Three months on…..11 Jan 2026 12:55
As announced on 10 October 2025, the Company discontinued its 16-week GLP preclinical toxicology study for SDC-1801 following unexpected safety findings, observed by the third-party provider of the study. These findings occurred at a higher incidence in control-group animals that received an inactive dosing solution compared to those dosed with SDC-1801.
The Company has now appointed a different leading global CRO, with extensive experience in long-term toxicology studies, to restart the Phase 2-enabling toxicology programme. Prior to commencing the full 16-week toxicology study, the Company will conduct a separate pharmacokinetic (PK) study to evaluate four different formulations, three liquid formulations for gavage dosing and one capsule formulation. This five-day study will provide valuable data on both tolerability and exposure levels, helping to optimise the formulation selection for the full toxicology study. The carrier formulation is specific to the animal toxicology studies only and will not form part of any human dosing regimen.
The PK study is expected to commence imminently, with the full toxicology study expected to restart as early as possible in Q1 2026. Both studies will be completed using the Company's existing cash resources and the existing toxicology batch of SDC-1801.