I-Armata Pharmaceuticals, Inc., inkampani ye-biotechnology egxile ekwelapheni kwe-bacteriophage eqondene ne-pathogen yezifo ezibangelwa amagciwane futhi okunzima ukuwelapha, namuhla imemezele ukuthi i-US Food and Drug Administration (FDA) isisusile I-Armata's Investigational New Drug (IND) isicelo sokuqala isilingo somtholampilo sekhandidethi laso lezokwelapha elithuthukisiwe, i-AP-PA02, kunkomba yesibili, i-non-cystic fibrosis bronchiectasis (NCFB). Inkampani ihlela ukuqala isivivinyo seSigaba 2 ngo-2022.
Ezigulini ezine-NCFB, ukutheleleka kwamaphaphu nge-Pseudomonas aeruginosa kuvame ukuhlotshaniswa nokwanda kwamaphaphu kaningi, izinga lokuphila elincishisiwe, nokufa kwabantu okwandisiwe, futhi kungase kudinge ukulaliswa esibhedlela ukuze bathole ukwelashwa. Nakuba ama-antibiotic ehogeliwe angalapheki atuswa ekuphathweni kwesikhathi eside kwe-NCFB ngokukhula okuvamile, okwamanje akukho ukwelashwa okugunyaziwe.
"Sijabule ngokuthola imvume ye-FDA yokuthuthukisa i-AP-PA02 ibe uphawu lwesibili lokuphefumula," kusho uBrian Varnum, oyiChief Executive Officer ye-Armata. "Ngale mvume yokulawula kanye noxhaso lwethu lwezimali lwakamuva, sisesimweni esihle sokuhlola inzuzo yomtholampilo ye-AP-PA02, kanye nokuqhubekisela phambili i-AP-SA02 yezifo ezihlangene zokwenziwa kanye ne-AP-PA03 yenyumoniya."
Ngokungeziwe ocwaningweni oluzayo lwe-AP-PA02 ku-NCFB, u-Armata uphinda enze uhlolo lweSigaba 1b/2a ('SWARM-Pa') se-AP-PA02 eqondise ukutheleleka kwe-Pseudomonas aeruginosa ezigulini ze-cystic fibrosis, kanye nesivivinyo seSigaba 1b/2a. ('diSArm') ye-AP-SA02 eqondise i-Staphylococcus aureus bacteremia.
LOKHO ONGAKUTHATHE KULESI SIHLOKO:
- Ngokungeziwe esivivinyweni esizayo se-AP-PA02 ku-NCFB, u-Armata uphinda enze uhlolo lweSigaba 1b/2a ('SWARM-P.
- I-Food and Drug Administration (i-FDA) isule isicelo se-Armata's Investigational New Drug (IND) ukuze iqalise ukuhlolwa komtholampilo kwekhandidethi layo lezokwelapha elithuthukisiwe, i-AP-PA02, kunkomba yesibili, i-non-cystic fibrosis bronchiectasis (NCFB).
- “Ngale mvume yokulawula kanye noxhaso lwethu lwezimali lwakamuva, sisesimweni esihle sokuhlola inzuzo yomtholampilo ye-AP-PA02, kanye nokuqhubekisela phambili i-AP-SA02 yezifo ezihlangene zokwenziwa kanye ne-AP-PA03 yenyumoniya.