NeuroBo’s DA-1241 Receives the US FDA’s IND Clearance to Initiate the P-IIa Clinical Trial for Nonalcoholic Steatohepatitis
Shots:
- The US FDA has cleared an IND application to initiate a two-part P-IIa trial evaluating the efficacy of DA-1241 (GPR119 agonist) in a ratio (1:2:1) in part 1 into 3 treatment groups (DA-1241- 50/100mg, or PBO) & (2:1) in part 2 (DA-1241- 100mg/sitagliptin-100mg) in 55 & 43 patients. The trial is expected to initiate in Q3’23
- The 1EPs are the change from baseline in ALT levels @16wk. & the secondary efficacy EPs incl. normalization of ALT, relative percent change in a liver fat fraction from baseline, absolute change in liver fat from baseline & ≥30% reduction in liver fat from baseline. The safety will be evaluated by AEs, SAEs & AEs leading to discontinuation & laboratory abnormalities
- The therapy was well tolerated in the P-Ia/Ib studies in healthy volunteers & patients with T2DM
Ref: PRNewswire| Image: NeuroBo
Related News:- NeuroBo Entered into a Conditional Exclusive License Agreement with Dong-A to Develop and Commercialize DA-1241 and DA-1726
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