Ua komo ʻo Polofesa Kyong Soo Park o Seoul National University Hospital ma ke ʻano he mea noiʻi koʻikoʻi a me nā mea noiʻi nui mai 22 mau keʻena i komo i ka pae 3 hoʻokolohua lapaʻau no Enavogliflozin ma ke ʻano he monotherapy (ENHANCE-A study). Ua mālama ʻia ke aʻo ʻana ma ke ʻano he multicenter, randomized, double-blind, placebo-controlled, and therapeutic confirmatory trial i loaʻa i nā maʻi he 160 me ka maʻi diabetes type 2. ʻO ka hopena mua ʻo ia ke noiʻi ʻana i ka ʻokoʻa ma waena o ka hui Enavogliflozin a me ka hui placebo i ka hoʻololi kumu o ka hemoglobin glycated (HbA1c). Wahi a ka hōʻike topline, ua ʻike mua ʻia ʻo 0.99% p ma 24 mau pule mai ka hoʻokele ʻana o ka huahana hoʻokolokolo, i hōʻoia i ka nui o ka helu (P-value <0.001). ʻO ka HbA1c, kahi huahana hope loa o ka hemoglobin i hui pū ʻia me ka glucose koko, kahi ana maʻamau gula e hoʻoholo ai i ka paʻakikī o ka maʻi diabetes.

Eia kekahi, aia kahi hopena noiʻi maikaʻi i ʻike ʻia ma kahi hoʻokolohua lapaʻau ʻē aʻe 3 o ka hui pū ʻana o Enavogliflozin me ka metformin e Daewoong Pharmaceutical (ENHANCE-M). Ua mālama ʻia ke aʻo ʻana ʻo ENHANCE-M e Professor Gun Ho Yoon o ke Kulanui Katolika o Korea Seoul St. Mary's Hospital ma ke ʻano he mea noiʻi hoʻonohonoho a me nā mea noiʻi nui mai 23 mau kula. Ua mālama ʻia ka hoʻāʻo me 200 mau mea maʻi me ka maʻi maʻi type 2 i lawa ʻole ka mana o ka glucose koko me ka Metformin. Ma muli o nā hopena e pili ana i ka hoʻololi baseline o HbA1c. ʻO ka pūʻulu o nā mea maʻi i hoʻohana pū ʻia ʻo Enavogliflozin me ka Metformin i hōʻike maikaʻi ʻia i kona haʻahaʻa ʻole i ka hui i hui pū ʻia ʻo Dapagliflozin me Metformin. Ua hōʻoia pū ʻia ka hopena palekana i ka hui i hoʻohana ʻia me Enavogliflozin no ka mea ʻaʻohe hanana i manaʻo ʻole ʻia a i ʻole nā hopena ʻino i ka lāʻau.

Ua ʻōlelo ka poʻe noiʻi, "ʻO ka hoʻāʻo ʻana o ka lāʻau lapaʻau 3 no Enavogliflozin monotherapy (ENHANCE-A) a me Metformin hui pū ʻana (ENHANCE-M) me ka huina o 360 mau poʻe Korea i hōʻike i ka hopena hoʻohaʻahaʻa glucose a me ka palekana o ka lāʻau. E lilo ʻo Enavogliflozin i koho lapaʻau maikaʻi loa no nā poʻe maʻi me ka maʻi diabetes type 2 inā e hōʻoia ʻia nā hopena like mai nā lāʻau lapaʻau ʻē aʻe.

I ka loaʻa ʻana o nā hopena koʻikoʻi mai nā hoʻāʻo ʻelua no ka monotherapy a me ka hui pū ʻana o Metformin, hauʻoli ʻo Daewoong e ʻōwili i kahi mea hoʻopaneʻe SGLT-2 hou no ka manawa mua ma South Korea. Hoʻolālā ʻo Daewoong e noi koke no ka ʻae ʻana i ka lāʻau lapaʻau hou a e hoʻomaka ʻaʻole ʻo Enavogliflozin wale nō a akā ʻo Enavogliflozin/Metformin fixed-dose-combination (FDC) lāʻau i ka makahiki 2023. I kēia manawa, ua ʻae ʻia ʻo Daewoong no kahi haʻawina phase-1 e hoʻāʻo ai i ka noiʻi bioequivalence o FDC o Enavogliflozin a me Metformin i Ianuali 2022.

"Me ka kūleʻa o nā hoʻokolohua lapaʻau hou, manaʻo ʻia mākou e hāʻawi aku i nā poʻe maʻi kūloko i ka lāʻau lapaʻau Best-in-Class hou o ka ʻāina no ka maʻi maʻi i ka wā e hiki mai ana," wahi a Sengho Jeon, Daewoong Pharmaceutical CEO. "E hoʻoikaika mākou e hoʻokuʻu i ka lāʻau lapaʻau e hiki mai ana a kōkua i ka poʻe i loaʻa i ka maʻi maʻi a me nā pilikia, ʻoiai e mālama ana i ka ulu ʻana o ka ʻoihana."

He aha e lawe ʻia mai kēia ʻatikala:

“With the success of the recent clinical trials, we are expected to provide the local patients the country’s new Best-in-Class drug for diabetes in a near future,”.
Professor Kyong Soo Park of Seoul National University Hospital as a coordinating investigator and principal investigators from 22 institutions have participated in the phase 3 clinical trial for Enavogliflozin as a monotherapy (ENHANCE-A study).
The investigators said, “The phase 3 clinical trial for Enavogliflozin monotherapy (ENHANCE-A) and Metformin combination therapy (ENHANCE-M) with a total of 360 Korean participants have demonstrated outstanding glucose-lowering effect and safety of the drug.