RNS12 Mar 2026 07:09
RNS Number : 3116W Sareum Holdings PLC 12 March 2026
Sareum Holdings PLC ("Sareum" or the "Company")
Half-Year Report for the Six Months Ended 31 December 2025
Cambridge, UK, 12 March 2026 - Sareum Holdings plc (AIM: SAR), a clinical-stage biotechnology company developing next-generation kinase inhibitors for autoimmune disease and cancer, announces its unaudited results for the six months ended 31 December 2025.
Sareum also provides a broader update on operational activities and pipeline progress, highlighting the restart of the Phase 2-enabling toxicology programme for SDC-1801, its lead TYK2/JAK1 inhibitor being developed for a range of autoimmune diseases with an initial focus on psoriasis, following the successful completion of the Phase 1 clinical trial and a sufficient cash runway to advance the programme towards Phase 2 clinical development.
OPERATIONAL HIGHLIGHTS - INCLUDING POST-PERIOD UPDATES
SDC-1801 (autoimmune disease) · Strong Phase 1 data and continued positive momentum across the
TYK2/JAK1 field reinforce the Company's conviction that SDC‑1801 has the potential to become a differentiated, once‑daily oral therapy for autoimmune diseases. · Post-period, Sareum restarted the Phase 2-enabling toxicology programme for SDC-1801 with a leading global contract research organisation (CRO) with extensive experience in long-term toxicology studies. All subjects have commenced dosing. · Together with ongoing chemistry, manufacturing and controls (CMC) and formulation development activities, these efforts position SDC‑1801 for
Phase 2 clinical development, with psoriasis expected to serve as the initial proof‑of‑concept indication. · The restart followed discontinuation of the previous 16-week GLP study after unexpected findings were observed more frequently in control-group animals that did not receive SDC-1801 following safety findings observed by the third party provider of the study. Subsequent analysis confirmed the findings were unrelated to SDC-1801. · Ahead of the restart of the trial, the Company completed a short pharmacokinetic study to assess tolerability and exposure across different formulations, enabling selection of a suitable vehicle with precedent in long-term studies. · The toxicology programme is being conducted using the Company's existing cash resources and previously manufactured toxicology batch of
SDC-1801. The dosing phase is expected to complete in mid-2026, with the full
Phase 2-enabling regulatory package anticipated to be complete by year-end. · Work to optimise the capsule formulation of SDC-1801 is nearing completion, aimed at enhancing drug release at higher doses and reducing the number of capsules required per dose in future clinical trials. · The full dataset from the Phase 1 clinical trial, has been submitted to an academic journal and is currently undergoing peer review.
SDC-1802 (cancer immunotherapy) · Translational studies with SDC-1802 have been completed, providing a solid
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