well-tolerated with mostly mild adverse events, though one possibly related serious adverse event requiring hospitalization was reported. The study suggests AP-PA02 alone could be as effective as combination therapy with antibiotics.
Armata Pharmaceuticals (NYSE: ARMP) ha annunciato risultati positivi preliminari dal suo studio di fase 2 Tailwind su AP-PA02, un trattamento inalatorio multi-fago per la cura delle infezioni polmonari croniche da Pseudomonas aeruginosa nei pazienti con bronchiectasia non causata da fibrosi cistica.
Lo studio ha dimostrato una riduzione statisticamente significativa di P. aeruginosa nell'espettorato polmonare, con effetti che persistono due settimane dopo il completamento del trattamento. Un'analisi post-hoc ha mostrato una riduzione batterica significativa al giorno 17 (P=0.05) e al giorno 24 (P=0.015) rispetto al placebo. Circa un terzo dei soggetti trattati con monoterapia fagica ha mostrato una riduzione di almeno 2-log CFU.
Il trattamento è stato ben tollerato con principalmente eventi avversi lievi, sebbene sia stato segnalato un evento avverso serio, potenzialmente correlato, che ha richiesto il ricovero. Lo studio suggerisce che AP-PA02 da solo potrebbe essere altrettanto efficace quanto una terapia combinata con antibiotici.
Armata Pharmaceuticals (NYSE: ARMP) anunció resultados preliminares positivos de su ensayo de fase 2 Tailwind para AP-PA02, una terapia multi-fago inhalada para tratar infecciones pulmonares crónicas por Pseudomonas aeruginosa en pacientes con bronquiectasia no asociada a fibrosis quística.
El ensayo demostró una reducción estadísticamente significativa de P. aeruginosa en el esputo pulmonar, con efectos que persistieron dos semanas después de completar el tratamiento. Un análisis post-hoc mostró una reducción bacteriana significativa en el día 17 (P=0.05) y en el día 24 (P=0.015) en comparación con el placebo. Aproximadamente un tercio de los sujetos tratados con monoterapia fagica mostraron al menos una reducción de 2-log CFU.
El tratamiento fue bien tolerado, con en su mayoría eventos adversos leves, aunque se informó un evento adverso grave posiblemente relacionado que requirió hospitalización. El estudio sugiere que AP-PA02 por sí solo podría ser tan eficaz como la terapia combinada con antibióticos.
Armata Pharmaceuticals (NYSE: ARMP)는 비낭성 섬유증 기관지 확장증 환자의 만성 폐 Pseudomonas aeruginosa 감염 치료를 위한 흡입 다중 파지 치료제 AP-PA02에 대한 2상 Tailwind 시험의 긍정적인 초기 결과를 발표했습니다.
이 시험은 치료 완료 후 2주 동안 지속되는 통계적으로 유의미한 P. aeruginosa의 감소를 보여주었습니다. 사후 분석 결과, 17일째(P=0.05)와 24일째(P=0.015) 플라세보와 비교하여 유의미한 박테리아 감소가 발생했습니다. 파지 단독 요법으로 치료받은 피험자의 약 3분의 1이 최소 2-log CFU 감소를 보였습니다.
이 치료는 대부분 경미한 부작용과 함께 잘 견딜 수 있었으나, 입원이 필요한 하나의 심각한 부작용이 보고되었습니다. 이 연구는 AP-PA02가 단독으로 항생제 병용 요법만큼 효과적일 수 있음을 시사합니다.
Armata Pharmaceuticals (NYSE: ARMP) a annoncé des résultats préliminaires positifs de son essai de phase 2 Tailwind sur AP-PA02, un traitement inhalé à phages multiples pour le traitement des infections pulmonaires chroniques par Pseudomonas aeruginosa chez les patients atteints de bronchiectasie non liée à la fibrose cystique.
L'essai a démontré une réduction statistiquement significative de P. aeruginosa dans les expectorations pulmonaires, avec des effets persistant deux semaines après la fin du traitement. Une analyse post-hoc a montré une réduction bactérienne significative au jour 17 (P=0.05) et au jour 24 (P=0.015) par rapport au placebo. Environ un tiers des sujets traités par monothérapie à phages a montré une réduction d'au moins 2-log CFU.
Le traitement a été bien toléré, avec principalement des événements indésirables légers, bien qu'un événement indésirable grave, possiblement lié, ayant nécessité une hospitalisation ait été rapporté. L'étude suggère qu'AP-PA02 seul pourrait être aussi efficace qu'une thérapie combinée avec des antibiotiques.
Armata Pharmaceuticals (NYSE: ARMP) gab positive erste Ergebnisse aus seiner Phase-2-Studie Tailwind zu AP-PA02 bekannt, einer inhalativen multiphasentherapeutischen Behandlung für chronische Pseudomonas aeruginosa-Infektionen der Lunge bei Patienten mit nicht-zystischer Fibrose-Bronchiektasen.
