Sareum Holdings (AIM:SAR), an AIM-listed clinical-stage biotechnology company developing kinase inhibitors for autoimmune disease and cancer, has published the complete Phase 1 dataset for its lead asset SDC-1801 in the British Journal of Clinical Pharmacology.
The randomised, double-blind, placebo-controlled study enrolled 95 healthy adults and tested doses from 5mg to 150mg, with no deaths and no treatment-related serious adverse events recorded across the range.
Pharmacokinetic analysis showed a half-life of approximately 15 to 27 hours, supporting once or twice-daily oral dosing.
Computational modelling indicated that SDC-1801 at 70mg twice-daily achieved blood exposure comparable to brepocitinib, a clinically validated dual TYK2/JAK1 inhibitor, at 100mg once-daily, without the side effects observed at that exposure level.
Biomarker analysis showed sustained engagement of both TYK2 and JAK1 targets, providing evidence of potential efficacy in patients.
The pharmacokinetic data are informing an ongoing formulation programme aimed at improving drug release at higher doses and reducing capsule burden in future trials, funded from existing cash resources.
"The publication 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," said Dr John Reader, Chief Scientific Officer.
A complete Phase 2-enabling regulatory package is anticipated by year-end.
