Armata Pharmaceuticals Announces the Completion of Enrollment of its Phase 1b/2a diSArm Study Evaluating Intravenous AP-SA02 as a Potential Treatment for Staphylococcus aureus Bacteremia
Armata Pharmaceuticals (NYSE American: ARMP) has completed enrollment (n=50) for its Phase 1b/2a diSArm study of intravenous AP-SA02, targeting Staphylococcus aureus bacteremia. The study aims to assess the safety, tolerability, and efficacy of AP-SA02, a bacteriophage therapy, as an adjunct to standard antibiotics. Armata expects topline data in Q1 2025, which could support the initiation of a pivotal efficacy trial later that year. Initial findings show no significant adverse events and evidence of in vivo phage amplification in half of the treated subjects. The study is backed by $21.6 million from the Defense Health Agency and the Joint Warfighter Medical Research Program.
Armata Pharmaceuticals (NYSE American: ARMP) ha completato l'arruolamento (n=50) per il suo studio di Fase 1b/2a diSArm sul AP-SA02 per via endovenosa, mirato a Staphylococcus aureus batteriemia. Lo studio si propone di valutare la sicurezza, la tollerabilità e l'efficacia di AP-SA02, una terapia a base di batteriofagi, come trattamento complementare agli antibiotici standard. Armata prevede di avere dati preliminari nel primo trimestre del 2025, che potrebbero supportare l'inizio di un trial clinico pivotale di efficacia più tardi nel corso dell'anno. I risultati iniziali non mostrano eventi avversi significativi e forniscono evidenza di amplificazione in vivo del fago nella metà dei soggetti trattati. Lo studio è finanziato con 21,6 milioni di dollari dalla Defense Health Agency e dal Joint Warfighter Medical Research Program.
Armata Pharmaceuticals (NYSE American: ARMP) ha completado la inscripción (n=50) para su estudio de Fase 1b/2a diSArm de AP-SA02 intravenoso, dirigido a bacteriemia por Staphylococcus aureus. El estudio tiene como objetivo evaluar la seguridad, la tolerabilidad y la eficacia de AP-SA02, una terapia con bacteriófagos, como complemento a los antibióticos estándar. Armata espera tener datos preliminares en el primer trimestre de 2025, lo que podría apoyar el inicio de un ensayo pivotal de eficacia más adelante ese año. Los hallazgos iniciales no muestran eventos adversos significativos y hay evidencia de amplificación de fagos in vivo en la mitad de los sujetos tratados. El estudio cuenta con el respaldo de 21.6 millones de dólares de la Defense Health Agency y del Joint Warfighter Medical Research Program.
Armata Pharmaceuticals(NYSE American: ARMP)는 황색포도상구균 혈증을 목표로 하는 정맥주사 AP-SA02의 1b/2a 단계 diSArm 연구에 대한 등록을 완료했습니다(n=50). 이 연구는 표준 항생제에 대한 보조 요법으로서의 박테리오파지 치료인 AP-SA02의 안전성, 내약성 및 효능을 평가하는 것을 목표로 합니다. Armata는 2025년 1분기에 주요 데이터가 나올 것으로 예상하며, 이는 같은 해에 중요한 효능 시험을 시작하는 데 도움이 될 수 있습니다. 초기 결과는 중대한 부작용이 없으며, 치료받은 대상자의 절반에서 박테리오파지 증폭의 in vivo 증거를 보여줍니다. 이 연구는 Defense Health Agency와 Joint Warfighter Medical Research Program으로부터 2160만 달러의 지원을 받고 있습니다.
Armata Pharmaceuticals (NYSE American: ARMP) a complété l'inscription (n=50) pour son étude de phase 1b/2a diSArm sur l'AP-SA02 intraveineux, ciblant la bactériémie à Staphylococcus aureus. L'étude vise à évaluer la sécurité, la tolérabilité et l'efficacité de l'AP-SA02, une thérapie par bactériophage, en complément des antibiotiques standards. Armata s'attend à des résultats préliminaires au premier trimestre de 2025, qui pourraient soutenir le lancement d'un essai pivotal d'efficacité plus tard dans l'année. Les premiers résultats montrent qu'il n'y a pas d'événements indésirables significatifs et des preuves d'amplification des phages in vivo chez la moitié des sujets traités. L'étude est soutenue par 21,6 millions de dollars de la Defense Health Agency et du Joint Warfighter Medical Research Program.
Armata Pharmaceuticals (NYSE American: ARMP) hat die Einschreibung (n=50) für seine Phase 1b/2a diSArm-Studie zu intravenösem AP-SA02 abgeschlossen, das auf Staphylococcus aureus-Bakteriämie abzielt. Die Studie soll die Sicherheit, Verträglichkeit und Wirksamkeit von AP-SA02, einer Bakteriophagtherapie, als Zusatz zu Standard-Antibiotika bewerten. Armata erwartet im ersten Quartal 2025 erste Ergebnisse, die den Beginn einer entscheidenden Wirksamkeitsstudie später in diesem Jahr unterstützen könnten. Erste Befunde zeigen keine signifikanten unerwünschten Ereignisse und Hinweise auf eine in vivo Phagen-Verstärkung bei der Hälfte der behandelten Probanden. Die Studie wird mit 21,6 Millionen US-Dollar von der Defense Health Agency und dem Joint Warfighter Medical Research Program unterstützt.
