Armata Pharmaceuticals, Inc., kambani yebiotechnology yakatarisa pathogen-yakananga bacteriophage therapeutics yemishonga inorwisa mabhakitiriya uye yakaoma-kurapa utachiona, nhasi yakazivisa kuti US Food and Drug Administration (FDA) yakabvisa Armata's Investigational New Drug (IND) Chikumbiro chekutanga kuyedza kwekiriniki yeakagadziridzwa anotungamira therapeutic mumiriri, AP-PA02, mune yechipiri chiratidzo, isiri-cystic fibrosis bronchiectasis (NCFB). Iyo kambani inoronga kutanga Phase 2 muyedzo muna 2022.
Muvarwere vane NCFB, chirwere chemapapu chePseudomonas aeruginosa chinowanzobatanidzwa nekuwedzerwa kwemapapu, kuderedzwa kwehupenyu, uye kuwedzera kwekufa, uye zvingada kubvumirwa kuchipatara kurapwa. Kunyange zvazvo chisingaperi chinofemerwa mishonga inorwisa mabhakitiriya ichikurudzirwa kutonga kwenguva refu kweNCFB nekuwedzeredza nguva zhinji, parizvino hapana marapirwo anotenderwa.
"Tinofara kuwana mvumo yeFDA yekusimudzira AP-PA02 mune yechipiri chiratidzo chekufema," akadaro Brian Varnum, Chief Executive Officer weArmata. "Nemvumo iyi yemutemo uye nerubatsiro rwemari yatichangoburwa, takamisikidzwa kuti tiongorore rubatsiro rwekiriniki rweAP-PA02, uye kusimudzira AP-SA02 yezvirwere zvemajoini uye AP-PA03 yemabayo."
Pamusoro pekuyedzwa kuri kuuya kweAP-PA02 muNCFB, Armata iri kuitawo Phase 1b/2a kuyedza ('SWARM-Pa') yeAP-PA02 yakanangana nePseudomonas aeruginosa kutapukira mu cystic fibrosis varwere, uye Phase 1b/2a muyedzo. ('diSArm') yeAP-SA02 yakanangana neStaphylococcus aureus bacteremia.
ZVOKUBVA MUNYAYA INO:
- Pamusoro pekuyedzwa kuri kuuya kweAP-PA02 muNCFB, Armata iri kuitawo Phase 1b/2a muyedzo ('SWARM-P.
- Food and Drug Administration (FDA) yakabvisa Armata's Investigational New Drug application (IND) kuti itange kuyedza yekiriniki yeakagadziridzwa anotungamira therapeutic candidate, AP-PA02, muchiratidzo chechipiri, non-cystic fibrosis bronchiectasis (NCFB).
- "Nemvumo iyi yemutemo uye nemari yatichangoburwa, takamisikidzwa kuti tiongorore rubatsiro rwekiriniki rweAP-PA02, uye kufambisira mberi AP-SA02 yezvirwere zvakabatana zvenhengo uye AP-PA03 yemabayo.
