Moprofesa Kyong Soo Park oa Sepetlele sa Seoul National University e le mofuputsi ea hokahanyang le bafuputsi ba ka sehloohong ba tsoang litsing tse 22 ba nkile karolo tekong ea kliniki ea mohato oa 3 bakeng sa Enavogliflozin e le monotherapy (thuto ea ENHANCE-A). Boithuto bona bo entsoe e le liteko tse ngata, tse sa boneng, tse foufetseng habeli, tse laoloang ke placebo, le tlhahlobo ea netefatso ea kalafo e nang le bakuli ba 160 ba nang le lefu la tsoekere la mofuta oa 2. Sepheo sa mantlha e ne e le ho etsa lipatlisiso ka phapang lipakeng tsa sehlopha sa Enavogliflozin le sehlopha sa placebo phetohong ea mantlha ea hemoglobin ea glycated (HbA1c). Ho ea ka tlaleho ea topline, e ile ea hlokomeloa pele e le 0.99% p libeke tse 24 ho tloha tsamaisong ea sehlahisoa sa lipatlisiso, se tiisitseng bohlokoa ba lipalo-palo (P-value <0.001). HbA1c, e leng sehlahisoa sa ho qetela sa hemoglobin e kopantsoeng le tsoekere ea mali, ke tekanyo ea khauta ea ho lekanya ho teba ha lefu la tsoekere.
Ntle le moo, ho bile le sephetho se setle sa thuto se bonoeng tekong e 'ngoe ea kliniki ea mohato oa 3 oa kalafo e kopaneng ea Enavogliflozin le metformin ke Daewoong Pharmaceutical (ENHANCE-M). Thuto ea ENHANCE-M e ne e tsamaisoa ke Moprofesa Gun Ho Yoon oa Univesithi ea K'hatholike ea Korea Seoul St. Mary's Hospital e le mofuputsi ea hokahanyang le bafuputsi ba ka sehloohong ba tsoang mekhatlong ea 23. Teko e entsoe le bakuli ba 200 ba nang le lefu la tsoekere la mofuta oa 2 ba nang le taolo e lekaneng ea tsoekere ea mali ka metformin. Ho ipapisitsoe le liphetho mabapi le phetoho ea mantlha ea HbA1c. Sehlopha sa bakuli ba ileng ba fuoa Enavogliflozin ka nako e tšoanang le metformin ba atlehile ho bonts'a ho se be tlase ho sehlopha se neng se tsamaisoa ka nako e tšoanang le Dapagliflozin le metformin. Sephetho sa polokeho sehlopheng se tsamaisoang ka Enavogliflozin le sona se netefalitsoe kaha ho ne ho se na liketsahalo tse mpe tse sa lebelloang kapa litlamorao tse mpe tsa lithethefatsi.
Bafuputsi ba itse, "Teko ea kliniki ea mohato oa 3 bakeng sa Enavogliflozin monotherapy (ENHANCE-A) le Metformin motsoako oa phekolo (ENHANCE-M) e nang le kakaretso ea barupeluoa ba 360 ba Korea ba bonts'itse phello e ntle ea ho theola tsoekere le polokeho ea moriana. Enavogliflozin e tla ba khetho e ntle ea kalafo ho bakuli ba nang le lefu la tsoekere la mofuta oa 2 haeba liphetho tse tšoanang li ka netefatsoa ho tsoa litlhare tse ling tse kopaneng.
Ha liphetho tsa bohlokoa li ile tsa fumanoa litekong ka bobeli tsa kalafo ea monotherapy le Metformin, Daewoong o thabetse ho hlahisa inhibitor e ncha ea SGLT-2 lekhetlo la pele Korea Boroa. Daewoong o rera ho etsa kopo hanghang bakeng sa tumello ea sethethefatsi se secha le ho qala eseng feela Enavogliflozin empa empa le Enavogliflozin/Metformin-Fixed-Dose-combination (FDC) ka 2023. Ho sa le joalo, Daewoong o ne a se a amohetsoe bakeng sa phuputso ea phase-1 ho leka thuto ea bioequivalence ea FDC ea Enavogliflozin le Metformin ka Pherekhong 2022.
"Ka katleho ea liteko tsa bongaka tsa morao-rao, re lebelletsoe ho fa bakuli ba lehae moriana o mocha oa naha o Molemo ka ho Fetisisa oa lefu la tsoekere haufinyane," ho boletse Sengho Jeon, CEO oa Daewoong Pharmaceutical. "Re tla leka ka matla ho lokolla sethethefatsi sa moloko o tlang le ho thusa ba nang le lefu la tsoekere le mathata, ha re ntse re boloka k'hamphani e ntse e hola."
SEO U LOKELANG HO SE NKA HO SEHLOOHO ENA:
- “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.
