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Njira Yatsopano Yochepetsera Kuwonda Imawonetsa Lonjezo kwa Onenepa

Written by mkonzi

Rivus Pharmaceuticals Inc., kampani ya biopharmaceutical yodzipereka kupititsa patsogolo thanzi la cardio-metabolic, lero yalengeza zotsatira zabwino kuchokera ku mayeso achipatala a Phase 2a a HU6 mwa otenga nawo mbali onenepa omwe ali ndi mafuta ochulukirapo a chiwindi. M'masabata asanu ndi atatu, HU6 inawonetsa kuchepa kwakukulu kwa chiwindi, mafuta a visceral, ndi mafuta a thupi lonse pamene ikusunga minofu ya chigoba, zomwe zinapangitsa kuchepetsa kwambiri kulemera kwa thupi lonse. Mwapadera, kuchepa kwakukulu kwa kulemera ndi mafuta amthupi kunawonedwa mwa odwala omwe anali ndi milingo yayikulu ya HbA1c. Kuwongolera kudawonedwanso pazigawo zazikulu za metabolic zomwe zimayendetsa matenda amtundu wa 2 shuga, kulephera kwamtima ndi kagawo kakang'ono ka ejection (HFpEF), ndi non-alcoholic steatohepatitis (NASH). HU6 idaloledwa bwino pamiyeso yonse yophunziridwa.               

HU6 Phase 2a Metabolic Trial Design ndi Zotsatira

Mayesero a 2a a metabolic a HU6 anali kuyesa kwamasiku 61 osasinthika, osawona kawiri, oyendetsedwa ndi placebo opangidwa kuti awone chitetezo ndi mphamvu ya milingo itatu ya HU6 (150 mg, 300mg, ndi 450 mg) mwa otenga nawo gawo onenepa (thupi). misa index 28 mpaka 45 kg / m2) yokhala ndi mafuta ochulukirapo a chiwindi (oposa 8%). Otsatira makumi asanu ndi atatu (80) azaka zapakati pa 28 ndi 65 adatumizidwa mwachisawawa ku gulu limodzi mwamagulu atatu a chithandizo cha HU6 kapena gulu lofananira la placebo, otsekeredwa ndi otsekeredwa pamilingo ya HbA1c ya 5.7% kapena kupitilira apo, ndipo amamwa kamodzi patsiku (kusala kudya). Ophunzira adalangizidwa kuti asasinthe khalidwe pazakudya kapena kuchita masewera olimbitsa thupi. Chiyeso cha Phase 2a chinakumana ndi choyambirira (kuchepetsa mafuta a chiwindi ndi MRI-PDFF) ndi yachiwiri (kulemera kwa thupi ndi kuchepetsa mafuta ndi MRI ya m'mimba). Zotsatira zazikulu ndi zowonera zikuphatikiza:

• Mwachiwerengero (p <0.0001 ndi ANCOVA) kuchepetsa mafuta a chiwindi pamagulu atatu a mlingo.

o Kuchepetsa kwachibale kwamafuta a chiwindi kunali 33%, 43%, ndi 40% yofanana ndi oyankha (> 30% kuchepetsa wachibale) wa 40%, 71% ndi 72% pamiyeso yotsika, yapakati ndi yayikulu, motsatana, poyerekeza ndi wachibale wa placebo. kuchepetsa mafuta a chiwindi ndi 2% ndi oyankha ndi 5%.

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• Kuchepetsa kulemera kwa thupi makamaka chifukwa cha kutaya mafuta, kupulumutsa minofu ya chigoba pamilingo yonse ya masabata asanu ndi atatu, popanda kusintha kwa zakudya kapena kuchita masewera olimbitsa thupi.

o Kulemera ndi kutaya mafuta kunasonyeza kuyankha kwa mlingo ndi otenga nawo mbali kutaya pafupifupi mapaundi a 6 (p <0.001, mlingo waukulu vs. placebo).

o Ophunzira omwe ali ndi ma HbA1c okwera adakumana ndi kulemera kwakukulu ndi kutaya mafuta, kutaya pafupifupi mapaundi a 10 (p<0.0001, mlingo waukulu vs. placebo). 

o Kutaya mafuta kunkawoneka m'magulu a chiwindi, a visceral, ndi a subcutaneous ndi MRI.

• Zizindikiro zazikulu zamtima ndi kagayidwe kachakudya pamilingo yonse ya mlingo kuphatikiza:

o Kutsika kwakukulu kumadalira mlingo wa albumin wa glycated, chizindikiro cha kuwongolera shuga ndi ntchito ya insulin.

o Kuchepetsa kwambiri kudalira kwa mlingo wa kutupa chizindikiritso champhamvu cha C-reactive protein (hsCRP), gawo lofunikira la chiopsezo cha mtima.

• HU6 idaloledwa bwino pamilingo yonse ya mlingo ndikutsata bwino kwambiri. Palibe Zowopsa Zowopsa kapena Imfa zomwe zidanenedwa. Kutsekula m'mimba kwapang'onopang'ono komanso kusefukira kwapang'onopang'ono ndizomwe zimanenedwa zambiri za The Treatment Emergent Adverse Events. Zambiri mwa zochitikazi zinali zochepa; mmodzi wa otenga nawo mbali anasiya HU6 chifukwa cha kutsekula m'mimba pa mkono wochepa wa mlingo pamene palibe amene anasiya kumwa kwambiri.

Ma CMA amapereka njira yatsopano, yoyezera kuti mutsegule kulumikiza kwa mitochondrial, njira m'thupi yomwe imayendetsa ndikuchotsa mphamvu. Ponyamula ma protoni kuchokera mu danga la mitochondrial intermembrane, CMAs amawonjezera makutidwe ndi okosijeni a shuga ndi mafuta, kwinaku akusungabe maziko omwewo a adenosine triphosphate (ATP). Kuyambitsa njirayi kumapangitsa kuti kuchepetsa komanso kupewa kudzikundikira kwamafuta m'thupi lonse.

Mu theka loyamba la 2022, Rivus akupitiliza pulogalamu yake yachipatala ya HU6 ndi kafukufuku wa Phase 2a mu kulephera kwa mtima ndi kusungidwa kwa ejection fracture (HFpEF) kuti azitsatiridwa ndi maphunziro a Phase 2b amtundu wa 2 shuga ndi non-alcoholic steatohepatitis (NASH).

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mkonzi

Mkonzi wamkulu wa eTurboNew ndi Linda Hohnholz. Amakhala ku eTN HQ ku Honolulu, Hawaii.

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