Bionomics Limited, kampani yachipatala ya biopharmaceutical, yalengeza kuti yayamba kuyesa kwachipatala kwa Phase 2 (Phunziro la PREVAIL) kuti liwunikire BNC210 ya chithandizo chambiri cha Social Anxiety Disorder (SAD), ndi zotsatira zapamwamba zomwe zikuyembekezeredwa kumapeto kwa 2022.
BNC210 ndi oral, proprietary, selective negative allosteric modulator ya α7 nicotinic acetylcholine receptor mu chitukuko cha chithandizo chamankhwala cha SAD ndi matenda aakulu a Post-Traumatic Stress Disorder (PTSD), ndi US Food and Drug Administration (FDA) Fast Track dzina. pa zizindikiro zonse zachipatala.
Ndondomeko ya PREVAIL Study SAD idayeretsedwa ndi FDA mu Novembala 2021, ndipo idavomerezedwa ndi bungwe lapakati la US Institutional Review Board (IRB) mu Disembala 2021. ku US tsopano atsegulidwa ndikutsegulidwa kuti awonedwe kwa omwe angatenge nawo kafukufuku wazaka za 18 mpaka 65 wazaka zodziwika ndi SAD yoopsa. Otenga nawo mbali paphunziro adzafunika kukhala ndi ziwerengero zosachepera 70 pa Liebowitz Social Anxiety Scale, yomwe ndi sikelo yomwe imawunika momwe wodwalayo alili wodana ndi anthu m'malo osiyanasiyana komanso momwe amagwirira ntchito. Zikuyembekezeka kuti 15 mpaka 20 malo azachipatala ku US atenga nawo gawo polemba odwala ku kafukufukuyu.
M'mayeserowa osasintha, akhungu awiri, oyendetsedwa ndi placebo, BNC210 idzayesedwa ngati chithandizo chamankhwala, kapena mlingo umodzi, kwa odwala omwe ali ndi SAD. Otenga nawo mbali paphunziro adzapatsidwa mwachisawawa ku gulu limodzi mwamagulu atatu a chithandizo, 225 mg BNC210, 675 mg BNC210 kapena placebo, ndi otenga nawo gawo pafupifupi 50 pagulu lililonse. Adzaperekedwa pakamwa mlingo umodzi wa chithandizo chomwe apatsidwa pafupifupi ola limodzi asanayambe kuchita nawo ntchito yodzetsa nkhawa yokhala ndi vuto lolankhula. Cholinga chachikulu cha phunziroli ndikufanizira mulingo uliwonse wa BNC210 ndi placebo pamilingo yodziwonetsa yokha ya nkhawa pogwiritsa ntchito Subjective Units of Distress Scale (SUDS). Zolinga zachiwiri zikuphatikiza masikelo ena awiri oyesa kuchuluka kwa nkhawa kwa omwe atenga nawo mbali (State-Trait Anxiety Inventory and Self-Statements during Public speaker), komanso kuwunika kwachitetezo ndi kulekerera kwa BNC210 pagululi.
“Nkhawa ndi katundu wolemetsa m’madera athu ndipo pafupifupi akuluakulu 18 miliyoni amadwala matenda a Social Anxiety Disorder ku United States kokha. Odwala nthawi zambiri amakhala ndi mantha opitilira apo komanso okhudzana ndi zochitika zokhudzana ndi chikhalidwe cha anthu kapena momwe amagwirira ntchito akakumana ndi anthu osadziwika kapena kufufuzidwa ndi ena. Nthawi zambiri amachita zinthu zopewera kuwongolera mantha awo, zomwe zingasokoneze kugwira ntchito, kukulitsa kusungulumwa komanso kudzipatula, ndikuchepetsa moyo wabwino. Pali kufunikira kwakukulu kosakwanira kwa chithandizo chofulumira, monga chofunikira kwa odwalawa chifukwa mankhwala okhawo ovomerezeka a FDA a Social Anxiety Disorder amatenga milungu ingapo kapena kupitilira apo asanakhudze zizindikiro. Chithandizo chotetezeka komanso chothandiza chomwe munthu angafunikire chingathandize anthu omwe ali ndi Social Anxiety Disorder kuti azichita nawo, m'malo mopewa, zinthu zodetsa nkhawa pakafunika kwambiri. ” anatero alangizi a Bionomics ku yunivesite ya California (San Diego) Dr. Charles Taylor (Pulofesa Wothandizira, Dipatimenti ya Psychiatry) ndi Murray Stein (Pulofesa Wodziwika, Dipatimenti ya Psychiatry).
"Mapangidwe atsopano a piritsi a BNC210, omwe amalowetsedwa mwachangu ndikufikira kuchuluka kwa magazi pafupifupi ola limodzi, akuwunikidwa mu phunziro la PREVAIL ngati chithandizo chapakamwa chomwe chikufunika kwa odwala a SAD kuti athe kuthana ndi vuto lomwe likuyembekezeredwa loyambitsa nkhawa. kuyanjana ndi zina zowonekera pagulu. Tikuyembekeza kutengerapo mwayi pamatchulidwe a Fast Track pazizindikiro za chithandizo cha SAD ndi PTSD, ndipo cholinga chathu ndikupereka lipoti lapamwamba kumapeto kwa 2022 pa Phunziro la PREVAIL komanso pakati pa 2023 pa Phunziro lomwe likuchitika la Phase 2b PTSD ATTUNE. adatero Wapampando wamkulu wa Bionomics, Dr. Errol De Souza.
