I-Social Anxiety Disorder: Ukuvavanywa koNyango olutsha oluNgxamisekileyo

I-Bionomics Limited, inkampani yekliniki ye-biopharmaceutical, ibhengeze ukuba iqalise ulingo lwayo lwezonyango lweSigaba se-2 (iSifundo se-PREVAIL) ukuvavanya i-BNC210 yonyango olunzima lwe-Social Anxiety Disorder (SAD), kunye neziphumo eziphambili ezilindelekileyo ekupheleni kwe-2022.

I-BNC210 ngomlomo, i-proprietary, i-modulator ye-allosteric ekhethiweyo ye-α7 nicotinic acetylcholine receptor ekuphuhliseni unyango olunzima lwe-SAD kunye nonyango olungapheliyo lwe-Post-Traumatic Stress Disorder (PTSD), kunye ne-US Food and Drug Administration (FDA) kuzo zombini izibonakaliso zeklinikhi.

I-PREVAIL Study SAD protocol yacinywa yi-FDA ngoNovemba ka-2021, kwaye yamkelwa imvume yokuziphatha yibhodi ephakathi yase-US yokuphonononga iziko (IRB) ngoDisemba ka-2021. Ngezi mvume zikhoyo, kunye nokuvunywa kwinqanaba lesayithi, iziza zekliniki. e-US ngoku zivuliwe kwaye zivulelekile ekuhlolweni abathathi-nxaxheba abanokubakho kuphononongo abaneminyaka eyi-18 ukuya kwi-65 yeminyaka ubudala ephawulwe kwi-SAD enzima. Abathathi-nxaxheba kuphononongo kuya kufuneka babe namanqaku angama-70 ubuncinci kwiLiebowitz Social Anxiety Scale, isikali esivavanya inqanaba lesigulane elixeliweyo le-social phobia kuluhlu lweemeko zentlalo kunye nokusebenza. Kucingelwa ukuba i-15 kwiindawo ze-20 zeklinikhi e-US ziya kubandakanyeka ekufuneni izigulane kolu phononongo.

Kolu vavanyo lwe-randomied, oluyimfama oluphindwe kabini, olulawulwa yi-placebo, i-BNC210 iya kuhlolwa njenge-acute, okanye idosi enye, unyango lwezigulane ezine-SAD. Abathathi-nxaxheba bophononongo baya kubelwa ngokungaqhelekanga kwelinye lamaqela amathathu onyango, i-225 mg BNC210, 675 mg BNC210 okanye i-placebo, malunga nabathathi-nxaxheba be-50 kwiqela ngalinye. Baza kulawulwa ngomlomo idosi enye yonyango lwabo abalunikiweyo malunga neyure enye phambi kokuthatha inxaxheba kumsebenzi wokuziphatha oxhokonxa ixhala oquka umngeni wokuthetha. Eyona njongo iphambili yophononongo kukuthelekisa inqanaba ledosi nganye ye-BNC210 ukuya kwi-placebo kumanqanaba okuxhalaba okuxelwe ngokwakho kusetyenziswa iiYunithi eziBalulekileyo zoKubandezeleka kweSikali (SUDS). Iinjongo zeSekondari ziquka ezinye izikali ezibini ezilinganisa amanqanaba okuxhalaba abathathi-nxaxheba (i-State-Trait Anxiety Inventory kunye neeNkcazo zokuZichaza ngexesha lokuThetha koLuntu), kunye novavanyo lokhuseleko kunye nokunyamezela kwe-BNC210 kulo luntu.

"Iziphazamiso zokuxhalaba zingumthwalo obalulekileyo kuluntu lwethu kwaye malunga ne-18 yezigidi zabantu abadala abanengxaki ye-Social Anxiety Disorder e-United States kuphela. Izigulana ngokuqhelekileyo ziya kuba noloyiko oluzingisileyo kunye nolunzulu lweemeko zentlalo okanye ezinxulumene nokusebenza xa bevezwe ngabantu abangaqhelekanga okanye kuphononongo olunokwenzeka ngabanye. Bahlala bebandakanyeka kwiindlela zokuziphatha zokuthintela ukulawula uloyiko lwabo, olunokuphazamisana nokusebenza, ukwandisa isithukuthezi kunye nokuhlukaniswa kwentlalo, kunye nokunciphisa umgangatho wobomi. Kukho isidingo esikhulu esingafezekiswanga sokusebenza ngokukhawuleza, unyango olufunekayo kwezi zigulana kuba amayeza e-FDA kuphela avunyiweyo e-Social Anxiety Disorder athatha iiveki ezininzi okanye ngaphezulu phambi kokuba abe nempembelelo kwiimpawu. Unyango olukhuselekileyo nolusebenzayo olufunwayo lunokunceda abantu abanengxaki yokuxhalaba kweNtlalo bazibandakanye, kunokuba baphephe, iimeko ezixhokonxa ixhala xa befuna kakhulu. ” utshilo abacebisi beBionomics kwiYunivesithi yaseCalifornia (eSan Diego) uGqr. UCharles Taylor (uNjingalwazi oDityanisiweyo, iSebe lezeNgqondo) noMurray Stein (uNjingalwazi oBalulekileyo, iSebe lezeNgqondo).

"I-tablet entsha eyenziwe nge-BNC210, efunxa ngokukhawuleza kwaye ifikelele ekugxininiseni okuphezulu egazini malunga neyure enye, ivavanywa kuphononongo lwe-PREVAIL njengonyango lomlomo olufunekayo kwizigulana ze-SAD ukuze zimelane ngcono nokulindela ukuxhalaba kwentlalo. unxibelelwano kunye nezinye iisetingi zoluntu. Sijonge phambili ekuthatheni ithuba lokutyunjwa kwe-Fast Track kuzo zombini izibonakaliso zonyango lwe-SAD kunye ne-PTSD, kwaye injongo yethu kukunika ingxelo yedatha ephezulu ngasekupheleni kuka-2022 kwi-PREVAIL Study naphakathi kuka-2023 kwiSigaba se-2b se-PTSD ATTUNE eqhubekayo. utshilo uSihlalo oLawulayo weBionomics, uGqr Errol De Souza.