Adiso Therapeutics, Inc bugun neytrofillar savdosi va faollashuvining og'zaki, ichak-cheklangan, kichik molekula modulyatori ADS1 (BT051) ni potentsial davolash sifatida baholovchi 051b-bosqich klinik tadqiqotida bemorlarning birinchi guruhini ro'yxatga olishni yakunlaganini e'lon qildi. O'rtacha va og'ir faol ülseratif kolit (UC) bilan og'rigan bemorlar uchun. Ko'r bo'lmagan ma'lumotlar ushbu kogortada dozalash xavfsiz va yaxshi muhosaba qilinganligini ko'rsatdi, bu esa ikkinchi yuqori dozali kogortani ro'yxatga olishni boshlashni qo'llab-quvvatladi.
Ushbu faza 1b o'rtacha va og'ir faol UC (NCT05084261) bo'lgan bemorlarda randomizatsiyalangan, ikki marta ko'r, platsebo-nazorat qilinadigan, ko'p marta ortib borayotgan dozani o'rganishdir. Ushbu tadqiqotning asosiy maqsadi farmakokinetikaning ikkinchi darajali maqsadi bilan xavfsizlik va bardoshlik va neytrofillar bilan bog'liq biomarkerlarni kamaytirishning kashfiyot maqsadlari. Ushbu faza 1b tadqiqoti sog'lom ko'ngillilarda bir martalik ortib borayotgan dozani o'rganish bo'yicha 1a bosqichidan so'ng ADS051 dozani cheklovchi toksik ta'sirlar yoki jiddiy nojo'ya hodisalarsiz ichakda cheklanganligini ko'rsatdi.
“Neytrofillarni nishonga olish yarali kolitning asosiy patofiziologiyasini davolashning yangi strategiyasidir. Ushbu faza 1b tadqiqoti ADS051ning yo'g'on ichakdagi o'tkir yallig'lanish jarayoni davom etayotgan yo'g'on ichakdagi neytrofillarning ko'chishi va faollashuviga olib keladigan asosiy yo'llarni qanday xavfsiz va samarali tarzda inhibe qilishi mumkinligini o'rganishdagi navbatdagi qadamdir. Ushbu tadqiqotda biz farmakologik faollikning biomarkerlarini va klinik faollikning dastlabki belgilarini qidiramiz, bu esa yo'g'on ichak yallig'lanishining kamayishiga olib keladi va o'rtacha va og'ir UC bilan og'rigan bemorlarda shilliq qavatning tiklanishiga yordam beradi ", dedi Skott Megaffin, bosh ijrochi direktori Adiso. "ADS051 ning klinik rivojlanishini davom ettirish, neytrofillar savdosiga xos bo'lgan bir nechta ichakni cheklovchi terapiyaga ega bo'lgan UC bilan og'rigan bemorlarga sezilarli darajada qondirilmagan ehtiyojni hisobga olgan holda muhim ahamiyatga ega."
USHBU MAQOLADAN NIMA OLISH KERAK:
- today announced that it has completed enrollment of its first cohort of patients in a Phase 1b clinical study evaluating ADS051 (BT051), an oral, gut-restricted, small molecule modulator of neutrophil trafficking and activation, as a potential treatment for patients with moderately-to-severely active ulcerative colitis (UC).
- This Phase 1b study is the next step in exploring how ADS051 may safely and effectively inhibit key pathways known to cause the migration and activation of neutrophils in the colon where the acute inflammatory process in UC is ongoing.
- In this study we will look for biomarkers of pharmacological activity and early signs of clinical activity that may translate into reductions in colonic inflammation and promote mucosal healing in patients with moderate-to-severe UC,”.
