GSK’s Linerixibat GLISTENs In PBC Itching

But differences in trial design means it is hard to handicap GSK’s product against Mirum’s volixibat.

Itch

GSK’s linerixibat has hit the endpoints in its Phase III study in cholestatic pruritus in primary biliary cholangitis (PBC), setting it up for approval in this niche indication. But a rival agent, Mirum Pharmaceuticals’ volixibat, posted Phase IIb data in June, and when the full linerixibat data come out they will have to be judged as good as or better than volixibat’s if GSK’s drug is to be successful. However, differences in how the trials’ endpoints will likely mean such a judgement tricky to make.

Key Takeaways
  • GSK’s linerixibat has succeeded in its Phase III study in cholestatic pruritus – chronic itching – in primary biliary cholangitis, setting it up to become the first therapy approved specifically for this indication.

PBC is a disease of the bile ducts that can cause liver damage, and like many autoimmune conditions mainly affects...

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