Armata Pharmaceuticals, Inc. operates as a clinical-stage biotechnology company, which focuses on the development of bacteriophage therapeutics for the treatment of drug-resistant bacterial infections. The company was founded in 1989 and is headquartered in Los Angeles, CA.
相关临床试验
13
0 进行中
药物批准
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监管机构
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监管机构数
成立时间
2005
已完成
11
84.6%
No Longer Available
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15.4%
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- The FDA granted Breakthrough Therapy designation to AP-SA02, Armata Pharmaceuticals' intravenous multi-phage candidate, for adjunct treatment of complicated Staphylococcus aureus bacteremia including MSSA and MRSA. - The designation was supported by Phase 1b/2a diSArm data showing 100% of AP-SA02-treated patients maintained clinical response without relapse at 28 days versus 75% with placebo. - AP-SA02 was dosed intravenously every six hours for five days alongside best available antibiotic therapy, with no serious adverse events attributed to the drug. - Armata plans to initiate a Phase 3 superiority study in complicated S. aureus bacteremia in the second half of 2026, supported in part by a $28.7 million Department of War award.
- Armata Pharmaceuticals announced a Journal of Molecular Biology paper presenting an integrative structural atlas of Ar-KM, a phiKMV-like bacteriophage targeting Pseudomonas aeruginosa. - Using cryo-electron microscopy, proteomics and bioinformatics, researchers captured three distinct phage particle states and built atomic models for eleven structural proteins at near-atomic resolution. - The work identifies an enzyme activity aiding bacterial cell envelope penetration and a previously unrecognized protein enabling coordinated genome release and delivery. - Armata said it is now extending cryo-EM reconstruction to its proprietary Staphylococcus aureus phages, following four publications characterizing its Pseudomonas phages.
- Armata Pharmaceuticals has formally commissioned its 56,000 square foot cGMP manufacturing facility in Los Angeles, marking a key milestone for advancing bacteriophage therapeutics against antibiotic-resistant infections. - The facility includes 10,000 square feet of cGMP clean rooms and automated fill-and-finish capabilities, enabling domestic production of high-purity, multi-phage cocktails for clinical trials and future commercial use. - The company plans to advance its AP-SA02 candidate into a potential pivotal Phase 3 trial in 2026, subject to FDA review and feedback. - CEO Dr. Deborah Birx emphasized the facility's role in reducing reliance on antibiotics and addressing the antimicrobial resistance crisis through onshore manufacturing capabilities.
- Armata Pharmaceuticals' Phase 1b/2a diSArm trial demonstrated that AP-SA02, a novel intravenous bacteriophage therapy, met all primary endpoints for safety, tolerability, and clinical response in complicated Staphylococcus aureus bacteremia. - The bacteriophage therapy significantly improved clinical outcomes compared to best available antibiotic therapy alone, with 100% of AP-SA02-treated patients responding at end of study versus 75% in the placebo group (p=0.020). - AP-SA02 was well-tolerated with no serious adverse events related to the study drug, showing efficacy against both methicillin-sensitive and methicillin-resistant S. aureus infections, marking a breakthrough in phage therapy for systemic bacterial infections.
- The Non-Cystic Fibrosis Bronchiectasis (NCFB) market is projected to grow from USD 1.7 billion in 2024 to USD 7.5 billion by 2035, representing a robust CAGR of 14.62%. - Advancements in diagnostic technologies, including high-resolution computed tomography, molecular tests, and AI-based imaging, are significantly improving early detection and treatment planning for NCFB patients. - Several promising therapies are in late-stage development, including Insmed's brensocatib, which recently had its NDA accepted by the FDA after showing significant reduction in pulmonary exacerbations in Phase 3 trials.
• Armata Pharmaceuticals' AP-PA02, a therapeutic phage cocktail, is currently in Phase II trials for bronchiectasis and pseudomonal infections, targeting *P. aeruginosa* in respiratory infections. • BiomX's BX004, a phage therapy, is in Phase I/II trials for chronic *Pseudomonas aeruginosa* pulmonary infections in cystic fibrosis patients, demonstrating activity against antibiotic-resistant strains. • The pipeline for chronic *Pseudomonas aeruginosa* pulmonary infections includes over 12 drugs in various stages of clinical development, with companies like Gilead and Respirion also involved.
• The non-cystic fibrosis bronchiectasis (NCFB) market is experiencing growth due to rising prevalence and increased awareness, leading to early diagnosis and treatment. • Over 15 companies are actively developing more than 15 NCFB drugs, aiming to improve the treatment landscape for this chronic lung condition. • Key players like Insmed, AstraZeneca, and Verona Pharma are advancing promising therapies such as brensocatib, benralizumab and ensifentrine through clinical trials. • Recent clinical trial milestones, including Phase III results for brensocatib and Phase II enrollment for AP-PA02, signal progress in addressing unmet needs in NCFB treatment.
- Iovance Biotherapeutics' MDA-TIL Phase II trial was terminated due to lack of efficacy, significantly decreasing its Phase Transition Success Rate (PTSR) in ovarian, colorectal, and pancreatic cancers. - Sention Therapeutics' ST-1891 Phase II trial in hypothyroidism was completed, leading to a nine-point increase in the drug's PTSR, reaching 22% for this indication. - Karyopharm Therapeutics' Xpovio (selinexor) Phase II trial in metastatic melanoma was terminated due to insufficient anti-tumor activity, resulting in a 14-point PTSR decrease to 11%. - Armata Pharmaceuticals' APPA-02 Phase II trial in bronchiectasis was completed, increasing the drug candidate’s PTSR by seven points to 43%.
