Zura Bio's skin disease drug fails mid-stage trial

By Reuters News

- Zura Bio ZURA.O said on Monday its experimental drug failed the main goal of a mid-stage study in patients with hidradenitis suppurativa, a chronic skin disease that causes painful lumps under the skin.

Shares of the biotech firm fell more than 70% in premarket trading.


  • The company said tibulizumab failed the study's main goal of showing a benefit over placebo in reducing abscesses and inflammatory skin nodules after 16 weeks

  • Key secondary goals were also missed, including measures tracking the proportion of patients achieving at least 50% and 75% reductions in disease lesions

  • Zura said it will discontinue tibulizumab's development for hidradenitis suppurativa but continue studying it in systemic sclerosis, which can cause hardens the skin and organs, and polymyalgia rheumatica, an inflammatory condition causing muscle pain and stiffness

  • The trial enrolled 247 adults with moderate-to-severe hidradenitis suppurativa who were randomly assigned to receive one of two doses of tibulizumab or placebo

  • The two tibulizumab doses reduced lesion counts by 56% and 58.1%, respectively, versus a 52.5% reduction in the placebo group, the company said

  • It added the drug was well tolerated, while one death in the higher-dose group was considered unrelated to treatment by the study investigator

  • Zura said it had $187.7 million in cash and cash equivalents as of September 30, which it expects will support planned operations through at least the end of 2028

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