|
Sareum Holdings PLC on Friday said it has ended a study of its drug SDC-1801 after safety issues observed in animals involved in the study. Sareum is a Cambridge, England-based pharmaceutical company focused on developing next-generation kinase inhibitors for autoimmune disease and cancer. Shares in Sareum sank 22% to 15.60 pence in London on Friday morning. The safety findings were observed during the 16-week preclinical toxicology study. The issues were found at a higher incidence in the control-group animals which were given an inactive dosing solution compared to those that were actually dosed with SDC-1801, Sareum noted. Dosing has now been terminated, and the study will be formally closed after scheduled analyses and reporting activities. Sareum said the study was designed to support longer-term dosing of SDC-1801 and to investigate its general toxicology. The firm said these are key regulatory requirements ahead of the planned phase two clinical development programme, which is expected to focus initially on psoriasis. Based on the information available, the safety findings are ‘highly unlikely’ to be related to SDC-1801, Sareum noted. The firm is reviewing the data with the contractor and consultants to determine the cause of the findings and the appropriate next steps. Sareum said it is in discussions with alternate providers to try to restart the study as soon as possible. It expects to be able to complete the full toxicology study, as originally scoped, with its existing cash resources. As previously reported, the phase one clinical study of SDC-1801 in healthy volunteers met its primary objectives, and no safety concerns were identified. ‘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,’ said Executive Chair Stephen Parker. ‘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.’ Copyright 2025 Alliance News Ltd. All Rights Reserved.
|
