Sareum Completes Dosing in Phase 2-Enabling Toxicology Programme for TYK2/JAK1 Inhibitor SDC-1801
核心洞察
Sareum Holdings (搜索) has completed dosing in the Phase 2-enabling toxicology programme for SDC-1801, a selective oral TYK2 (搜索)/JAK1 (搜索) inhibitor, keeping the programme on track for year-end completion.
The toxicology programme builds on encouraging Phase 1 results published in the British Journal of Clinical Pharmacology, which demonstrated a well-tolerated safety profile and clear target engagement.
Phase 1 pharmacokinetic data showed a half-life of approximately 15–27 hours supporting once-daily oral dosing, with computational modelling indicating SDC-1801 at 70 mg twice-daily achieves exposure comparable to brepocitinib at 100 mg once-daily.
Sareum Holdings (搜索) plc (AIM: SAR), a clinical-stage biotechnology company developing next-generation kinase inhibitors for autoimmune disease and cancer, has announced the completion of dosing in its Phase 2-enabling toxicology programme for SDC-1801, a selective oral TYK2 (搜索)/JAK1 (搜索) inhibitor. The milestone, reported on 20 July 2026, keeps the programme firmly on track for completion by year-end, in line with the Company's expectations.
The toxicology programme was restarted in February 2026 and has progressed using the Company's existing cash resources. Sareum is now analysing the resulting data and pursuing necessary chemistry, manufacturing and controls (CMC) and formulation development activities, with the full Phase 2-enabling regulatory package anticipated by Q4 2026.
Dr John Reader, Chief Scientific Officer of Sareum, said: "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. We look forward to progressing the data analysis as we move closer to advancing SDC-1801 into the clinic for patients with autoimmune diseases."
Dr Stephen Parker, Executive Chairman of Sareum, added: "I am pleased to see the Phase 2-enabling toxicology programme completed on schedule, using existing cash resources and keeping us firmly on track towards our Phase 2-enabling milestones."
Phase 1 Clinical Data Published in Peer-Reviewed Journal
The toxicology programme builds upon comprehensive Phase 1 clinical data published in the British Journal of Clinical Pharmacology on 22 June 2026. The paper, titled "First-in-human, phase I, randomised, safety, pharmacokinetic, food-effect, and pharmacodynamic study of a tyrosine kinase 2/janus kinase 1 inhibitor, SDC-1801," presented findings from a randomised, double-blind, placebo-controlled study conducted in 95 healthy adult participants.
SDC-1801 was well tolerated across all doses tested, ranging from 5 mg to 150 mg, with no deaths and no treatment-related serious adverse events reported. Pharmacokinetic analysis demonstrated a half-life of approximately 15–27 hours, supporting once or twice-daily oral dosing.
Computational PK modelling revealed that SDC-1801 at 70 mg twice-daily achieved blood exposure levels comparable to brepocitinib, a clinically validated dual TYK2 (搜索)/JAK1 (搜索) inhibitor, at 100 mg once-daily — without the side effects observed with brepocitinib at this exposure level. Pharmacodynamic biomarker analysis provided evidence of sustained target engagement of both TYK2 and JAK1.
Dr John Reader commented on the publication: "The publication of the Phase 1 data in the British Journal of Clinical Pharmacology provides independent scientific validation of the strong clinical profile of SDC-1801, including good tolerability, a pharmacokinetic profile consistent with once-daily oral dosing, and clear evidence of target engagement through dose-dependent reductions in established inflammatory biomarkers."
He further noted: "These biomarker findings are predictive of SDC-1801's potential efficacy in patients and reinforce our confidence in SDC-1801's potential as a differentiated therapy for autoimmune diseases."
Formulation Optimisation and Next Steps
The PK data from the Phase 1 trial informed the ongoing Phase 2-enabling formulation programme, which aims to optimise the capsule to improve drug release at higher doses and reduce the capsule burden in future clinical trials. Both the formulation optimisation and the toxicology programme are being undertaken using the Company's existing cash resources.
SDC-1801 is being developed as a potential treatment for a range of autoimmune diseases, with an initial focus on psoriasis (搜索). Sareum is also advancing SDC-1802, a TYK2 (搜索)/JAK1 (搜索) inhibitor with potential application for certain haematological cancers, and has recently initiated a preclinical programme to develop TYK2/JAK1 inhibitors for neuroinflammatory diseases such as multiple sclerosis (搜索) and Parkinson's disease (搜索).