I-Social Anxiety Disorder: Ukuhlola Ukwelashwa Okusha Okubukhali

I-Bionomics Limited, inkampani ye-biopharmaceutical yesigaba somtholampilo, imemezele ukuthi isiqale uhlolo lwayo lomtholampilo lweSigaba 2 (Ucwaningo Lwe-PREVAIL) ukuze luhlole i-BNC210 yokwelashwa okubukhali kwe-Social Anxiety Disorder (SAD), ngemiphumela ephezulu elindelwe ekupheleni kuka-2022.

I-BNC210 iyimoduli yomlomo, yokuphathelene, ekhethiwe engalungile ye-allosteric ye-α7 nicotinic acetylcholine receptor ekuthuthukisweni ukwelashwa okunamandla kwe-SAD kanye nokwelashwa okungapheli kwe-Post-Traumatic Stress Disorder (PTSD), enegama le-US Food and Drug Administration (FDA) kuzo zombili izinkomba zomtholampilo.

Iphrothokholi ye-PREVAIL Study SAD yasulwa yi-FDA ngoNovemba 2021, futhi yanikezwa imvume yokuziphatha yibhodi elimaphakathi le-US Institutional Review Board (IRB) ngoDisemba 2021. Njengoba lezi zimvume zikhona, kanye nezimvume zezinga lesayithi, amasayithi omtholampilo. e-US manje sezicushiwe futhi zivulekele ukuhlolelwa abangaba ababambiqhaza bocwaningo abaneminyaka eyi-18 kuye kwengama-65 ubudala abamakwe ku-SAD enzima. Ababambiqhaza bocwaningo kuzodingeka babe namaphuzu okungenani angu-70 ku-Liebowitz Social Anxiety Scale, okuyisilinganiso esihlola izinga elibikiwe lesiguli le-phobia yomphakathi kuluhlu lwezimo zomphakathi nezokusebenza. Kulindeleke ukuthi izindawo zomtholampilo ezingu-15 kuya kwezingu-20 e-US zizobandakanyeka ekuqasheni iziguli zalolu cwaningo.

Kulolu hlolo olungahleliwe, olungaboni kabili, olulawulwa yi-placebo, i-BNC210 izohlolwa njengokwelashwa okunamandla, noma okukodwa, kweziguli ezine-SAD. Abahlanganyeli bocwaningo bazokwabelwa ngokungahleliwe kwelinye lamaqembu amathathu okwelapha, 225 mg BNC210, 675 mg BNC210 noma i-placebo, cishe nabahlanganyeli abangu-50 eqenjini ngalinye. Bazonikezwa ngomlomo umthamo owodwa wokwelashwa abawabelwe cishe ihora elilodwa ngaphambi kokuba babambe iqhaza emsebenzini wokuziphatha obangela ukukhathazeka ohlanganisa inselele yokukhuluma. Injongo eyinhloko yocwaningo ukuqhathanisa ileveli yomthamo ngamunye we-BNC210 ne-placebo emazingeni okukhathazeka azibike wona kusetshenziswa ama-Subjective Units of Distress Scale (SUDS). Izinjongo zesibili zihlanganisa ezinye izikali ezimbili ezikala amazinga okukhathazeka ababambiqhaza (I-State-Trait Anxiety Inventory kanye Nezitatimende Zakho Phakathi Nokukhuluma Umphakathi), kanye nokuhlolwa kokuphepha nokubekezelelana kwe-BNC210 kulesi sibalo.

“Izinkinga zokukhathazeka ziwumthwalo omkhulu emiphakathini yethu futhi abantu abadala ababalelwa ezigidini ezingu-18 bahlushwa yi-Social Anxiety Disorder e-United States kuphela. Iziguli ngokuvamile zizobhekana nokwesaba okungapheli nokunamandla kwezimo zomphakathi noma eziphathelene nokusebenza lapho zivezwe kubantu abangabajwayele noma ekuhlolweni okungase kube khona abanye. Ngokuvamile bazozibandakanya ekugwemeni ukuze balawule ukwesaba kwabo, okungaphazamisa ukusebenza, kwandise isizungu nokuzihlukanisa nomphakathi, futhi kunciphise izinga lempilo. Kunesidingo esikhulu esingahlangatshezwananga sokwelashwa okushesha, njengokudingeka kwalezi ziguli ngoba okuwukuphela kwemithi egunyazwe yi-FDA ye-Social Anxiety Disorder ithatha amasonto ambalwa noma ngaphezulu ngaphambi kokuba ithinte izimpawu. Izindlela zokwelapha eziphephile nezisebenzayo ezidingekayo zingasiza abantu abane-Social Anxiety Disorder ukuthi bahlanganyele, kunokuba bagweme, izimo ezibangela ukukhathazeka lapho bezidinga kakhulu. " kusho abeluleki beBionomics eNyuvesi yaseCalifornia (San Diego) uDkt. UCharles Taylor (uProfesa Ohlangene, uMnyango Wezengqondo) noMurray Stein (uProfesa Ohloniphekile, uMnyango Wezengqondo).

"Ukwakhiwa kwethebhulethi entsha ye-BNC210, emuncwa ngokushesha futhi efinyelela ekugxilweni okuphezulu egazini cishe ngehora elilodwa, iyahlolwa ocwaningweni lwe-PREVAIL njengokwelashwa ngomlomo njengoba kudingwa iziguli ze-SAD ukuze zibhekane kangcono nomphakathi okulindelekile obangela ukukhathazeka. ukusebenzisana nezinye izilungiselelo zomphakathi. Sibheke ngabomvu ukusizakala ngokuqokwa kwe-Fast Track yakho kokubili izinkomba zokwelashwa kwe-SAD ne-PTSD, futhi umgomo wethu uwukubika idatha ebaluleke kakhulu ngasekupheleni kuka-2022 yoCwaningo Lwe-PREVAIL futhi maphakathi no-2023 ocwaningweni oluqhubekayo lweSigaba 2b se-PTSD ATTUNE." kusho uSihlalo Omkhulu we-Bionomics, uDkt. Errol De Souza.