- Completed enrollment of 50 participants for Phase 1b/2a diSArm study.
- Topline data anticipated in Q1 2025.
- No clinically significant adverse events observed.
- Evidence of in vivo phage amplification in half of treated subjects.
- $21.6 million funding from Defense Health Agency and Joint Warfighter Medical Research Program.
- None.
Insights
This Phase 1b/2a trial completion represents a significant milestone in developing a novel bacteriophage therapy for antibiotic-resistant S. aureus infections. The study's key findings reveal encouraging safety data at higher doses (
The
For Armata Pharmaceuticals, with its
The addressable market for S. aureus bacteremia treatments is substantial, given rising antibiotic resistance rates and treatment options. A successful Phase 1b/2a outcome could attract potential partnership opportunities or additional funding for late-stage development, potentially catalyzing stock appreciation ahead of the Q1 2025 data readout.
Topline data anticipated in Q1 2025 to support potential initiation of a pivotal bacteremia efficacy trial in 2025
"The completion of enrollment of our diSArm study is a significant milestone in the development of AP-SA02, moving us one step closer to introducing an effective new treatment option to patients suffering from S. aureus bacteremia, a very serious bloodstream infection with high rates of morbidity and mortality and evolving resistance to most antibiotics," stated Dr. Deborah Birx, Chief Executive Officer of Armata. "With enrollment now complete, we are on track to report topline data in the first quarter of 2025 that, if positive, will support initiation of a pivotal bacteremia efficacy study later in the year. I am very pleased with the efficiency with which we continue to advance this important program."
During the Phase 2a portion of diSArm, Armata focused on evaluating clinical safety of higher intravenous doses of AP-SA02 and accelerating enrollment to arrive at topline data expeditiously. The manufacture of highly purified phages using Armata's proprietary methods enabled dose escalation to 5E10 PFU every six hours (2E11 PFU every 24 hours) for five days without clinically significant adverse events. In parallel with dose escalation, the evolution of two distinct blinded subsets of subjects receiving phage has been observed. One subset, comprising approximately half of the treated group, has evidence of persistence of detectable phage in the blood providing early evidence of in vivo phage amplification and resultant release of phage progeny. The Company anticipates topline data from the diSArm study in the first quarter of 2025 where it can explore the two aforementioned subsets in an unblinded manner. Topline results are also expected to inform the optimal dose of AP-SA02 to be evaluated in the larger definitive efficacy study.
"S. aureus continues to be cited by the World Health Organization and other health regulatory agencies as a high priority pathogen due to its evolving resistance to modern antibiotics and the significant socioeconomic challenges that it poses to healthcare systems," stated Mina Pastagia, MD, MS, Chief Medical Officer of Armata. "Results from diSArm will be an important step forward in our effort to confirm the potent antimicrobial activity of phage therapy. We aspire to introduce intravenous AP-SA02 as part of a new class of anti-infectives to a patient population that often faces metastatic infections with suboptimal treatment options. I would like to thank the investigators and patients who have participated in diSArm, as well as our partners at Medical Technology Enterprise Consortium (MTEC) and Naval Medical Research Command (NMRC) – Naval Advanced Medical Development (NAMD). As with all of Armata's phage clinical trials, the insights gained for local and systemic phage administration are invaluable to us and to the field as we approach pivotal trials next year."
Armata remains committed to developing a pivotal S. aureus bacteremia trial in 2025 to evaluate the intravenous phage product candidate, AP-SA02, as an adjunct to standard of care broad-spectrum antibiotics and/or potentially as an alternative to broad-spectrum antibiotics. Modern medicine requires a hard look at reliance on broad-spectrum antibiotics and their detrimental impact on the healthy human microbiome. The Company plans to discuss its pivotal trial design with the
The clinical development of AP-SA02 is supported in part by
The diSArm study is a Phase 1b/2a, 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 (BAT) compared to BAT alone for the treatment of adults with bacteremia due to S. aureus. The Phase 1b portion evaluated the safety and tolerability of multiple ascending intravenous doses of AP-SA02 or placebo as an adjunct to BAT compared to BAT alone in subjects with S. aureus bacteremia. The Phase 2a portion evaluated the efficacy, safety, and tolerability of multiple doses of intravenous AP-SA02 or placebo as an adjunct to BAT compared to BAT alone in subjects with complicated S. aureus bacteremia.
For more information: https://clinicaltrials.gov/study/NCT05184764?term=diSArm&rank=1
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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FAQ
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