Restart of Phase 2-enabling toxicology programme
Sareum Holdings PLC has restarted the Phase 2-enabling toxicology programme for its selective TYK2/JAK1 inhibitor, SDC-1801, which is being developed for autoimmune diseases like psoriasis. This programme, being conducted by a global contract research organisation using existing cash resources and toxicology batch, is expected to complete its dosing phase by mid-2026 and the full Phase 2-enabling package by year-end, following preliminary pharmacokinetic work. The company is confident that this, combined with positive Phase 1 data, will support SDC-1801's advancement as a potential best-in-class, once-daily oral therapy.
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Cambridge, UK, 17 February 2026 - Sareum Holdings plc (AIM: SAR), a clinical-stage biotechnology company developing next-generation kinase inhibitors for autoimmune disease and cancer, is pleased to announce that it has restarted the Phase 2-enabling toxicology programme for SDC-1801, a selective TYK2/JAK1 inhibitor being developed as a potential treatment for a range of autoimmune diseases, with an initial focus on psoriasis.
The Company has appointed a leading global contract research organisation (CRO), with extensive experience in long-term toxicology studies to conduct the programme following the discontinuation of a previous study, as announced on 10 October 2025.
Before restarting, the Company completed preliminary pharmacokinetic (PK) work to evaluate tolerability and exposure levels across different formulations allowing selection of a vehicle with some precedence in long-term studies.
The toxicology programme is being conducted using the Company's existing cash resources and toxicology batch of SDC-1801. Completion of this programme, together with ongoing CMC and formulation development activities, will form the Phase 2-enabling regulatory package, positioning the programme for Phase 2 clinical development. The dosing phase of the toxicology studies is expected to complete in mid-2026, with the full Phase 2-enabling package expected to be complete by year-end.
As previously reported, the Phase 1 clinical study of SDC-1801 in healthy volunteers met its primary objectives and characterised a pharmacokinetic profile consistent with once-daily dosing. No safety concerns were identified.
Dr Stephen Parker, Executive Chairman of Sareum, said: "Generating a full Phase 2 enabling toxicology package is an important step forward for SDC-1801. The appointment of an experienced global CRO and the successful completion of the preliminary PK study give us confidence as we advance through this important phase of development. Combined with the strong Phase 1 data, these studies will further support SDC-1801's potential to become a best-in-class, once-daily oral therapy for autoimmune diseases. We look forward to providing further updates as the programme progresses."
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