1. Scrip
  2. >>R&D
  3. >>Clinical Trials

GSK’s Linerixibat GLISTENs In PBC Itching

 
• By Elizabeth Cairns

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...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Clinical Trials

Genentech Gets Columvi Complete Response Following ODAC’s No

 
• By Joseph Haas

Seeking to move Columvi into second-line DLBCL, Genentech got an FDA letter saying the Phase III STARGLO study’s benefits may have been driven by results in Asian enrollees.

BMS’s Reblozyl Misses Primary Endpoint In Myelofibrosis Anemia

 
• By Alaric DeArment

The drugmaker announced topline results from the Phase III INDEPENDENCE trial, which did meet key secondary endpoints.

AI-First, Big Pharma, Chinese Firms In Race - What’s Ahead For PRMT5 Inhibitors

 
• By Vibha Ravi

As AI-driven firms like Insilico, big pharma like J&J, Amgen, GSK and AstraZeneca and Chinese and Indian firms like BeOne and Dr. Reddy’s respectively advance PRMT5 inhibitor candidates, what’s driving interest, what could lead to the first global approval and what are the challenges ahead?

Actuate Is Looking For A Buyer To Advance Pancreatic Cancer Candidate

 
• By Jessica Merrill

After presenting encouraging Phase II data on the GSK-3 inhibitor elraglusib at ASCO, Actuate Therapeutics is hoping to hold a pre-NDA meeting with the US FDA.

More from Therapy Areas

BMS/Pfizer To Sell Discounted Eliquis Direct – And Other Drugmakers May Follow Suit

 
• By Alaric DeArment

Analysts see the new strategy as a way to address pressure from the Trump administration’s most favored nation drug pricing proposals.

Actuate Is Looking For A Buyer To Advance Pancreatic Cancer Candidate

 
• By Jessica Merrill

After presenting encouraging Phase II data on the GSK-3 inhibitor elraglusib at ASCO, Actuate Therapeutics is hoping to hold a pre-NDA meeting with the US FDA.

Novartis Upbeat Even With Entresto Expiry Looming

 
• By Kevin Grogan

Swiss major confident that new oncology drugs will fill revenue gap.