Brexafemme launched hauv Tebchaws Meskas: kev kho mob ntawm vulvovaginal candidiasis (VVC)--2/2

Tam sim no, kev kho mob ntawm VVC suav nrog ntau cov tshuaj azole antifungals (clotrimazole, miconazole, thiab lwm yam) thiab fluconazole. Cov tom kawg yog tam sim no tsuas yog qhov ncauj tshuaj tiv thaiv kab mob pom zoo rau kev kho mob ntawm VVC hauv Tebchaws Meskas. Fluconazole tau tshaj tawm txog 55% kev kho mob tus nqi ntawm nws daim ntawv lo, thiab tam sim no kuj suav nrog kev ceeb toom ntawm qhov muaj feem cuam tshuam rau tus menyuam hauv plab, qhia txog qhov xav tau kev hloov qhov ncauj tshiab. Qhov ncauj fluconazole lossis tshuaj pleev tsis tuaj yeem ua tau raws li qhov xav tau ntawm cov poj niam cov neeg mob uas muaj qhov nruab nrab mus rau qhov hnyav VVC, rov ua VVC, anti-fluconazole-induced VVC, thiab VVC ntawm lub hnub nyoog yug menyuam. Tsis tas li ntawd, rau cov neeg mob VVC uas tsis teb lossis ua tsis taus rau kev kho mob fluconazole, tsis muaj lwm txoj hauv kev, thiab tsis muaj FDA pom zoo cov khoom los tiv thaiv VVC rov tshwm sim.

Cov khoom xyaw tshuaj nquag ntawm Brexafemme yogibrexafungerp, uas yog ib qho tshiab, dav-spectrum antifungal tshuaj thiab thawj tus neeg sawv cev ntawm triterpenoids, glucan synthase inhibitor nrog cov qauv tshwj xeeb. ibrexafungerp ua ke cov kev ua haujlwm zoo ntawm glucan synthase inhibitors nrog lub peev xwm ua tau yooj yim ntawm kev tswj qhov ncauj thiab cov hlab ntsha. Tam sim no, cov tshuaj tau tsim los kho cov kab mob fungal tshwm sim los ntawm Candida (xws li Candida auris, C.auris) thiab Aspergillus. Hauv kev tshawb fawb hauv vitro thiab hauv vivo, cov tshuaj tau pom dav-spectrum antifungal kev ua haujlwm tawm tsam ntau yam tshuaj tiv thaiv kab mob (xws li cov kab mob tiv taus azole thiab echinocandin). Yav dhau los, US FDA tau tso caiibrexafungerpKev npaj ntawm qhov ncauj thiab cov hlab ntsha los kho vulvovaginal candidiasis (VVC), invasive candidiasis (IC, nrog rau candidiasis), thiab invasive aspergillosis (IA) raws li cov khoom tsim nyog kis kab mob (QIDP) thiab Fast Track Qualification (FTD), thiab tau txais Orphan Drug Qualification (ODD. ) rau kev kho mob ntawm IC thiab IA indications.

VANISH cov ntaub ntawv kho mob qhov ua tau zoo

FDA pom zoo Brexafemme raws li cov ntaub ntawv los ntawm VANISH Phase 3 qhov chaw kho mob. Qhov project suav nrog 2 qhov kev sib tw, cov placebo-tswj theem 3 kev tshawb fawb soj ntsuam, uas yog VANISH 303 (NCT03734991) thiab VANISH 306 (NCT03987620). Ob txoj kev tshawb fawb no tau txais kev tsim qauv zoo sib xws los ntsuas qhov ua tau zoo thiab kev nyab xeeb ntawm Brexafemme 600mg ib hnub noj tshuaj noj (2 koob tshuaj, 300mg txhua [2 ntsiav tshuaj 150mg], 12 teev sib nrug) hauv kev kho mob vulvovaginal candidiasis (VVC). Kev mus saib xyuas suav nrog kev kho mob (TOC, hnub 8-14) mus ntsib thiab rov qab mus ntsib (FU, hnub 21-29). Cov neeg kho mob hloov kho (MITT) suav nrog cov neeg mob uas muaj kab lis kev cai Candida zoo ntawm qhov pib thiab tau noj tsawg kawg ib koob ntawm cov tshuaj tshawb fawb.

