Urticaria Drug Candidate Succeeds in Phase 2, Outperforming Xolair

Cue Biopharma’s urticaria drug candidate met its primary endpoint in a Phase 2 trial, producing results that surpassed those of the existing treatment Xolair.

According to Fierce Biotech, a US biotechnology news outlet, on the 21st local time, Cue Biopharma achieved the primary endpoint in a Phase 2 trial of CUE-221, a candidate treatment for chronic spontaneous urticaria (CSU).

The trial was conducted in China and enrolled 145 participants. Participants received subcutaneous injections of one of three CUE-221 dose levels or placebo at 4-week intervals.

At week 12, the proportion of participants whose urticaria had completely cleared was 43% to 54% in the CUE-221 groups, based on the HSS7 scale. The rate was 11% in the placebo group.

Complete-clearance rates for all CUE-221 dose groups were statistically significant compared with placebo. The clearance rate in the Xolair comparator group was 41%, meaning the CUE-221 groups were numerically superior.

A similar pattern was observed for secondary endpoints. Based on the UAS7 scale, complete response rates were 38% to 46% in the CUE-221 groups, compared with 11% and 29% in the placebo and Xolair groups, respectively.

Responses deepened after week 12. Investigators administered the final dose at week 16 and followed participants through week 28. The effect of CUE-221 peaked at week 22, when the HSS7 clearance rate reached as high as 69%, compared with 41% in the Xolair group.

The gap widened further at week 28. The response rate in the high-dose CUE-221 group was 60%, substantially higher than the 24% rate in the Xolair group. However, the response rates in the two low-dose groups were 31% and 24%, respectively.

Cue Biopharma said the difference in response rates at week 28 supports the view that its drug has a fundamentally different effect on the biology of the disease. Like Xolair, CUE-221 is designed to neutralize free IgE, but the company said it also downregulates IgE production, inducing deeper and more durable disease control.

Based on these data, Cue Biopharma plans to begin a Phase 2b/3 trial in CSU. The company is also preparing a Phase 2 trial in food allergy. Cue Biopharma raised $50 million in July and currently has at least 12 months of cash on hand.