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RAPT Therapeutics’ Lead Drug On Clinical Hold After Case Of Liver Failure

Cause Unknown; May Be Linked To Supplement

 
• By Mandy Jackson

Zelnecirnon (RPT193), in Phase IIb for atopic dermatitis and Phase IIa for asthma, may not have caused the case of liver failure cited in the hold but the pause may impede a crucial data readout.

Face the accumulated contradictions. Blocking further action. Pause and reevaluate the situation.
RAPT's atopic dermatitis trial was halted months before a planned topline readout • Source: Shutterstock

RAPT Therapeutics, Inc. plans to work as fast as it can to resolve a clinical hold the US Food and Drug Administration placed on trials of its CCR4 antagonist zelnecirnon (RPT193) after a serious adverse event of liver failure in a Phase IIb atopic dermatitis study. However, it is unclear whether the hold can be lifted quickly enough to maintain the integrity of data from the AD trial and a Phase IIa asthma study and keep the company from having to initiate all new trials.

Key Takeaways

  • The US FDA placed a clinical hold on RAPT’s trials of CCR4 antagonist zelnecirnon (RPT193) in atopic dermatitis (AD) and asthma after a serious adverse event of liver failure.

  • The patient had a complicated medical history, including COVID-19 at the time of liver failure and use of an herbal supplement known to cause liver failure, but more information is needed

Announcing the clinical hold on 20 February, South San Francisco-based RAPT said it received only verbal notification from the FDA about the hold, so information about the liver failure event is limited until the company receives written communication from the agency

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Pipeline Watch: Thirteen Approvals And Ten Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.