Lub ntsiab lus kawg yog qhov kev kho mob ntawm TOC mus ntsib hnub 10. Cov kev kho mob tau txhais tias yog kev ploj tag nrho ntawm qhov chaw mos thiab cov tsos mob (tag nrho S& S qhab nia yog 0); Cov ntsiab lus tseem ceeb thib ob suav nrog kev ua tiav ntawm kev tshem tawm cov kab mob fungal ntawm TOC mus ntsib (cov kab lis kev cai tsis zoo) ), kev txhim kho kev kho mob tau ua tiav ntawm TOC mus ntsib (S& S tag nrho cov qhab nia yog 0 lossis 1), thiab cov tsos mob ploj tag ntawm FU mus ntsib hnub tim 25. Cov tsos mob thiab cov tsos mob (S& S) cov qhab nia yog txhais raws li qhov kawg ntawm cov tsos mob (hlawv, khaus, khaus) qhia los ntawm cov neeg kawm thiab cov cim qhia (o, liab, khawb) soj ntsuam los ntawm tus neeg tshawb xyuas. Txhua qhov cim thiab cov tsos mob tuaj yeem muab faib ua tsis muaj, me, nruab nrab, thiab hnyav. Cov qhab nia sib thooj yog 0 txog 3 cov ntsiab lus, thiab tag nrho cov qhab nia sib xyaw yog 0 txog 18 cov ntsiab lus.

Cov txiaj ntsig tau los ntawm ob txoj kev tshawb fawb pom tau tias: Piv nrog cov placebo, Brexafemme muaj cov txiaj ntsig zoo ntawm cov txiaj ntsig ntawm cov ntsiab lus tseem ceeb ntawm cov ntsiab lus tseem ceeb thiab cov ntsiab lus tseem ceeb thib ob, thiab nws muaj kev nyab xeeb thiab zam tau zoo.

—— Cov txiaj ntsig ntawm kev ua tau zoo ntawm txoj kev tshawb fawb VANISH-306: Hnub 10 ntawm TOC mus ntsib, 63.3% ntawm pab pawg kho mob Brexafemme tau txais kev kho mob (44.0% hauv pawg placebo, p< 0.01),="" thiab="" 58.5="" %="" ntawm="" cov="" neeg="" mob="" ua="" tiav="" cov="" kab="" mob="" fungal="" (29.8%="" hauv="" pawg="" placebo,="">< 0.001),="" thiab="" 72.3%="" ntawm="" cov="" neeg="" mob="" ua="" tiav="" kev="" kho="" mob="" (54.8%="" hauv="" pawg="" placebo,="" p="0.01);" ntawm="" 25="" hnub="" fu="" mus="" ntsib,="" 73.9%="" ntawm="" cov="" neeg="" mob="" hauv="" pab="" pawg="" kho="" mob="" brexafemme="" tau="" ua="" tiav="" cov="" tsos="" mob="" ploj="" tag="" (52.4%="" hauv="" pawg="" placebo,="" p="">

—— Cov txiaj ntsig ntawm kev ua tau zoo ntawm VANISH-303 txoj kev tshawb fawb: Ntawm TOC mus ntsib hnub 10, 50.5% ntawm pab pawg kho mob Brexafemme tau txais kev kho mob (28.6% hauv pawg placebo, p=0.001), thiab 49.5% ntawm cov neeg mob. ua tiav cov kab mob fungal (Cov pab pawg placebo yog 19.4%, p< 0.001),="" thiab="" 64.4%="" ntawm="" cov="" neeg="" mob="" ua="" tiav="" kev="" kho="" mob="" (cov="" placebo="" pab="" pawg="" yog="" 36.7%,="">< 0.001);="" ntawm="" 25="" hnub="" fu="" mus="" ntsib,="" 59.6%="" ntawm="" pab="" pawg="" kho="" mob="" brexafemme="" tau="" ua="" tiav="" kev="" kho="" mob="" cov="" tsos="" mob="" ploj="" tag="" (44.9%="" hauv="" pawg="" placebo,=""><>