Phase 3 kev kho mob ua tiav ntawm qhov tshiab-ua yeeb yam proton twj tso kua mis inhibitor vonoprasan!--1/2

Phatom Pharmaceuticals tau tsim nyob rau xyoo 2018 thiab koom tes tsim los ntawm Takeda, mob siab rau kev txhim kho thiab kev lag luam ntawm cov kev kho tshiab tshiab rau kev kho mob plab hnyuv. Tsis ntev los no, lub tuam txhab tshaj tawm tiasvonoprasantau ua tiav qhov kawg ntawm thawj qhov kawg thiab qhov tseem ceeb thib ob qhov txiaj ntsig kawg ntawm qhov tseem ceeb Theem 3 PHALCON-EE mus sib hais. Kev sim yog ntsuas qhov ua tau zoo thiab kev nyab xeeb ntawm vonoprazan txheeb ze rau lansoprazole hauv kev kho mob erosive esophagitis (EE).

Raws li cov ntaub ntawv zoo ntawm PHALCON-EE test, Phatom npaj yuav xa daim ntawv thov tshuaj tshiab (NDA) rauvonoprasanmus rau US FDA rau kev kho mob ntawm cov lus qhia hauv qab no: kho txhua theem ntawm EE thiab txo qhov kub siab, tswj kev kho mob ntawm txhua theem ntawm EE thiab txo lub plab Scorching.

Vonoprazan yog lub qhov ncauj me me molecule potassium ion (K+) kev sib tw acid blocker (P-CAB) tsim los ntawm Takeda. Phathom tau tso cai rau kev txhim kho tshwj xeeb ntawm cov tshuaj hauv Tebchaws Meskas, Europe thiab Canada. txoj cai. P-CAB yog ib hom tshuaj tshiab uas tuaj yeem thaiv cov kua qaub hauv plab. Raws li cov lus ceeb toom, vonoprasan tuaj yeem tso tseg cov kua qaub hauv plab thaum ntxov los ntawm inhibiting qhov khi ntawm K+ rau H / K-ATPase (proton twj tso kua mis) hauv cov kauj ruam kawg ntawm gastric acid secretion hauv parietal hlwb. VimvonoprasanNws muaj qhov ntev ib nrab-lub neej thiab lub sijhawm ntev ntawm kev ua haujlwm, nws raug suav tias yog qhov ua tau zoo ntev-ua haujlwm proton twj tso kua mis inhibitor (PPI).

Raws li kev kho mob monotherapy rau kev kho mob gastroesophageal reflux kab mob (GERD) thiab ua ke nrog cov tshuaj tua kab mob rau kev kho mob Helicobacter pylori (H.pylori) kab mob, vonoprasan tau qhia sai, muaj zog thiab ntev-ntev antisecretory cov teebmeem. Yav dhau los, FDA tau tso cai Fast Track Qualification (FTD) rau kev kho tus kab mob Helicobacter pylori nrog vonoprasan ua ke nrog amoxicillin thiab clindamycin, thiabvonoprasanua ke nrog amoxicillin. Thaum lub Cuaj Hlis 2021, Phathom tau xa Daim Ntawv Thov Tshuaj Tshiab (NDA) rau US FDA kom siv ob qho saum toj no cov tshuaj vonoprasan rau kev kho tus kab mob Helicobacter pylori.

Terrie Curran, Thawj Tswj Hwm thiab CEO ntawm Phatom, tau hais tias:" Cov txiaj ntsig ntawm Phatom-EE txoj kev tshawb fawb yog qhov tseem ceeb tshaj plaws rau Phatom thiab 20 lab Asmeskas cov neeg mob uas muaj erosive esophagitis. Qhov txiaj ntsig no ntxiv dag zog rau vonoprasan ua lag luam GERD hauv Asmeskas thiab Europe rau ntau tshaj 30 xyoo. Qhov no yog thawj qhov tseem ceeb ntawm kev tsim kho tshiab. Cov txiaj ntsig tau pom tias hauv txoj kev tshawb no, vonoprasan yog qhov zoo tshaj rau kev saib xyuas tus qauv PPI hauv ntau qhov chaw kho mob cuam tshuam txog qhov kawg, thiab qhov tseem ceeb, suav nrog kev saib xyuas kev kho kom zoo nyob rau hauv 24 lub lis piam ntawm kev kho mob hauv txhua tus neeg mob EE. vonoprasan Nws muaj peev xwm ua tau raws li qhov xav tau kev kho mob ntau yam tsis tau ntsib hauv ntau tus neeg mob, thiab muaj peev xwm los teeb tsa kev kho mob tshiab rau EE."

Vonoprazan chemical qauv

Kev xeem PHALCON-EE tau muab faib ua 2 theem. Hauv thawj theem, tom qab txog li 8 lub lis piam ntawm kev kho mob, sib piv cov txiaj ntsig ntawmvonoprasan20mg thiab lansoprazole 30mg ntawm EE kho (lub sijhawm kho). Hauv lub sijhawm kho, tus neeg mob tau lees paub tias yuav kho tau zoo los ntawm kev kuaj ntshav tom qab 2 lub lis piam ntawm kev kho mob. Yog tias kev kho tsis tiav, qhov thib ob endoscopy yog ua tiav ntawm 8 lub lis piam ntawm kev kho mob.