Qhov Kev Tshawb Nrhiav Tshuaj Tseem Ceeb Ntawm Qhov Tshuaj Uas Tsis Dopamine D 2 Receptor Binding Drug SEP-363856 Tau Ua Tau Zoo!

Sunovion Pharma, Teb Chaws Asmeskas cov neeg pabcuam ntawm Nyiv' s Sumitomo Pharmaceuticals (Sunovion), tsis ntev los no tau tshaj tawm cov txiaj ntsig ntawm 4-lub lim tiam tseem ceeb tshawb SEP361-20 1 uas ntsuas TAAR 1 agonist SEP-363856 hauv kev kho mob ntawm tus mob schizophrenia, uas tau luam tawm hauv New England Journal of Medicine (NEJM). Cov ntawv sau npe yog: Ib Daim Ntawv Tsis-D2-Receptor-Binding Tshuaj rau Kev Kho Mob ntawm Schizophrenia.

Cov kev tshawb pom tau qhia tias SEP-363856 pawg kho mob pom tau tias muaj kev txhim kho zoo hauv tag nrho cov qhab nia ntawm Qhov Cuam Tshuam Zoo thiab Tsis Zoo (PANSS) piv nrog cov pab pawg placebo. Hauv txoj kev tshawb fawb no, qhov tshwm sim ntawm SEP-363856 pawg kho mob thiab cov pab pawg placebo rau cov tsos mob ntxiv ntawm lub cev, lub cev nyhav, thiab lwm yam kev ntsuas ntawm cov ntshav (ntshav lipid, glycated hemoglobin, prolactin, thiab lwm yam) zoo ib yam.

SEP-363856 yog TAAR 1 agonist, uas tau pom zoo ua kom muaj kev cuam tshuam cov tshuaj (BTD) rau kev kho mob schizophrenia los ntawm US FDA. Cov tshuaj muaj peev xwm dhau los ua thawj hom kev kho mob rau tus mob schizophrenia yam tsis muaj kev sib xyaw ntawm dopamine D 2 receptors. Cov tshuaj tiv thaiv kev puas hlwb.

Luam tawm hauv NEJM yog 4-lub lim tiam, xaiv ib pawg, ob lub qhov muag tsis pom kev, cov pab pawg sib tw, cov tshuaj placebo, hloov tshuaj, hloov chaw ntau qhov chaw nyob hauv cov neeg mob laus uas muaj tus mob schizophrenia, ntsuas kev ua tau zoo thiab kev nyab xeeb ntawm SEP-363856 Kev Sib Deev. Hauv txoj kev tshawb no, cov neeg mob tau tsim kho hauv 1: 1: thiab tau txais SEP-363856 (50 mg lossis 75 mg) lossis placebo ib hnub rau {{10} } lub lis piam. Lub ntsiab lus xaus yog qhov hloov ntawm tag nrho cov qhab nia ntawm Cov Muaj Tus Cwj Pwm Zoo thiab Tsis Zoo (PANSS; qib: 30 rau 210 cov ntsiab lus; cov qhab nia siab dua qhia tias cov kev mob puas siab puas ntsws ntau ntxiv nyob rau lub lim tiam 4 ntawm kev kho mob. Txoj kev tshawb no muaj 8 theem kawg, nrog rau kev hloov pauv ntawm lub hauv paus hauv Cov Chaw Kho Mob Tag Nrho Cov Kev Ntsuam Xyuas Zoo Tshaj Plaws-qhov raug ntsuas (CGI-S) thiab qhov cuam tshuam tsis zoo Cov Ntsuas Cov Lus Zoo (BNSS). Hauv txoj kev tshawb no, tag nrho ntawm 1 20 tus neeg mob tau muab rau SEP-363856 pab pawg kho mob thiab 1 25 cov neeg mob tau muab tso rau cov pawg placebo. Qhov qhab nia nruab nrab tag nrho PANSS ntawm lub hauv paus rau ob pawg yog 1 01. 4 thiab 99. 7, ntu.

Cov txiaj ntsig tau pom tias nyob rau lub lim tiam thib plaub ntawm kev kho mob, piv nrog cov pab pawg placebo, SEP-363856 ib zaug ib hnub ywj (50 - 7 5mg) pawg kho mob zoo thiab tsis pom cov tsos mob teev (PANSS) tag nrho cov qhab nia (- 1 7. 2 vs -9. 7; p=0. 001) ​​muaj cov kev txhim kho ntawm cov lus pom zoo thiab chaw kuaj mob. Piv nrog pab pawg placebo, pab pawg kho mob SEP-363856 kuj tseem qhia txog kev txhim kho hauv chaw kho mob thoob plaws qhov kev xav-mob hnyav (CGI-S) (p< 0.="" 001).="" tsis="" tas="" li="" ntawd,="" muaj="" kev="" txhim="" kho="" nyob="" rau="" hauv="" tag="" nrho="" cov="" panss="" loj="" (zoo,="" tsis="" zoo,="" thiab="" dav="" dav="" psychopathology)="" subscales="">< 0.="" 02).="" cov="" xwm="" txheej="" tsis="" zoo="" ntawm="" sep-363856="" kev="" kho="" mob="" suav="" nrog="" kev="" tsaug="" zog="" thiab="" mob="" ncauj="" plab.="" thoob="" plaws="" hauv="" txoj="" kev="" tshawb="" no,="" sep-363856="" tau="" pom="" zoo="" zoo,="" thiab="" tag="" nrho="" cov="" kev="" rho="" tawm="" ntawm="" sep-363856="" thiab="" cov="" pab="" pawg="" placebo="" tau="" sib="" piv.="" qhov="" tshwm="" sim="" ntawm="" cov="" tsos="" mob="" extrapyramidal="" thiab="" kev="" hloov="" pauv="" hauv="" cov="" ntshav="" lipid,="" glycated="" hemoglobin,="" thiab="" qib="" prolactin="" tau="" zoo="" sib="" xws="" hauv="" ob="">

