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.
- The actual data have not yet been released, and even when they are they will be hard to compare with a rival product, Mirum Pharmaceuticals’ volixibat, since that used a different measure in its mid-stage trial
PBC is a disease of the bile ducts that can cause liver damage, and like many autoimmune conditions mainly affects women. Cholestatic pruritus, a constant, relentless itching or skin-crawling sensation, is one of the most common PBC symptoms
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