Armata Pharmaceuticals, Inc., perusahaan bioteknologi fokus ing terapi bakteriofag spesifik patogen kanggo infeksi bakteri sing tahan antibiotik lan angel diobati, dina iki ngumumake yen US Food and Drug Administration (FDA) wis ngresiki Armata's Investigational New Drug (IND) aplikasi kanggo miwiti uji klinis saka calon terapeutik timbal sing dioptimalake, AP-PA02, ing indikasi kapindho, non-cystic fibrosis bronchiectasis (NCFB). Perusahaan kasebut ngrancang kanggo miwiti uji coba Tahap 2 ing 2022.

Ing pasien karo NCFB, infèksi paru-paru karo Pseudomonas aeruginosa asring digandhengake karo exacerbations paru sing kerep, kualitas urip sing suda, lan tambah kematian, lan bisa uga mbutuhake rumah sakit kanggo perawatan. Senajan antibiotik inhalasi kronis dianjurake kanggo manajemen jangka panjang NCFB kanthi exacerbations sing kerep, saiki ora ana terapi sing disetujoni.

"Kita seneng entuk izin FDA kanggo maju AP-PA02 dadi indikasi ambegan kapindho," ujare Brian Varnum, Kepala Eksekutif Armata. "Kanthi persetujuan peraturan iki lan pendanaan anyar kita, kita duwe posisi sing apik kanggo njelajah keuntungan klinis AP-PA02, lan maju AP-SA02 kanggo infeksi sendi prostetik lan AP-PA03 kanggo radhang paru-paru."

Saliyane uji coba AP-PA02 sing bakal teka ing NCFB, Armata uga nganakake uji coba Tahap 1b/2a ('SWARM-Pa') AP-PA02 sing target infeksi Pseudomonas aeruginosa ing pasien fibrosis kistik, lan uji coba Tahap 1b/2a. ('diSArm') saka AP-SA02 nargetake Staphylococcus aureus bacteremia.

APA sing kudu dijupuk saka ARTIKEL INI:

In addition to the upcoming trial of AP-PA02 in NCFB, Armata is also conducting a Phase 1b/2a trial (‘SWARM-P.
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).
“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.