Highlights

1.Clear MoA:

(1) Tirzepatide, dual GIP/GLP-1 receptor agonist synergizes with metabolic actions improves the efficacy and maximizes therapeutic benefits, but no significant change on decreasing the liver triglycerides and cholesterol.

(2) There are currently no approved treatments for NASH. The rising global prevalence of obesity, metabolic syndrome, and T2DM has driven a sharp increase in non-alcoholic steatohepatitis (NASH), affecting over 20 million patients.

(3) Fibroblast growth factor 21 (FGF21) deficiency favors the development of steatosis, inflammation, hepatocyte damage, and fibrosis in the liver, whereas administration of FGF21 analogs ameliorates NASH by attenuating these processes.

(4) Triple targets fusion protein, combining the activity of FGF21, GLP-1 and GIP, can reduce body weight & liver triglycerides /cholesterol, improve glucose control and treat NASH.

2.Excellent pre-clinical results:

Candidate has much better data in T2D/obesity related data (FPG/body weight change), PLUS the very comparable result in NAS score with same dosage of AKR001.
Candidate is far better than Tirzepatide in reducing body weight and ALT & AST level in the same dosage.
30 nmol/kg of candidate is slightly better than AKR001 in liver CHOI and liver TG in same dosage and surpass the result of Tirzepatide.

Project progress

Apr. 2024 IND in China & Apr. 2024 Phase I in AU