Zura Bio discontinues tibulizumab development in hidradenitis suppurativa after Phase II miss

Zura Bio has reported that its Phase II TibuSHIELD study of tibulizumab in moderate-to-severe hidradenitis suppurativa did not meet its primary or key secondary efficacy endpoints.

Following the results, the company will discontinue development of tibulizumab in hidradenitis suppurativa.

The global, randomised, double-blind, placebo-controlled study enrolled 247 adults and evaluated two doses of tibulizumab, 300 mg and 150 mg, against placebo.

The primary endpoint measured the percentage change from baseline in total abscess and inflammatory nodule count at Week 16.

Patients receiving tibulizumab 300 mg recorded a 56.0% reduction in abscess and inflammatory nodule count, while the 150 mg group achieved a 58.1% reduction.

The placebo group recorded a 52.5% reduction.

The differences were not sufficient for the study to meet its primary endpoint.

Key secondary endpoints were also not achieved.

HiSCR50 response rates were 48.0% with tibulizumab 300 mg and 52.7% with the 150 mg dose, compared with 45.5% for placebo.

HiSCR75 response rates were 35.3% and 34.0% in the two tibulizumab groups respectively, compared with 28.1% in the placebo group.

Zura said it is conducting additional analyses to better understand the study findings, including pharmacokinetic and pharmacodynamic assessments, exposure-response relationships and hidradenitis suppurativa-specific factors.

Sandeep Kulkarni, MD, Chief Executive Officer of Zura Bio, said the results highlight the challenges of developing therapies in hidradenitis suppurativa, including variability in placebo responses.

He said the company will continue investigating dual IL-17 and BAFF inhibition in other autoimmune diseases with different underlying biology.

Tibulizumab was reported to be generally well tolerated, with the observed safety profile consistent with established experience for IL-17 and BAFF inhibition.

Treatment-emergent adverse events were reported in 52.4% of patients in each tibulizumab arm, compared with 46.3% of patients receiving placebo.

Serious treatment-emergent adverse events occurred in 6.1% of patients in the 300 mg group, 3.7% in the 150 mg group and 1.2% in the placebo group.

One treatment-related serious adverse event was reported in the 300 mg arm.

One death due to cardiac arrest occurred in a participant receiving tibulizumab 300 mg, but the site investigator determined that it was unrelated to study treatment.

One adverse event of special interest was also reported, involving an exacerbation of pre-existing inflammatory bowel disease in a patient receiving the 300 mg dose.

Despite ending development in hidradenitis suppurativa, Zura will continue evaluating tibulizumab in systemic sclerosis and polymyalgia rheumatica.

Topline results from the ongoing TibuSURE systemic sclerosis study are expected in the first half of 2027.

The company also plans to begin the NEXUS-PMR study in polymyalgia rheumatica, with data expected in the fourth quarter of 2028.

As of September 30, 2026, Zura reported cash and cash equivalents of $187.7 million and expects its existing resources to support planned operations through at least the end of 2028.

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Related Topics and Keywords

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