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Elafibranor (GFT505) Foda-Sabuwar Magunguna Don Nazarin Jiyya NASH

Menene Elafibranor (GFT505)?

Elafibranor (GFT505) foda (923978-27-2), magani ne na gwaji wanda har yanzu ana ci gaba da binciken sa. Ainihin, karatunsa da haɓaka shi da Genfit suna dogara ne akan ingancin Elafibranor (GFT505) foda (923978-27-2) a cikin yakar cutuka kamar cututtukan hanta masu yawan maye, dyslipidemia, insulin resistance, da ciwon suga.

Elafibranor (GFT505) tsarin aiwatarwa

Elafibranor (GFT505) foda magani ne na baki wanda ke aiki akan ƙananan abubuwa uku na PPAR. Sun hada da PPARa, PPARd, da PPARg. Koyaya, yana aiki akan PPARa.

Hanyar aikin Elafibranor yana da rikitarwa yayin da yake rarrabewa tsakanin masu rikice-rikice zuwa mai karɓar makaman nukiliya. Sakamakon haka, wannan yana haifar da bambancin tsarin kwayoyin halitta tare da tasirin kwayar halitta.

Elafibranor (GFT505) foda yana da ikon ganowa da kuma lalata aikin mai karɓar mai karɓar makamin nukiliya (SNuRMs). A sakamakon haka, yana ba da ingantaccen aiki tare da rage tasirin sakamako.

Dukansu kwayoyin sunadaran multimodal da sunadarai sun tabbatar suna da tasiri wajen yakar yanayi daban daban. Sun haɗa da juriya na insulin da ciwon sukari, kumburi, kiba, da lipid triad, wanda haɓakar haɓaka HDL cholesterol da rage ƙwayar LDL cholesterol da triglycerides.

Bambanci tsakanin tsarin aikin Elafibranor da na wasu mahadi waɗanda ke yin PPARs a cikin NASH (nonalcoholic steatohepatitis) shine gaskiyar cewa baya bayyanar da duk wani aikin Cutar magunguna.

Saboda, Elafibranor masu amfani ba su fuskantar tasirin sakamako mara amfani wanda ke hade da kunnawar PPARy. Irin waɗannan sakamako masu illa sun haɗa da; riƙewar ruwa, edema, da nauyin jiki waɗanda suke ƙaruwa da haɗarin mutum ga wahala daga bugun zuciya.

Elafibranor (GFT505) don nazarin ilimin Nash

NASH (nonalcoholic steatohepatitis) cuta ne na hanta wanda ke haifar da kumburi da lalacewar cututtukan hepatocytes gami da tara mai wanda kuma aka sani da saurin narkewa. Yawancin lokaci, wasu yanayin kiwon lafiya kamar cututtukan metabolism, nau'in ciwon sukari na 2, da kiba sune abubuwa na farko da ke haifar da rashin lafiyar steatohepatitis (NASH), da cututtukan hanta marasa ƙarfi (NAFLD).

Elafibranor (GFT505) Foda-Sabuwar Magunguna Don Nazarin Jiyya NASH

A yau, mutane da yawa suna fama da wannan cutar mai mutuƙar rai. Ban tsoro mai ban tsoro game da shi shine zai haifar da cutar cirrhosis, yanayin da zai sa hanta ta kasa aiki. Hakanan yana iya ci gaba zuwa cutar kansa hanta kuma a wasu halayen, haifar da mutuwa.

Labarin baƙin ciki game da NASH (nonalcoholic steatohepatitis) shine cewa ba ya zaɓar shekaru kuma yana ci gaba da shafar kowa. Mafi muni kuma shine, alamun cutar na iya zama asymptomatic, kuma mutum yana iya taɓa sani cewa suna fama da cutar har sai ta haɓaka zuwa matakin gaba.

NASHI da kumburi da NASH ya kawo (steatohepatitis mara amfani) kuma na iya haifar da cututtukan zuciya da na huhu. Tare da mutane da yawa a yanzu suna fama da wannan yanayin wanda ya samo asali daga cututtukan hanta marasa ƙwaƙwalwa, masu bincike suna neman zaɓuɓɓukan magani ban da aikin hanta.

