Ua hoʻolaha ʻo Binomics Limited, kahi hui biopharmaceutical clinical-stage, ua hoʻomaka ʻo ia i kāna hoʻokolohua lapaʻau Phase 2 (ka PREVAIL Study) e loiloi i ka BNC210 no ka mālama ʻana i ka Social Anxiety Disorder (SAD), me nā hopena topline i manaʻo ʻia e ka hopena o 2022.

ʻO ka BNC210 he waha, proprietary, selective negative allosteric modulator o ka α7 nicotinic acetylcholine receptor i ka hoʻomohala ʻana no ka mālama ʻana i ka SAD a me ka mālama mau ʻana o ka Post-Traumatic Stress Disorder (PTSD), me ka US Food and Drug Administration (FDA) Fast Track designation. no nā hōʻailona lapaʻau ʻelua.

Ua hoʻomaʻemaʻe ʻia ka protocol PREVAIL Study SAD e ka FDA i Nowemapa 2021, a ua hāʻawi ʻia ia i ka ʻae ʻia e ka US Institutional Review Board (IRB) ma Dekemaba 2021. i ka US ua ho'ā 'ia a wehe 'ia i ka nānā 'ana no ka poʻe i komo i loko o ka haʻawina mai 18 a 65 makahiki me ka SAD koʻikoʻi. Pono nā haumāna e aʻo i ka helu o ka liʻiliʻi he 70 ma ka Liebowitz Social Anxiety Scale, ʻo ia ka pālākiō e loiloi i ka pae i hōʻike ʻia o ka social phobia ma nā ʻano o ka nohona a me ka hana. Manaʻo ʻia ʻo 15 a 20 mau kahua lapaʻau ma US e komo i ka ʻimi ʻana i nā maʻi no kēia noiʻi.

I loko o kēia hoʻokolohua hoʻāʻo ʻole, pālua-makapō, placebo-controlled trial, BNC210 e loiloi ʻia ma ke ʻano he lāʻau acute, a hoʻokahi-dose, lapaʻau no nā maʻi me SAD. E hāʻawi wale ʻia nā mea noiʻi i kekahi o nā hui lapaʻau ʻekolu, 225 mg BNC210, 675 mg BNC210 a i ʻole placebo, me kahi o 50 mau mea komo i kēlā me kēia hui. E hāʻawi waha ʻia lākou i hoʻokahi maʻa o kā lākou lapaʻau i hāʻawi ʻia ma kahi o hoʻokahi hola ma mua o ka komo ʻana i kahi hana hoʻonāukiuki hoʻonāukiuki e pili ana i kahi paʻakikī ʻōlelo. ʻO ka pahuhopu nui o ke aʻo ʻana, ʻo ia ka hoʻohālikelike ʻana i kēlā me kēia pae kiʻekiʻe o ka BNC210 i kahi placebo ma nā pae hopohopo hōʻike pilikino me ka hoʻohana ʻana i ka Subjective Units of Distress Scale (SUDS). Loaʻa i nā pahuhopu lua ʻelua mau unahi ʻē aʻe e ana i nā pae hopohopo o nā mea komo (State-Trait Anxiety Inventory a me Self-Statements During Public Speaking), a me ka loiloi o ka palekana a me ka hoʻomanawanui o BNC210 i kēia heluna.

"He mea kaumaha nui nā maʻi hopohopo no ko mākou kaiāulu a ma kahi o 18 miliona mau mākua i loaʻa i ka Social Anxiety Disorder ma United States wale nō. E ʻike maʻamau ka poʻe maʻi i ka makaʻu mau a me ka makaʻu nui i ka pilikanaka a i ʻole nā kūlana pili i ka hana ke ʻike ʻia i nā poʻe kamaʻāina ʻole a i ʻole ke nānā ʻia e nā poʻe ʻē aʻe. Hoʻohana pinepine lākou i nā ʻano pale e mālama i ko lākou hopohopo, hiki ke hoʻopilikia i ka hana, hoʻonui i ka mehameha a me ka noho kaʻawale ʻana, a hoʻemi i ka maikaʻi o ke ola. Loaʻa kahi pono kūpono ʻole no ka hana wikiwiki, e like me ka pono o kēia mau maʻi no ka mea ʻo nā lāʻau lapaʻau FDA wale nō i ʻae ʻia no Social Anxiety Disorder e lawe i kekahi mau pule a i ʻole ma mua o ka hopena o nā hōʻailona. Hiki i nā lāʻau lapaʻau palekana a maikaʻi hoʻi ke kōkua i ka poʻe me ka Social Anxiety Disorder e komo pū me, ma mua o ka pale ʻana i nā kūlana hoʻonāukiuki i ka wā e pono ai lākou. i'ōleloʻia e nā mea kūkākūkā o Bionomics ma ke Kulanui o Kaleponi (San Diego)ʻo Dr. ʻO Charles Taylor (Associate Professor, Department of Psychiatry) a me Murray Stein (Distinguished Professor, Department of Psychiatry).

"ʻO ka papa papa hou o BNC210, ka mea i hoʻopili koke ʻia a hiki i ka nui o ke koko i loko o hoʻokahi hola, ke loiloi ʻia nei ma ka PREVAIL study ma ke ʻano he lāʻau lapaʻau waha e pono ai no nā poʻe maʻi SAD e ʻoi aku ka maikaʻi o ka hoʻokō ʻana i ka manaʻo hopohopo. nā pilina a me nā hoʻonohonoho lehulehu ʻē aʻe. Ke kakali nei mākou i ka hoʻohana ʻana i nā koho ʻo Fast Track no nā hōʻailona mālama SAD a me PTSD, a ʻo kā mākou pahuhopu e hōʻike i ka ʻikepili topline i ka hopena o 2022 no ka PREVAIL Study a ma ka waena o 2023 no ka Phase 2b PTSD ATTUNE Study. wahi a ka Luna Hoʻokele o Bionomics, ʻo Dr. Errol De Souza.