Acadia Trofinetide Phase III Clinical Pamusoro-Line mhinduro yakanaka

Pa 2021-12-06, nguva yeUS, Acadia Pharmaceuticals (Nasdaq: ACAD) yakazivisa mhinduro yepamusoro-shuwa yeIII Clinical kutongwa kweMupi wayo anodhonza, trofinetide. Iyo phase III kuyedzwa, inonzi Lavender, inonyanya kushandiswa kuongorora kuchengetedza uye kushanda kweTrofinetide mune kurapwa kweRett syndrome (rs). Nhamba dzegumi nembiri dzakanyoreswa, vakadzi vese vane makore makumi mashanu nemashanu neRs.

Lavender aive akatongwa--mapofu, fungidziro yemavhiki gumi nemaviri aine mafungiro ekutanga eR rsfica Kiyi yechipiri Endpoint ndiko kutaurirana uye kufananidzira Budiridzo chiyero cheVacheche uye vana vezera revanhu, uye zvinogona kushanduka-shungu dzekuvandudza kurwadzisa uye kumwe kunonoka kwekusimudzira, sekusimudzira kunonoka, sekuongororwa kwevashandi vanovandudza.

Mhedzisiro yacho yakaratidza kuti trofinetide yaive nekuvandudzwa kwakakosha mumapapu ekutanga kufananidzwa nemacebo. Shanduko kubva kuBaseline muRSBQ yePlacebo uye Trofinetide pavhiki gumi nemaviri mairi -1.7 vs -5.1 (P = 0.0175); CGI-I ZVIMWE ZVAKAITWA 3.8 VS 3.5 (P = 0.0030). Zvichakadaro, shanduko kubva kuBaseline muCSB-DP-iyo-Yemagariro yaive -1.1 uye -0.1 yekuPlacebo uye trofinetide, zvichiteerana.

Vese vari vaviri vekutanga uye kunyanya vekondari endpoints yeLavender yakaratidza nezve trofinetside yeR rs, tiees Pakati pavo, zviitiko zvakajairika zvakanyanya zvaive:

① Dhairiya - Trofinetide yaive 80.6% (97.3% yeiyo yaive nyoro kune mwero) uye Placebo yaive 19.1%;

② kurutsa - Trofinetide yaive 26.9% (96% yeiyo yaive nyoro kune mwero) uye placebo yaive 9.6%;

Zviitiko zvakakomba zvinoitika zvakaitwa muzvinyorwa zvegumi nemazana emapoka mumapoka ari maviri.

Zvinyorwa muDhiteni Muedzo ucharamba uchigamuchira Trofinetide mushure mekupedza muyedzo kana Lilac-2 of the Lueld Ongororo Yekuvhurika