Sareum Halts SDC-1801 Toxicology Study Due to Animal Welfare Concerns, Phase 2 Psoriasis Trial Delayed
核心洞察
Sareum Holdings terminated a 16-week preclinical toxicology study of kinase (搜索) inhibitor SDC-1801 after observing safety issues in test animals, though the problems occurred more frequently in control animals than those receiving the drug.
The company's shares fell 22% to 15.60 pence following the announcement, as the halted study was required for regulatory approval of the planned phase 2 clinical program targeting psoriasis (搜索).
Sareum maintains the safety findings are "highly unlikely" to be related to SDC-1801 and is working with alternate providers to restart the study using existing cash resources.
Sareum Holdings PLC (搜索) terminated a critical preclinical toxicology study of its kinase (搜索) inhibitor SDC-1801 after observing safety issues in test animals, forcing the Cambridge-based pharmaceutical company to delay its planned phase 2 clinical development program for psoriasis (搜索). The company's shares plummeted 22% to 15.60 pence in London trading following the announcement.
Study Termination Details
The safety findings emerged during a 16-week preclinical toxicology study designed to support longer-term dosing of SDC-1801 and investigate its general toxicology profile. Notably, the safety issues occurred at a higher incidence in control-group animals that received an inactive dosing solution compared to those actually dosed 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," said Executive Chair Stephen Parker.
Regulatory Implications
The halted study represents a key regulatory requirement for Sareum's planned phase 2 clinical development program, which was expected to focus initially on psoriasis (搜索) treatment. The company develops next-generation kinase (搜索) inhibitors for autoimmune diseases and cancer (搜索).
Based on available information, Sareum maintains that the safety findings are "highly unlikely" to be related to SDC-1801. The company is reviewing data with contractors and consultants to determine the cause of the findings and appropriate next steps.
Previous Clinical Success
The setback contrasts with earlier positive results from SDC-1801's development program. The phase 1 clinical study in healthy volunteers met its primary objectives with no safety concerns identified, providing a foundation for the company's confidence that the current issues are unrelated to the drug candidate.
Path Forward
Sareum is in discussions with alternate providers to restart the toxicology study as soon as possible. The company expects to complete the full toxicology study as originally scoped using existing cash resources, indicating sufficient funding remains available despite the delay.
"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," Parker noted, emphasizing the company's commitment to resolving the situation and advancing the drug candidate toward clinical trials.