Axsome's tshiab qhov ncauj multi-mechanism tshuaj AXS-07 nkag mus tshuaj xyuas hauv Tebchaws Meskas--1/2

Axsome Therapeutics yog lub tuam txhab biopharmaceutical mob siab rau kev tsim kho tshiab los kho cov kab mob hauv nruab nrab paj hlwb (CNS). Tsis ntev los no, lub tuam txhab tshaj tawm tias US Food and Drug Administration (FDA) tau lees txais daim ntawv thov tshuaj tshiab (NDA) rau cov tshuaj tshiab ntawm qhov ncauj ntau yam tshuaj AXS-07 (MoSEIC).meloxicam/rizatriptan ua, 20mg / 10mg) rau kev kho mob migraine. Lub NDA's" Kev Tshuaj Xyuas Tus Neeg Siv Tshuaj Txhaum Cai" (PDUFA) lub hom phiaj hnub tim yog lub Plaub Hlis 30, 2022. Cov ntaub ntawv kho mob qhia tau hais tias AXS-07 kev kho mob tuaj yeem kho tau sai, zoo thiab kav ntev kom txo tau cov mob migraine thiab lwm yam tsos mob, thiab muaj kev nyab xeeb zoo thiab ua kom ntev.

AXS-07 (MoSEIC meloxicam / rizatriptan, 20mg / 10mg) yog ib hom tshuaj tshiab ntawm qhov ncauj nrog lub zog tshwj xeeb ntawm kev ua haujlwm. Nws yog tam sim no nyob rau hauv kev kho mob rau kev kho mob ntawm migraine. AXS-07 yog tsim los ntawm MoSEIC meloxicam thiab rizatriptan. Meloxicam yog ib qho chaw tshiab molecular uas siv Axsome's MoSEIC (Molecular Solubility Enhancement Inclusion Complex) thev naus laus zis kom ua tiav kev kho mob migraine. Cov thev naus laus zis no tso cai rau kev nqus sai ntawm meloxicam thaum tuav lub plasma ntev ib nrab-lub neej.meloxicamyog COX-2 biased non-steroidal anti-inflammatory tshuaj, thiabrizatriptan uayog 5-HT1B/1D agonist. AXS-07 yog tsim los muab kev ceev, txhim khu kev qha thiab txhawb nqa migraine nyem thiab txo qhov rov tshwm sim ntawm cov tsos mob.

AXS-07 NDA yog raws li cov txiaj ntsig ntawm 2 theem 3 randomized, ob-dig muag, tswj kev sim (MOMENTUM, INTERCEPT) rau kev kho mob mob migraine. Hauv kev tshawb fawb MOMENTUM, cov neeg mob uas muaj keeb kwm tsis txaus rau kev kho mob tau sau npe, thiab kev kho mob tau txais sai li sai tau thaum muaj mob migraine mob hnyav los yog mob hnyav; tsis zoo li txoj kev tshawb fawb INTERCEPT, AXS- tau muab thaum cov tsos mob ntxov tshaj plaws ntawm migraine tshwm sim. 07 kev kho. Ob qhov kev sim no tau lees paub tias kev kho mob AXS-07 tau pom zoo tshem tawm cov mob migraine thiab cov tsos mob uas cuam tshuam tshaj plaws piv nrog cov placebo thiab cov tshuaj tswj tau zoo.

Cov txiaj ntsig kev tshawb fawb MOMENTUM tau piav qhia hauv: MOMENTUM Theem 3 Kev sim Topline Cov txiaj ntsig. Cov txiaj ntsig ntawm INTERCEPT tau qhia meej hauv: INTERCEPT Phase 3 Trial Topline Results.

Herriot Tabuteau, MD, CEO ntawm Axsome tau hais tias:" FDA' qhov kev lees txais ntawm NDA rau AXS-07 yog qhov tseem ceeb tshaj plaws rau Axsome vim nws coj peb los ze zog los muab kev kho ntau yam txheej txheem. rau cov neeg mob migraine xav tau kev pab. Peb tos ntsoov yuav tshuaj xyuas nws. Txuas ntxiv mus cuam tshuam nrog FDA hauv cov txheej txheem."

