The P-IIb trial evaluates the efficacy & safety of ASC22 (1.0mg/kg, q2w) vs PBO in addition to NAs in 75 patients with CHB for 24wk. and then followed for another 24wks.
The results showed that 42.9% of patients with baseline HBsAg ≤100 IU/mL achieved sustained HBsAg loss, ALT flares were reported in 21% of patients while none in the PBO group with more HBsAg reduction, 2 out of 3 patients experienced ALT flares while 1 achieved sustained HBsAg loss starting @4wk. after 2 doses of ASC22
Patients experienced a transient seroconversion of anti-HBs @28wk. & stopped NAs treatment 3 days after 24wk. & HBsAg still remained negative until the end of the study, 97.5% were grade 1-2 & no study drug-related SAE was observed
Ref: PRNewswire | Image: Ascletis