John Krystal, MD, tus kws sau ntawv ntawm NEJM tsab xov xwm thiab tus thawj tswj hwm thiab tus thawj coj ntawm cov kev saib xyuas kev mob hlwb ntawm Yale Cov Chaw Tshawb Xyuas Kev Tshawb Fawb ntawm Yale University Lub Tsev Kawm Ntawv Tshuaj, hais tias:" Cov ntaub ntawv no sawv cev rau ib qib zoo siab rau tom ntej hauv kev tshawb nrhiav schizophrenia. Homphiaj TAAR 1 yog lub tswv yim tshiab ntawm kev ua rau kev kho mob schizophrenia yog sawv cev ntawm txoj kev muaj lub siab tawv thiab tsim kho tshiab rau kev kho tus mob schizophrenia. Lub sijhawm dhau los 60 xyoos, cov tshuaj tiv thaiv kev tiv thaiv kev sib xyaw ua ke nrog dopamine receptors tau ua tus qauv rau kev kho mob schizophrenia. Txawm hais tias lawv cov kev mob tshwm sim, cov kev tshawb fawb soj ntsuam tseem ceeb tso tawm lub sijhawm no txhawb txoj kev muaj peev xwm ntawm SEP-363856 yog qhov kev kho mob tshiab rau tus mob schizophrenia, uas muaj peev xwm ua rau mob schizophrenia cov neeg mob thiab lawv tsev neeg, schizophrenia Lub nra rau pej xeem kev noj qab haus huv tau muaj kev cuam tshuam zoo."

Schizophrenia (schizophrenia) yog ib tug mob ntev, mob heev, thiab feem ntau muaj kev puas hlwb uas cuam tshuam rau ntau dua 23 lab tib neeg thoob ntiaj teb. Hauv lub tebchaws United States, muaj txog 2. 4 lab tus neeg mob laus neeg mob schizophrenia, sib npaug rau ib ntawm 100 cov laus uas muaj tus mob schizophrenia. Cov kev mob tshwm sim ntawm kev mob schizophrenia muaj ntau yam, thiab nws cov yam ntxwv muaj xws li cov tsos mob zoo (xws li pom kev sib deev, tsis pom kev, tsis xav txog qhov tsis tau), cov tsos mob tsis zoo (xws li tsis muaj kev xav, kev tshem tawm ntawm zej zog, tsis muaj tshwm sim), kev paub tsis meej (cim xeeb, saib xyuas) Thiab npaj, kev ua haujlwm thiab kev txiav txim siab lub peev xwm). Kev mob schizophrenia mob heev yog cov yam ntxwv mob hlwb, suav nrog kev pom meej thiab tsis meej, thiab feem ntau yuav tsum tau pw hauv tsev kho mob. Tus kabmob yog mob ntev thiab tag lub neej, feem ntau nrog kev poob siab thiab maj mam zuj zus ntawm kev ua haujlwm thiab lub peev xwm.

SEP-363856 yog qhov tshiab txog kab mob amine-ntsig txog receptor {{2}} (TAAR 1) agonist nrog serotonin 1 A (5-HT 1 A) cov dej num agonist thiab tam sim no raug tshuaj ntsuam nyob rau hauv cov neeg mob schizophrenia. SEP-363856 tsis khi rau dopamine 2 (D 2) lossis serotonin 2 A (5-HT 2 A) cov khoom txais, uas ntseeg tias daws cov teebmeem ntawm Tam sim no muaj tshuaj atypical antipsychotic. Tam sim no, SEP-363856 tseem tab tom kawm nyob rau hauv DIAMOND theem III kev tsim kho thoob ntiaj teb rau kev kho mob schizophrenia, thiab Sumitomo Pharmaceuticals tseem tab tom txiav txim siab lwm yam kev qhia rau cov tshuaj. Hauv Tebchaws Meskas, FDA tau tso cai SEP-363856 kev tsim txom cov tshuaj muaj zog (BTD) rau kev kho tus mob schizophrenia hauv lub Tsib Hlis 2 0 1 9.

Dr. Kenneth Koblan, Tus Thawj Fwm Saib Xyuas Kev Tshawb Fawb ntawm Sunovion, tau hais tias:" Cov kev tshawb pom no tau tshaj tawm hauv New England Journal of Medicine qhia tias SEP-363856 muaj peev xwm ua tus thawj TAAR 1 agonist los kho schizophrenia. Tam sim no, muaj ntau dua 23 lab tus neeg thoob ntiaj teb Rau cov neeg mob schizophrenia, SEP-363856 raws li ib txoj hauv kev tshiab yuav muab cov kev kho mob tshiab rau cov neeg mob no. Sumitomo Kev Cog Lus tau cog lus los tsim cov kev xaiv kev kho mob tshiab rau cov neeg mob no thiab tseem kawm SEP-363856 txhawm rau tshuaj xyuas nws qhov kev kho mob tau zoo ntawm schizophrenia thiab lwm yam kab mob neuropsychiatric."

Raws li taw qhia hauv NEJM tsab xov xwm, nyob rau hauv 6-lub hlis qhib daim ntawv qhia kev kawm, SEP-363856 qhia txog kev txhim kho txuas ntxiv ntawm cov txiaj ntsig kev ua tau zoo, suav nrog tag nrho PANSS cov qhab nia, cov qhab nia ntawm CGI-S, thiab luv cov tsos mob tsis zoo teev (BNSS) tag nrho Cov Ntsiab Lus, thiab zoo li muaj kev nyab xeeb thiab thev taus.