MOSEIC technology

MOMENTUM yog ib qho randomized, ob-dig muag, placebo-tswj thiab zoo-tshuaj-tswj Phase III mus sib hais, ua raws li FDA Cov Kev Ntsuas Tshwj Xeeb (SPA), los ntsuas qhov ua tau zoo thiab kev ua tau zoo ntawm AXS-07 hauv kev kho mob me me rau mob hnyav migraine kev nyab xeeb. Txoj kev tshawb no tau siv Cov Lus Nug Txog Kev Kho Mob Migraine Optimization [mTOQ-4] los ntsuas, thiab tsuas yog suav nrog cov neeg mob uas muaj keeb kwm tsis txaus rau kev kho mob migraine yav dhau los. Hauv txoj kev tshawb no, tag nrho ntawm 1594 tus neeg mob tau muab tso rau ntawm qhov sib piv ntawm 2: 2: 2: 1 kom tau txais AXS-07 (20mg MoSEIC meloxicam / 10mg rizatriptan), rizatriptan (10mg), MoSEICmeloxicam(20mg), kev kho cov placebo. Ob lub ntsiab lus tseem ceeb ntawm txoj kev tshawb no yog qhov feem pua ​​​​ntawm cov neeg mob uas mob taub hau raug tshem tawm 2 teev tom qab kev tswj hwm ntawm AXS-07, thiab qhov feem pua ​​​​ntawm cov neeg mob uas feem ntau cuam tshuam txog migraine cov tsos mob ( xeev siab, photophobia, lossis soundphobia) raug tshem tawm. hauv 2 teev tom qab kev tswj hwm ntawm AXS-07.rizatriptan uayog ib qho tshuaj tswj tau zoo hauv txoj kev tshawb fawb thiab suav tias yog ib qho tshuaj zoo tshaj plaws rau migraine.

Cov txiaj ntsig tau pom tias txoj kev tshawb fawb tau mus txog ob qho tseem ceeb kawg, thiab cov ntaub ntawv tseem ceeb heev: 2 teev tom qab kev tswj hwm, piv nrog cov placebo pab pawg, ntau dua ntawm cov neeg mob hauv pab pawg kho mob AXS-07 tau ua tiav qhov mob nyem (19.9% ​​vs. 6.7%, p< 0.001)="" thiab="" tsis="" muaj="" cov="" tsos="" mob="" ntxhov="" siab="" tshaj="" plaws="" (36.9%="" vs="" 24.4%,="" p="0.002)." tsis="" tas="" li="" ntawd,="" axs-07="" kuj="" ua="" tiav="" qhov="" zoo="" tshaj="" plaws="" tau="" teev="" tseg="" hauv="" spa="">rizatriptan ua, MOSEICmeloxicam, thiab cov placebo: ntau dua ntawm cov neeg mob ua tiav qhov mob 2-24 teev tom qab kev tswj hwm Kev tshem tawm (feem ntau: 16.1%, 11.2%, 8.8%, 5.3%; p=0.038, p=0.001, p< 0.001).="" .="" cov="" txiaj="" ntsig="" zoo="" ntawm="" cov="" ntsiab="" lus="" tseem="" ceeb="" ntawm="" qhov="" kawg="" thiab="" cov="" ntaub="" ntawv="" pov="" thawj="" txhawb="" nqa="" kev="" tswj="" hwm="" kev="" xa="" tawm="" ntawm="" axs-07="" rau="" daim="" ntawv="" thov="" tshuaj="" tshiab="" (nda)="" rau="" kev="" kho="" mob="">

MOMENTUM Kawm Primary Endpoint& Cov ntsiab lus tseem ceeb Secondary Endpoint

Tsis tas li ntawd, piv nrog cov placebo thiabrizatriptan ua, AXS-07 muab kev kawm ntau dua thiab ntev dua kev kho mob migraine, thiab kev siv tshuaj kho mob migraine tau txo qis. Qhov feem pua ​​​​ntawm cov neeg mob uas muaj kev mob siab rau 2-24 teev tom qab kev tswj hwm yog 53.3% hauv pawg AXS-07, 33.5% hauv pawg placebo, thiab 43.9% hauv cov placebo.rizatriptan uapab pawg (piv nrog AXS-07, raws li, p< 0.001,="" p="0.006)." qhov="" feem="" pua="" ​​​​ntawm="" cov="" neeg="" mob="" uas="" muaj="" kev="" mob="" tshwm="" sim="" tsis="" pub="" dhau="" 2-48="" teev="" kuj="" tseem="" ceeb="" dua,="" 46.5%="" hauv="" pawg="" axs-07,="" 31.1%="" hauv="" pawg="" placebo,="" thiab="" 36.5%="" hauv="" pawg="" rizatriptan="" (piv="" rau="" axs-07="" pawg,="" raws="" li="">< 0.001,="" p="0.003)." qhov="" feem="" pua="" ​​​​ntawm="" cov="" neeg="" mob="" uas="" siv="" tshuaj="" cawm="" siav="" yog="" 23.0%="" hauv="" pawg="" axs-07,="" 43.5%="" hauv="" pawg="" placebo,="" thiab="" 34.7%="" hauv="" pawg="" rizatriptan="" (piv="" nrog="" axs-07,="" ob="" qho="" tib="" si=""><>