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...

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

New CTIS Feature To Bridge ‘Communication Gap’ Between Trial Sponsors & EU Assessors

 
• By 

A task force set up by the EMA to identify and prioritize improvements to the Clinical Trials Information System has recommended several measures to enhance CTIS’ usability and efficiency, including the potential introduction of a communication tool for direct sponsor-assessor interaction.

Australia Targets Clinical Trial Reform, AI Use And Drug Shortages In 12-Month Plan

 

Reforming clinical trial regulations, addressing the use of artificial intelligence, mitigating medicines shortages and strengthening ties with other drug regulators are key priorities for Australia’s Therapeutic Goods Administration over the next year.

EU’s Life Sciences Strategy Faces Race Against Time, Says Clinical Trials Community

 
• By 

The report gave examples of missed opportunities for innovation and patient access, as well as regulatory and operational problems that undermine the conduct of timely clinical trials in Europe.

Sponsors Asked, EMA Delivered: One Handbook To Navigate CTIS

 
• By 

The European Medicines Agency has revised the sponsor handbook for the Clinical Trials Information System, bringing together guidance that was previously scattered across multiple platforms and documents to help sponsors navigate the trial process more efficiently.

More from R&D

Sarepta Refuses To Stop Elevidys Shipments After Third Death Linked To Gene Therapy Vector

 
• By 

Sarepta knew about the death in a Phase I trial of SRP-9004 for LGMD when it recently revealed a restructuring plan, but did not disclose the event. The now-discontinued gene therapy candidate uses the same AAV vector as Elevidys, which has been linked to two DMD patient deaths.

UK HRA Sets Targets For Digital Overhaul, Trial Transparency And Trust

 
• By 

The UK Health Research Authority’s latest three-year strategy sets ambitious targets to make research more transparent. One World Health Organization official believes the authority can go further by setting equally high standards for the timely reporting of clinical trial results.

Otsuka/Lundbeck’s Rexulti PTSD Claim Will Test US FDA AdComm’s Supportive Evidence Flexibility

 

Rexulti’s post-traumatic stress disorder sNDA tries to make up for a failed Phase III study by placing a Phase II study into a key evidentiary role, raising questions for the July 18 advisory committee meeting about assessing discordant results and post-hoc analyses.