Innovent announces that mazdutide (IBI362) has completed the first dose of mazdutide (IBI362) in a Phase III clinical study (DREAMS-1) in subjects with type 2 diabetes in China

Innovent Biopharmaceutical Group (HKEx stock code: 01801), a biopharmaceutical company dedicated to the development, production and marketing of innovative drugs for the treatment of major diseases such as oncology, autoimmunity, metabolism, ophthalmology, etc.
, announced: glucagon-like peptide-1 receptor (GLP-1R) / glucagon receptor, GCGR) dual agonist mazdutide (R&D code: IBI362) was administered
in a multicenter, randomized, double-blind, placebo-controlled phase III clinical study (DREAMS-1) in subjects with type 2 diabetes in China.

This study is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study (ClinicalTrials.
gov, NCT05628311)
to evaluate the efficacy and safety of IBI362 in Chinese patients with type 2 diabetes mellitus who have poor diet and exercise control alone.
The study planned to include approximately 300 participants randomized 1:1:1 to mazdutide 4.
0 mg, mazdutide 6.
0 mg, or placebo
.
The study treatment period totaled 48 weeks, including a 24-week double-blind treatment period and a 24-week study extension period
.
The primary endpoint of the study was change
in participants' glycated haemoglobin (HbA1c) levels from baseline at week 24.

Previously, the results of a phase II clinical study (ClinicalTrials.
gov, NCT04965506) in subjects with type 2 diabetes in China showed that mazdutide was well tolerated and the overall safety profile was similar to that of similar
drugs.
20 weeks after administration,

● The change in HbA1c from baseline was as high as -1.
67% in the mazdutide group (0.
03% in the placebo group and -1.
35% in the dulaglutide group)

● The percentage change in weight from baseline was as high as -7.
11% in the mazdutide group (-1.
38% in the placebo group and -2.
69% in the dulatide group)

● In addition, mazdutide can also reduce blood pressure, blood lipids and liver enzyme levels, bringing comprehensive benefits
to subjects.

This phase III clinical study DREAMS-1 will further verify the efficacy and safety
of long-term administration of mazdutide in Chinese patients with type 2 diabetes who do not have poor diet and exercise control alone.

Professor Zhu Dalong, the principal investigator of the study and Drum Tower Hospital affiliated to Nanjing University School of Medicine, said: "Diabetes has become a global health problem
.
At present, there are many kinds of drugs for the treatment of diabetes, and in recent years, GLP-1 receptor agonists have been widely used
because of their good efficacy and safety, especially cardiovascular protection 。 As a representative of the next generation of GLP-1 multi-target receptor agonists, mazdutide not only showed excellent hypoglycemic and weight reduction efficacy in clinical phase 2 studies, but also improved blood pressure, blood lipids, blood uric acid and liver enzymes, among which the composite endpoint of glucose reduction and weight reduction was effective in dulaglutide; Its overall safety profile is similar to that of marketed GLP-1 receptor agonist drugs; In addition, Mazdutide's once-a-week dosing regimen and the use of innovative auto-injectors without needles throughout the injection process can significantly improve patient quality of life and compliance
.
In DREAMS-1, I believe that through the joint efforts and solid work of researchers and sponsors, more excellent clinical research results will be achieved, mazdutide will be promoted to market as soon as possible, and new treatment options
will be brought to more patients with type 2 diabetes.
"

Professor Zhao Jiajun, the principal investigator of this study and Shandong Provincial Hospital, said: "In recent years, with the development of the national economy, the prevalence of diabetes and other metabolic diseases in China, such as obesity, gout, hyperlipidemia, etc.
, has gradually increased, especially patients with diabetes combined with a variety of diseases are often accompanied by significantly increased cardiovascular risk factors, which has led to an increasing
burden of disease and socio-economic burden of patients 。 There is an urgent need for treatments that can significantly improve blood glucose, body weight, and multiple cardiovascular risk factors; As a new GLP-1R/GCGR dual agonist in the world, mazdutide has a new mechanism, in addition to GLP-1 receptors, its additional excited glucagon receptors may bring benefits such as increasing basal metabolic rate, improving blood lipid profile, reducing liver fat, and strengthening appetite suppression; The results of the completed phase II clinical study of mazdutide in Chinese patients with type 2 diabetes showed its significant hypoglycemic and weight reduction efficacy and multiple metabolic benefits, and the results also showed that mazdutide has a good safety profile, revealing that it is expected to bring more potential therapeutic benefits
to patients than similar drugs under the premise of controllable safety.
I am very confident of the success of mazdutide in the Phase III clinical study and look forward to more surprises
from the GLP-1/GCGR agonist mazdutide.
" "

Dr.
Lei Qian, Vice President of Clinical Development, Innovent Biopharma Group, said, "mazdutide is a dual GLP-1R/GCGR agonist with both hypoglycemic and weight-reducing efficacy, and it has best-in-class potential in terms of efficacy
.
The phase II study results in Chinese subjects with type 2 diabetes fully proved the remarkable efficacy and good safety of mazdutide, showing its great application value
.
These results provide a solid basis for a phase III clinical study to evaluate the efficacy and safety
of mazdutide in Chinese subjects with type 2 diabetes mellitus who do not control diet and exercise alone.
We look forward to the success of mazdutide in the phase III clinical study and strive to provide more friendly, effective and safer clinical drug options
for the majority of type 2 diabetes patients as soon as possible.
" "