Tebipenem HBr Ua Daim Ntawv Teev Npe: Kev Kho Mob Ntawm Cov Kab Mob Ntshav Qab Zib (cUTI)

Spero Therapeutics tau cog lus rau kev txhim kho thiab kev lag luam ntawm cov tshuaj los kho ntau hom tshuaj tiv thaiv kab mob (MDR) kab mob thiab kab mob tsawg. Tsis ntev los no, lub tuam txhab tshaj tawm tias nws tau xa Daim Ntawv Thov Tshuaj Tshiab (NDA) rau qhov ncauj tshuaj tua kab mob tebipenem HBr ntsiav tshuaj (yav tas los hu ua SPR994) mus rau US Food and Drug Administration (FDA): rau kev kho mob ntawm cov kab mob urinary complex tshwm sim los ntawm kev raug mob. microorganisms (CUTI, suav nrog pyelonephritis). Yog tias pom zoo, tebipenem HBr yuav dhau los ua cov tshuaj tua kab mob carbapenem nkaus xwb uas tuaj yeem siv los kho cUTI, uas yuav hloov pauv kev kho mob.

Qhov kev xa tawm NDA yog raws li cov ntaub ntawv zoo ntawm Theem 3 ADAPT-PO sim sib tham yav dhau los. Cov txiaj ntsig tau pom tias txoj kev tshawb fawb tau mus txog qhov kawg ntawm qhov kawg: hauv kev kho mob ntawm cUTI thiab mob pyelonephritis (AP), qhov ua tau zoo ntawm qhov ncauj tebipenem HBr yog qhov txheeb xyuas tsis zoo rau cov hlab ntsha (IV) ertapenem (ertapenem).

Cov qauv tshuaj ntawm Tippenem Pivoxil (daim duab qhov chaw: medchemexpress.com)

Tebipenem HBr yog ib qho kev npaj qhov ncauj tshiab ntawm tebipenem pivoxil. Tippenem ester yog β-lactam carbapenem tshuaj tua kab mob. Nws tau ua lag luam hauv Nyij Pooj los ntawm Meiji Pharmaceutical Co., Ltd. (Meiji) txij li xyoo 2009 (hom npe Orapenem) rau kev kho mob ntawm cov mob ntsws, Otitis media, cov menyuam yaus ntawm sinusitis. Cov tshuaj tua kab mob Carbapenem yog ib qho tseem ceeb ntawm cov tshuaj tua kab mob vim tias lawv muaj kev nyab xeeb thiab siv tau zoo hauv kev kho cov kab mob Gram-negative resistant.

tebipenem HBr yog tsim los kho cUTI thiab mob pyelonephritis (AP). Yav dhau los, US FDA tau tso cai tebipenem HBr cov khoom tsim nyog kis kab mob (QIDP) thiab kev tsim nyog taug qab nrawm (FTD) rau kev kho mob ntawm cUTI thiab AP. Yog tias pom zoo, tebipenem HBr yuav dhau los ua thawj qhov ncauj carbapenem tshuaj tua kab mob los ua lag luam hauv Tebchaws Meskas.

Ankit Mahadevia, MD, Tus Thawj Coj Tus Thawj Coj ntawm Spero Therapeutics, tau hais tias:" Nrog rau kev xa tawm ntawm NDA, peb tau ua ib kauj ruam tseem ceeb rau peb lub hom phiaj ntawm kev muab kev kho qhov ncauj rau feem ntau ntawm cov neeg mob cUTI. Qhov kev kho qhov ncauj no tuaj yeem hloov qhov kev siv mus sij hawm ntev Intravenous (IV) therapy. Yog tias pom zoo, peb ntseeg tias tebipenem HBr tuaj yeem pab cov neeg mob thiab zam kev txo qis ntawm kev siv cov peev txheej kho mob uas yuav tshwm sim los ntawm kev txhaj tshuaj IV. Peb tos ntsoov yuav ua haujlwm nrog FDA thaum lub sijhawm NDA tshuaj xyuas txheej txheem thiab muab tebipenem HBr hauv 2022 Kev Npaj rau cov npe uas xav tau hauv rau lub hlis."

ADAPT-PO cov ntaub ntawv tshawb fawb soj ntsuam

ADAPT-PO yog randomized placebo-tswj theem 3 kev soj ntsuam kuaj mob hauv tsev kho mob cov neeg laus nrog cUTI lossis AP los ntsuas qhov ua tau zoo thiab kev nyab xeeb ntawm tebipenem HBr. Hauv qhov kev sim no, cov neeg mob tau muab faib ua pawg ntawm qhov sib piv ntawm 1: 1. Ib pawg tau txais tebipenem HBr (600 mg ntawm qhov ncauj, ib zaug txhua 8 teev), thiab lwm pab pawg tau txais ertapenem (1 g, intravenous infusion, ib zaug txhua 24 teev). ), tag nrho ntawm 7-10 hnub ntawm kev kho mob. Cov neeg mob bacteremia tau txais kev kho mob ntev txog 14 hnub. Lub ntsiab lus kawg ntawm txoj kev tshawb no yog: tag nrho cov lus teb tus nqi (ORR) thaum lub sij hawm ntawm kev ntsuam xyuas kev kho (TOC) mus ntsib (hnub 19 ± 2) nyob rau hauv cov micro-ITT cov pej xeem, txhais raws li kev kho mob + pathogenic microorganisms tshem tawm.

Cov txiaj ntsig tau pom tias txoj kev tshawb fawb tau mus txog qhov kawg ntawm qhov kawg: hauv TOC mus ntsib cov neeg nyob hauv micro-ITT, qhov ncauj tebipenem HBr tsis yog qis dua IV ertapenem hauv ORR. Cov ntaub ntawv tshwj xeeb yog: ORR ntawm pawg tebipenem HBr kev kho mob yog 58.8% (264/449), thiab ORR ntawm pawg ertapenem yog 61.6% (258/419) (kev kho qhov sib txawv: -3.3%; 95% CI: - 9.7, 3.2; non-Inferiority [NI] txiav tawm tus nqi yog -12.5%). ORR tau zoo ib yam ntawm cov pab pawg tseem ceeb (xws li hnub nyoog, kev kuaj mob hauv paus, thiab muaj cov kab mob bacteremia). Rau cov kab mob urinary ntau tshaj plaws, cov lus teb ntawm txhua pab pawg kho mob rau txhua tus kab mob pathogenic tau sib npaug.

Tsis tas li ntawd, txoj kev tshawb fawb kuj tau mus txog qhov tseem ceeb thib ob qhov kawg: qhov kev kho mob ntawm TOC mus ntsib hauv ob pawg tau siab dua (> 93%), 93.1% hauv qhov ncauj tebipenem HBr pawg, thiab 93.6% hauv pawg IV ertapenem. . Hauv qhov kev tshawb fawb no, tebipenem HBr tau txais txiaj ntsig zoo thiab nws cov ntaub ntawv kev nyab xeeb zoo ib yam li IV ertapenem.