GSK announces B-Wells trials of bepirovirsen met primary endpoint

GSK (GSK) announced positive results from its two phase III trials, B-Well 1 and B-Well 2, evaluating bepirovirsen, an investigational antisense oligonucleotide, ASO, for the treatment of chronic hepatitis B, CHB, in over 1,800 patients from 29 countries. The B-Well trials met their primary endpoint, and bepirovirsen demonstrated a statistically significant and clinically meaningful functional cure rate. Functional cure rates were significantly higher with bepirovirsen plus standard of care compared with standard of care alone. Results were statistically significant across all ranked endpoints, including in patients with baseline surface antigen less than=1000 IU/ml where an even greater effect was demonstrated. The trials demonstrated an acceptable safety and tolerability profile consistent with what was reported in other studies.