Genentech announced mixed results from its phase 3 clinical program evaluating etrolizumab for the treatment of patients with moderately to severely active ulcerative colitis (UC).
Etrolizumab is an investigational humanized monoclonal anti-ß7 antibody designed to selectively inhibit α4β7 and αEβ7 integrins found on cells that play a key role in IBD. It is formulated as a once monthly subcutaneous injection.
The HIBISCUS I and II studies assessed etrolizumab for the induction of remission in patients without prior anti-tumor necrosis factor (TNF) treatment compared with adalimumab and placebo; the LAUREL study compared etrolizumab to placebo for the maintenance of remission in patients without prior anti-TNF treatment; and the HICKORY study compared etrolizumab to placebo for the induction and maintenance of remission in patients with prior anti-TNF treatment.
Findings from the HIBISCUS I study showed that etrolizumab met the primary end point for induction of remission, while the HIBISCUS II study did not meet its primary end point. In the HICKORY study, etrolizumab met the primary end point for induction but not maintenance, while in the LAUREL study, etrolizumab failed to meet the primary end point as maintenance therapy.
“We are disappointed with these results, because we know that people with ulcerative colitis need new treatment options,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development. “We are fully analyzing these data to learn more about how we might address the needs of people with this devastating disease.”
Genentech is also investigating etrolizumab for the treatment of patients with moderately to severely active Crohn disease with and without prior anti-TNF treatment in the phase 3 BERGAMOT study.
For more information visit gene.com.
Genentech provides update on phase III studies of etrolizumab in people with moderately to severely active ulcerative colitis. https://www.businesswire.com/news/home/20200809005022/en/Genentech-Update-Phase-III-Studies-Etrolizumab-People. Accessed August 11, 2020.