Initiation of food effects study for SDC-1801

Cambridge, UK, 9 November 2023 - Sareum Holdings plc (AIM: SAR), a biotechnology company developing next generation kinase inhibitors for autoimmune disease and cancer, today announces the dosing of the first subjects in the food effects part of its Phase 1a clinical trial of lead programme SDC-1801. Dosing has started at a specialist clinical unit in Melbourne, Australia.

The food effects study is a key part of the Phase 1a trial, designed to determine how the presence of food might affect the absorption and pharmacokinetic profile of SDC-1801. This part of the study will inform whether the drug should be taken with food or on an empty stomach, optimising its potential benefits whilst potentially minimising any possible side effects. This study runs in conjunction with the Single Ascending Dose (SAD) and the Multiple Ascending Dose (MAD) parts of the trial, which are concurrently dosing subjects as planned, ensuring a robust assessment of SDC-1801's pharmacological profile.

SDC-1801 is a dual TYK2/JAK1 kinase inhibitor being developed as a potential new therapeutic for a range of autoimmune diseases with an initial focus on psoriasis, an autoimmune condition affecting the skin.

Full safety data from the Phase 1a trial are expected to be available during the first half of 2024 and, provided satisfactory results are obtained, a Phase 1b clinical study is expected to commence as soon as possible thereafter in psoriasis patients.

Dr Tim Mitchell, CEO of Sareum, commented: "The food effects study will provide key information about the absorption of SDC-1801 in fed or fasted healthy subjects, and forms an essential part of the safety data we are compiling which will support the next stages of development. This is another important milestone in our clinical development.

"We are pleased with the continued positive progress made in this trial and look forward to obtaining full safety data in the first half of 2024."

About the Phase 1a trial of SDC-1801

The Phase 1a trial is designed to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of an oral formulation of SDC-1801 in healthy subjects (trial ID ACTRN12623000416695p). This is a randomised, placebo-controlled trial with single and multiple ascending oral dose studies. This trial includes a single ascending dose study (Part 1), a multiple ascending dose study (Part 2) and a food effects study (Part 3).

The safety and pharmacokinetics data from the initial cohorts in Part 1 of the trial indicate a favourable profile and fully support oral dosing of patients once daily. Full safety data from the Phase 1a trial are expected to be available during the first half of 2024 and, provided satisfactory results are obtained, a Phase 1b clinical study is expected to commence as soon as possible thereafter in psoriasis patients.