Surrozen pauses PhI clinical trial in ulcerative colitis due to adverse events in liver

15 Nov 2022
endpts.com
Phase 1
Just over a month after Wnt player Surrozen handed off its retinal disease candidate to Boehringer Ingelheim, the San Francisco biotech is reporting clinical issues on its end. Per a Q3 report released Monday afternoon, Surrozen has decided to pause enrollment in the ascending dose portion of a Phase I trial, which was testing candidate SZN-1326 in patients with ulcerative colitis. As for why, the biotech said it observed “treatment-related adverse events,” with several subjects experiencing “asymptomatic liver transaminase elevations,” including three subjects with grade 3 elevations of aspartate transaminase (AST) and alanine transaminase (ALT). Elevated levels of either of these enzymes are potential indicators of liver damage or liver disease. The biotech added in its statement: Surrozen added that its next steps are to analyze all the clinical data with the study investigator and conduct preclinical experiments to pin down why transaminase levels were elevated, noting that increased levels of transaminase were not observed in GLP-toxiciology studies. After that, Surrozen will determine next steps for the program. A Surrozen spokesperson told Endpoints News that the biotech does not have any comment beyond its press release. Shares of Surrozen $SRZN went down about a handful of cents as of Tuesday morning to $1.74, riding toward penny stock territory. The biotech started the year off at over $6 a share, now down almost 70% since January 1. This is the newest update for the 94-employee biotech after it secured a deal with Boehringer Ingelheim in October for a Fzd4-targeted bispecific antibody candidate for retinal diseases and two backups for $12.5 million upfront. If Boehringer brings the candidate to market, Surrozen is up for an additional $586.5 million in milestones plus royalties. What makes Surrozen stand out is its work attempting to modulate the Wnt pathway, which plays a role in stem cells and tissue integrity. Surrozen had been investigating the pathway specifically for tissue injury and to try to regenerate tissue. CEO Craig Parker told Endpoints News at the time of the deal with Boehringer that one of the reasons the Wnt pathway has been historically difficult to target is primarily a biochemistry issue, especially when it comes to recombinant proteins. While researchers can make insulin or growth hormones or erythropoietin to replace something missing, a recombinant Wnt protein isn’t quite in the cards due to the interaction between the protein and the receptor.
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