Sareum halts toxicology study after control-group safety findings

(Sharecast News) - Clinical-stage biotechnology firm Sareum said on Friday that it has discontinued its 16-week pre-clinical toxicology study for autoimmune and cancer candidate SDC-1801 after safety issues were flagged by a third-party provider.

The AIM-listed firm said dosing had been terminated and the study would be formally closed following final analysis. A preliminary review suggests the issues were "highly unlikely to be related to SDC-1801", with Sareum now working with consultants to determine next steps.

Sareum stated the findings were observed more frequently in control-group animals given an inactive solution than in those dosed with SDC-1801.

The study was intended to support longer-term dosing ahead of a planned Phase 2 trial in psoriasis, with Sareum now in talks with alternative providers to restart the study.

Sareum reiterated that its Phase 1 trial in healthy volunteers met all primary objectives, with no safety concerns identified and a pharmacokinetic profile consistent with once-daily dosing.

Executive chairman Dr Stephen Parker said: "While the need to terminate this study is frustrating, the preliminary data strongly suggest that the findings are unlikely to be associated with SDC-1801.

"Dosing has been terminated out of concern for animal welfare, and we are working closely with our partners and experts to understand the cause and identify a new provider with the aim of restarting the study as quickly as possible with our existing cash resources."

As of 0930 BST, Sareum shares had sunk 29.65% to 14p.

Reporting by Iain Gilbert at Sharecast.com