Biopharma company GSK (LSE: GSK) (NYSE: GSK) announced on Monday that it has secured Fast Track designation from the US FDA for bepirovirsen, an investigational antisense oligonucleotide (ASO) targeting chronic hepatitis B (CHB).
The designation expedites drug development for serious conditions with unmet medical needs. Bepirovirsen's potential was supported by phase IIb trials B-Clear and B-Sure, with ongoing phase III program B-Well.
CHB affects nearly 300 million people globally, with current treatments offering a less than 2-8% functional cure rate.
Bepirovirsen is in phase III development, showing promise for a clinically meaningful functional cure response when combined with oral nucleoside/nucleotide analogues.
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