The 55th Annual Meeting of the European Association for the Study of Diabetes (EASD) was held in Barcelona, Spain from September 16 to 20, 2019, at which the results of Phase III PLEASE clinical research on the world's first once-weekly PEG GLP-1 receptor agonist, Polyethylene Glycol Loxenatide (PEX 168, brand name: Fulaimei) independently developed by Hansoh Pharma, were released.
GLP-1 receptor agonist drugs have been widely recognized by experts at home and abroad for the treatment of type II diabetes, and have been recommended by authoritative guidelines at home and abroad as first-line priority drugs or second-line preferred drugs. In May 2019, Hansoh Pharma’s Fulaimei became available in the market of China.
In this year's EASD poster session, the results of the PLEASE-1 monotherapy study, led by Professor Yang Wenying from China-Japan Friendship Hospital, were announced on the afternoon of September 17 local time. In this study, newly diagnosed T2DM patients whose blood glucose was not well controlled under diet control and exercise treatment were treated with different doses of Loxenatide (100ug/200ug), and the changes occurring in HbA1c, FPG, and 2 hPG were observed. The baseline HbA1c for the group of patients was 8.5%; the results showed that Loxenatide could effectively reduce HbA1c by an average of 1.2%-1.6%, significantly better than placebo. Moreover, the proportion for the Loxenatide group to reach the blood glucose standard was significantly higher than that for the placebo group. In addition, Loxenatide can effectively reduce FPG and 2hPG. Compared with the placebo group, FPG of the Loxenatide group decreased by 0.42 mM-1.07 mM (P<0.05), and 2 hPG decreased by 1.54 mM-2.56 mM (P<0.05).
Professor Yang Wenying commented that during the Phase III clinical study of Loxenatide, the patients showed good tolerance to Loxenatide, mainly with slight tolerable gastrointestinal adverse reactions, and the incidence of hypoglycemia and antibody remained at a low level.
The PLEASE-2 metformin combined therapy study led by Professor Jia Weiping from Shanghai Sixth People's Hospital, head of Shanghai Diabetes Research Institute, was presented orally on the morning of September 19 local time. PLEASE-2 aimed to verify the efficacy and safety of combined treatment with Loxenatide 100ug/200ug in T2DM patients for whom the monotherapy of metformin was not effective in blood glucose control. Compared with the monotherapy of metformin, the combined treatment with Loxenatide could significantly reduce HbA1c by 1.16% (P<0.001); after 24 weeks of combined treatment, obvious improvement was observed in both FPG and 2 hPG.
When being interviewed, Professor Jia Weiping said that in addition to the overall improvement realized by the combined treatment with Loxenatide and metformin in blood glucose control and target rate, all the tested patients showed a trend of weight loss during the research, indicating the potential of Fulaimei in weight loss and cardiovascular risk benefits.
Before the annual meeting of EASD, Professor Zhu Dalong from Nanjing Drum Tower Hospital was interviewed on the application status and prospect of GLP-1 receptor agonists. Professor Zhu said that GLP-1 receptor agonists, with their advantages in mechanism, have demonstrated pleiotropic effects in terms of blood glucose reduction, weight loss, and cardiovascular protection in clinical application. Hansoh Pharma's long-acting loxenatide preparation provides a new drug choice for type II diabetes patients. He hoped that more medical evidence would be explored in the future clinical practice focusing on Loxenatide as the core treatment means, so as to provide new treatment approaches and management schemes for diabetes patients in China, and even all around the world.
