Sareum Holdings (AIM:SAR), the AIM-listed clinical-stage biotech developing kinase inhibitors for autoimmune disease and cancer, has completed dosing in the Phase 2-enabling toxicology programme for SDC-1801.
The drug is a selective oral TYK2/JAK1 inhibitor being developed for autoimmune diseases, with an initial focus on psoriasis.
The programme, restarted in February 2026, has progressed in line with the company's expectations.
Sareum is now analysing the resulting data and advancing chemistry, manufacturing and controls (CMC) and formulation work, targeting completion of the full Phase 2-enabling regulatory package by the fourth quarter.
The company said the work has been funded using existing cash resources.
"The completion of dosing in this toxicology programme is an important milestone towards completing the full Phase 2-enabling regulatory package, building on the encouraging Phase 1 results, which showed a pharmacokinetic profile consistent with once-daily dosing and no safety concerns," said Dr John Reader, Sareum's Chief Scientific Officer.
Executive Chairman Dr Stephen Parker said the programme's on-schedule completion keeps the company "firmly on track" towards its Phase 2-enabling milestones.
Sareum is targeting completion of the full regulatory package by the end of the fourth quarter.
News Intelligence what this means for the company
Sareum has completed dosing in the Phase 2-enabling toxicology study for SDC-1801, its lead psoriasis candidate, and is now analysing the data while advancing manufacturing and formulation work toward a year-end regulatory submission. The milestone keeps the company on its stated timeline; Phase 1 results showed a pharmacokinetic profile consistent with once-daily dosing and no safety concerns, and toxicology completion removes a near-term binary risk on the path to Phase 2.
Sareum remains a clinical-stage biotech dependent on execution of its regulatory package by end-Q4 2026. Toxicology completion is a necessary step, not a value inflection—the company's valuation hinges on whether the full package clears regulatory review and Phase 2 data eventually supports the TYK2/JAK1 thesis in psoriasis.
Insights assembled by AI. Editor-reviewed and grounded in tickstock’s coverage and proprietary knowledge graph.
Content is for informational purposes only, not financial advice.
