Does Bristol Nuc’s Possible Cardiac Toxicity Portend A Class Effect?

Bristol-Myers Squibb has halted study of its Phase II nucleoside polymerase inhibitor for hepatitis C due to one trial patient suffering heart failure. It remains unclear if that event is related to the study drug, but do repeated toxicity issues with “nucs” indicate a class effect?

Of seven nucleoside polymerase inhibitors (aka “nucs”) that have reached Phase II in development for hepatitis C, five have faced significant safety hurdles, with Bristol-Myers Squibb Co.’s halt of a Phase II trial for its nuc, BMS-986094, due to a trial participant suffering heart failure just the latest occurrence. While Bristol has stopped dosing in that trial to review relevant patient data to ascertain a possibly safety risk with BMS094, some Wall Street analysts are wondering whether there is a class-wide safety issue with nucs.

Prior to Bristol’s Aug. 1 announcement, nucs such as Roche’s R1626, Novartis AG and Idenix Pharmaceuticals Inc.’s NM283, Idenix’s IDX184 and Pharmasset Inc.’s PSI-938 all had...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet 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

More from Clinical Trials

US FDA’s Prasad: ‘We Will Always Embrace Surrogate Endpoints’

 

The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.

UK And US Regulators In Sync On RWD External Control Arms

 
• By 

The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.

EU To Track Decentralized Clinical Trials In CTIS To Support Innovation

 
• By 

Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.

More from R&D

EU To Track Decentralized Clinical Trials In CTIS To Support Innovation

 
• By 

Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.

Pink Sheet Podcast: US FDA’s Big Vaccine Policy Week

Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
• By 

The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.