Ofayan magungunan da ake binciken don maganin NASH shine Elafibranor (GFT505) foda (923978-27-2). Ya zuwa yanzu, ya nuna haifar da tasirin gaske akan manyan halaye guda biyu na cutar, watau ballooning da kumburi. Kyawun da ke tare da ita shi ne cewa yana da haƙurin gaske kuma ba zai sa mutum ya wahala daga kowace wahala ba. Saboda wannan dalili ne cewa Hukumar Abinci da Magunguna ta Amurka ta ba da saurin saurin wannan maganin ga NASH jiyya.

A halin yanzu, Elafibranor (GFT505) foda yana cikin gwajin asibiti na Phase 3, wanda aka yi masa lakabi da RESOLVE IT.

RA'AYIN-IT

Nazari ne na duniya wanda ya fara a farkon kwata na 2016, wanda bazuwar, placebo-sarrafawa cikin rabo 2: 1 da makafi biyu. Marasa lafiya waɗanda ke cikin wannan binciken sune waɗanda ke fama da cutar NASH (NAS> = 4) da fibrosis (matakan F2 ko F3 wanda ya rigaya aka san abin da lalacewar hanta .. A duk binciken, za a gudanar da marasa lafiya tare da Elafibranor (GFT505) sashi 120mg ko placebo sau ɗaya kowace rana.

Patientswararrun marasa lafiya dubu ɗaya da za a yi rajista zasu taimaka wajen nuna idan NASH ana iya magance shi tare da Elafibranor (GFT505) ba tare da cutar ta fibrosis ba idan aka kwatanta da waɗanda aka bi da placebo.

An yi rajistar rukunin farko a watan Afrilun 2018, kuma za a ba da rahoton sakamakon za a bayar da rahoto a ƙarshen 2019. Bayanin da aka bayar zai ƙayyade ko Hukumar Kula da Abinci da Abinci ta Amurka ta sami Elafibranor kamar yadda yake samun yardar ƙungiyar Hukumar Kula da Lafiya ta Turai, da kyau. da aka sani da EMA daga 2020.

Binciken ya ci gaba a wani mataki a watan Disamba na shekarar 2018 lokacin da Hukumar Kula da Kula da Lafiya ta Data (DSMB) ta amince da ci gaba da shari’ar ba tare da wani sauyi ba. Hakan ya biyo bayan bita ne da farko akan bayanan aminci da aka yi bayan watanni talatin.

Elafibranor (GFT505) Foda-Sabuwar Magunguna Don Nazarin Jiyya NASH

Sakamakon binciken ƙididdigar asali da na asibiti a cikin jiyya ga NASH

An kimanta inganci da amincin Elafibranor a cikin maganin NASH a baya ta hanyar nau'ikan cututtuka da yawa. A cikin 5 na 2a, an yi gwaje-gwaje daban-daban akan alkaluman mutane daban-daban na marasa lafiya da ke fama da cutar metabolism. Ya haɗa da waɗanda ke da nau'in ciwon sukari na 2 ko pre-diabetes da kuma atherogenic dyslipidemia. Yayin binciken, an lura cewa Elafibranor ya inganta;

  • Rage haɗarin wahala daga al'amuran zuciya
  • Rage alamomin rauni na hanta
  • Propertiesungiyoyin anti-kumburi
  • Sensara ƙwaƙwalwar insulin
  • Gulukos homeostasis
  • Profile lipid bayanin martaba.

Batun fitarwa na 2b wanda aka ƙaddamar a 2012 shine mafi girman fitinar shiga tsakani da kuma binciken farko na ƙasa da ƙasa da za a yi akan NASH. A lokacin ne Elafibranor ya cimma matsayar FDA ta ba da shawarar karshe game da “NASH Resolution ba tare da ci gaban Fibrosis ba.” Wancan shine babban batun farkon gwaji na duniya na 3 wanda har yanzu yana ci gaba.

