Cali Biosciences Co., Ltd. ya sanar da sakamako mai nasara a cikin bincikensa na Phase IIb na samfurin sa na maganin analgesic na CPL-01, wani nau'in injectable na Naropin® (rovicaine hydrochloride), wanda Cali Biosciences ya haɓaka don kula da aikin bayan tiyata. ciwon tiyata da rage buƙatar opioids.
An tsara wannan gwaji na asibiti na Phase IIb don ƙarin bincika fa'idodin asibiti na CPL-01 kuma don kwatantawa da waɗanda ke da magungunan kula da ciwo a kasuwa. Gwajin ya nuna kyakkyawan sakamako-amsa ga inganci. A cikin adadin da aka tsara a halin yanzu a matsayin kashi na kasuwa, batutuwa na 14 da suka karbi CPL-01 sun nuna ma'anar AUC ta hanyar 72 hours na wWOCF gyara NRS-A (madaidaicin ƙarshen) na 286.8, yana nuna alamar mahimmanci ga batutuwa 13. wanda ya karɓi placebo (p=0.08) kuma ya fi dacewa da batutuwa 40 waɗanda suka karɓi Naropin®. An nuna ma'anar asibiti ta hanyar nuna bambanci fiye da aya AUC a kowace awa.
Bugu da ƙari, yin amfani da opioid ta hanyar 72 hours na batutuwa na CPL-01 waɗanda suka karbi kashi na kasuwa da aka yanke a rabi idan aka kwatanta da ko dai ƙungiyar placebo ko kungiyar Naropin® (ma'anar 7.9 MG, sabanin 15 MG don placebo da kuma). 16 MG don Naropin®). A zahiri, kusan 2/3 na batutuwan CPL-01 (9/14) ba su buƙatar opioids kwata-kwata bayan awanni 72 na farko bayan aikin, idan aka kwatanta da kusan rabin abubuwan Naropin® da 30% na placebo.
Babu wani binciken aminci mai ma'ana; kawai abubuwan da suka faru na rashin lafiya na gaggawa waɗanda suka faru a cikin fiye da ɗaya batun CPL-01 a duk ƙungiyoyin da ke cikin gwaji (n=40) sune tashin zuciya, amai, maƙarƙashiya, ciwon kai, da dizziness - duk abubuwan da suka faru bayan tiyata kuma suna iya faruwa. bayan amfani da opioids; Babu ɗayan waɗannan da aka yi tunanin yana da alaƙa da CPL-01.
Pharmacokinetics na miyagun ƙwayoyi ya ƙara goyan bayan amincinsa - dalili na farko da ake haɓaka ropivacaine mai tsayi, tare da fa'idodi masu fa'ida akan bupivacaine mai aiki mai tsawo a halin yanzu. Ma'anar Cmax don ropivacaine a cikin batutuwa waɗanda suka karɓi kashi na 600 MG shine 978 ng/mL, ƙasa da ƙasa da bakin kofa inda za'a iya ganin guba na zuciya (4000 ng/mL). CPL-01 ya kai matsakaicin maida hankali kamar sa'o'i 18 bayan gudanarwa, sabanin Naropin® (wanda ya kai shi cikin sa'a ta farko bayan gudanarwa).
ABUBUWAN DA ZA KU GUDU DAGA WANNAN LABARI:
- Additionally, opioid use through 72 hours of the CPL-01 subjects who received the to-be marketed dose was cut in half compared to either the placebo group or the Naropin® group (mean of 7.
- In fact, approximately 2/3 of the CPL-01 subjects (9/14) required no opioids at all after the first 72 hours after the operation, compared to roughly half of the Naropin® subjects and 30% of the placebo ones.
- In the dose currently planned as the to-be marketed dose, 14 subjects who received CPL-01 showed a mean AUC through 72 hours of wWOCF adjusted NRS-A (the primary endpoint) of 286.