Die Studie zeigte eine statistisch signifikante Reduktion von P. aeruginosa im Lungen-Sputum, wobei die Wirkung zwei Wochen nach Beendigung der Behandlung anhielt. Eine nachträgliche Analyse ergab eine signifikante bakterielle Reduktion am Tag 17 (P=0.05) und am Tag 24 (P=0.015) im Vergleich zur Placebo-Gruppe. Etwa ein Drittel der mit Phagen-Monotherapie behandelten Probanden zeigte eine Reduktion von mindestens 2-log CFU.
Die Behandlung wurde gut vertragen, es traten hauptsächlich milde Nebenwirkungen auf, obwohl ein möglicherweise damit zusammenhängendes schwerwiegendes unerwünschtes Ereignis, das eine Hospitalisierung erforderte, berichtet wurde. Die Studie deutet darauf hin, dass AP-PA02 allein ebenso wirksam sein könnte wie eine Kombinationstherapie mit Antibiotika.
- Statistically significant reduction in P. aeruginosa bacterial load compared to placebo
- Durable treatment effect lasting two weeks post-treatment
- One-third of monotherapy patients achieved 2-log CFU reduction vs. zero in placebo group
- Generally favorable safety and tolerability profile
- Potential to reduce reliance on chronic antibiotic use
- Individual cohort analysis showed no significant difference between treatment and placebo
- One serious adverse event reported requiring hospitalization
Insights
The Phase 2 Tailwind study results for AP-PA02 represent a significant milestone in phage therapy development. The data shows statistically significant reduction in Pseudomonas aeruginosa colony-forming units, with durability extending two weeks post-treatment (
The study's design, incorporating both monotherapy and combination therapy cohorts, provides robust insights into AP-PA02's therapeutic potential. The one-third of monotherapy patients achieving 2-log CFU reduction versus zero in placebo group indicates meaningful clinical impact. While one serious adverse event was reported, the overall safety profile appears favorable for chronic use.
For Armata Pharmaceuticals (
The positive data could attract partnership interest from larger pharmaceutical companies, particularly those with respiratory franchise portfolios. Given the mounting global concern over antibiotic resistance, AP-PA02's novel approach could command premium pricing if approved, representing significant revenue potential despite the relatively modest current market cap.
Results demonstrate that inhaled AP-PA02 provides a durable reduction of Pseudomonas aeruginosa in the lung, with a favorable safety and tolerability profile
The Tailwind study (NCT05616221) was a multicenter, randomized, double-blind, placebo-controlled trial that evaluated the safety, pharmacokinetics and efficacy of inhaled AP-PA02. The Tailwind study was conducted in two cohorts running in parallel: subjects in one cohort (cohort A) received inhaled AP-PA02 as monotherapy, while subjects in another cohort (cohort B) received inhaled AP-PA02 in combination with inhaled anti-pseudomonal antibiotic treatment. Subjects in both cohorts were dosed at home by nebulization with study drug administered every 12 hours for 10 days and were followed for approximately four weeks after receiving their last dose of study drug.
The primary efficacy endpoint was the reduction in P.a. colony forming units ("CFUs") in the lung sputum at one week following completion of dosing (day 17) compared to baseline. Per the statistical analysis plan, efficacy analysis of each independent cohort showed no significant difference between subjects treated with AP-PA02 and placebo due to small numbers of subjects in each cohort. Notably, a post-hoc intent-to-treat analysis (n=33 active and n=15 placebo; all subjects from both cohorts) demonstrated a statistically significant reduction of P.a. CFUs in the lung at day 17 (AP-PA02 vs. placebo; P=0.05). The reduction in P.a. CFUs persisted two weeks following completion of dosing with AP-PA02 when compared with placebo at day 24 (AP-PA02 vs. placebo; P=0.015). Additionally, paired analysis of P.a. CFU density at baseline compared to day 10 (P=0.03), day 11 (P=0.01), day 17 (P=0.003) and day 24 (P=0.018) was significant in the AP-PA02-treated cohort. We believe the data suggest that AP-PA02 alone is as effective as the combination therapy of phage and antibiotics in reducing P.a. CFUs in the lung. Additionally, approximately one-third of subjects treated with phage monotherapy exhibited at least a 2-log CFU reduction in P.a. compared to no reduction in placebo treated subjects. The study data indicate the potential for phage therapy to reduce reliance on chronic antibiotic use. Armata's latest corporate presentation with topline results from the Phase 2 Tailwind study can be found here.
Safety data indicate that inhaled AP-PA02 was well-tolerated with treatment-emergent adverse events mild and self-limiting. There was one possibly related serious adverse event that was linked to an acute pulmonary event requiring hospitalization that was responsive to antibiotics. We believe the safety and tolerability of AP-PA02 exhibited a promising profile for treating chronically infected NCFB patients.
"The positive results from our Tailwind study further demonstrate the potential of our high-purity phage cocktail as a new monotherapy treatment alternative for chronic pulmonary disease caused by P. aeruginosa infection, including drug-resistant bacteria," stated Dr. Deborah Birx, Chief Executive Officer of Armata. "From the beginning, our mission at Armata has been to evaluate phage-based therapeutics in randomized controlled clinical trials that evaluate safety and efficacy to support potential regulatory approval."
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 to support full commercialization.
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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