An lura cewa marasa lafiya waɗanda suka sami NASH tare da Elafibranor sun lura da haɓakawa a cikin alamun lalata hanta kamar su ALP, GGT, da ALT. Ta hanyar kimantawa game da ƙarshen sakandare, an lura da cewa Elafibranor (GFT505) sashi na 120mg ya ba da tasirin warkewa a cikin abubuwan haɗari na cututtukan zuciya da ke hade da NASH, Sun haɗa;

  • Abubuwan da ke haifar da rigakafi
  • Ingantawa cikin ƙwayar insulin da metabolism metabolism a cikin marasa lafiya waɗanda ke da ciwon sukari
  • Inganta matakan lipoproteins da plasma lipids.
Tasiri na Elafibranor a cikin kulawa da cututtukan yara na NASH

Yawan yadda yara ke fama da kiba ya karu sosai, wanda hakan ke haifar da damuwa game da lafiyar. A cikin binciken da aka yi a shekarar 2016, an lura da hakan NAFLD(cututtukan hanta marassa ƙwaƙwalwa) yana shafar kusan 10-20% na yawan yara. Ya kara nuna cewa NAFLD na yara shine zai zama sanadin haifar da gazawar hanta, cututtukan hanta, gami da sanya hanta a cikin yara da matasa.

A cikin Janairu 2018 an gabatar da aikin hukuma na shirin ilimin yara na NASH tare da tuna cewa Elafibranor shine kawai magani wanda ya tabbatar da inganci a cikin maganin NASH a cikin manya kuma yana cikin matakan ci gaba a cikin kula da yara.

Shin ana iya amfani da Elafibranor tare da sauran magunguna a cikin maganin NASH?

Ya rigaya ya bayyana cewa Elafibranor yana da tasiri a cikin maganin NASH lokacin da aka yi amfani dashi da kansa. Koyaya, saboda caccakar cutar, ana iya amfani dashi tare da sauran magunguna don gudanar da cutar hanta, NASH, da cututtukan cututtukan su.

Elafibranor (GFT505) sauran amfani

A cikin cututtukan cutar cholstasis

Cholestasis wani yanayi ne wanda lalacewa ta kasance a cikin samuwar bile da gudanawar sa ta cikin gallbladder da duodenum. Zai iya haifar da ci gaba da cututtukan cututtukan cututtukan zuciya da cutar hanta, gazawar hanta, har ma da buƙatar juzuwar hanta. Wani bincike na asibiti da aka yi ya nuna cewa Elafibranor (GFT505) foda yana rage alamomin ƙirar ƙwayoyin cuta a cikin ƙwayar plasma saboda haka yana tabbatar da cewa yana iya zama da amfani ga maganin cutar cholestasis.

ciwon

Cutar sankarau wani yanayi ne da ake haifar dashi ta hanyar yin yawaitar sukari ko glucose a cikin jini. Ana shafar kusan mutane miliyan ɗari huɗu a duniya. Develoaya daga cikin su na haifar da nau'in ciwon sukari irin na 2 da zarar jikinsu ya gaza samarwa da amfani da insulin a koda yaushe.

Binciken da aka yi akan elafibranor ya nuna cewa yana rage ci gaban nau'in ciwon sukari na 2 a hanyoyi biyu. Na farko shine ta hanyar haɓaka metabolism a cikin jiki.

Hakanan yana inganta haɓakar insulin a cikin tsokoki da ƙirar mahaifa.

Elafibranor (GFT505) Foda-Sabuwar Magunguna Don Nazarin Jiyya NASH

Kammalawa

Nazarin na Elafibranor ya zo kamar kyakkyawan albishi ga duk wanda ke fama da matsalar NASH. Kasancewar an baka maganin fiye da dari takwas marasa lafiya har zuwa yau kuma yana nuna yana da amfani, akwai fatan cewa mutane ba za su sake yin aikin hanta ba.

Babu wani Hulɗa da magungunan Elafibranor gano tare da sitagliptin, simvastatin, ko warfarin, wanda ke nuna cewa za'a iya amfani dashi tare da sauran magunguna lafiya. Elafibranor yana da haƙuri a cikin jiki kuma baya nuna alamun sakamako masu illa.

References

  1. Hanyoyin Bincike Tsarin Fassara a cikin Cutar Cutar Cutar Cutar, Cutar Kiba, da Nonalcoholic Fatty, Andrew J. Krentz, Christian Weyer, Marcus Hompesch, Springer Nature, shafi na 261
  2. PPARs a cikin salon salula da - Duk Jikin kuzarin metabolism wanda Walter Wahli, Rahila Tee, 457-470
  3. Kiba mai yawa da Cutar Gastroenterology, Batun da aka samu na Clinics of North, Octavia Pickett-Blakely, Linda A. Lee, shafi na 1414-1420

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2019-07-23 kari
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