DA-1241 Global Phase 2 Part 1 Patient Recruitment Completed
- 2024-04-05 오후 4:40:37
- 696
2024/04/02
Neurobo Pharmaceuticals, a subsidiary of Dong-A ST, announced on the 2nd that it has completed the recruitment of Part 1 patients in the global phase 2 clinical trial of "DA-1241," which is being developed as a treatment for metabolic steatohepatitis (MASH). Neurovo was approved by the U.S. Food and Drug Administration (FDA) in May last year and began administering its first patient in September of the same year.
DA-1241 Global Phase 2 clinical trial Part 1 is divided into a placebo group, a DA-1241 50mg group, and a DA-1241 100mg group for 29 MASH patients to evaluate efficacy and safety in a multicenter, randomized, double-blind, placebo-controlled, and parallel comparison method for 16 weeks.
Neurovo is also in the process of part 2 of the global phase 2 clinical trial of DA-1241. Part 2 confirms the efficacy and safety of co-administration of DA-1241 and sitagliptin. The Company plans to terminate both DA-1241 global Phase 2 clinical trials Part 1 and Part 2 in the second half of this year.
DA-1241 is the first-in-class new drug in the family of GPR119 agonists. The possibility of developing a MASH treatment was confirmed in the preclinical phase. After administration of DA-1241, improvement effects such as cirrhosis, inflammation, fibrosis, lipid metabolism, and glucose control were confirmed.
Neurovo is a Nasdaq-listed company located in Boston, USA, responsible for the global development and commercialization of DA-1241 and DA-1726. In February, the U.S. FDA approved a global phase 1 clinical trial for the obesity treatment DA-1726 that doubles on GLP-1, glucagon receptors. Phase 1 clinical trials are expected to begin in the second quarter of this year.
"The recruitment of patients for DA-1241 Global Phase 2 Clinical Part 1 has been completed smoothly, and we will also complete the recruitment of Part 2 patients as soon as possible," said Kim Hyung-heon, CEO of Neurobo. "We will do our best to complete the global phase 2 clinical trial in the second half of this year to create a safe and effective MASH treatment."