Sareum Holdings plc announced the completion of the single ascending dose (SAD) part and the food effect study of its Phase 1a clinical trial for the lead programme SDC-1801. 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. 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). Dosing of the final subjects in the SAD part of the trial has now concluded and the safety review committee for the trial has reviewed available data.

The SAD study randomised participants in a 3:1 ratio to a single dose of SDC-1801 or placebo in six dose cohorts. Preliminary blinded safety, tolerability and pharmacokinetics data from the trial indicate a favourable profile and support oral dosing of patients once daily. These preliminary results indicate that SDC-1801 has the potential to achieve therapeutically effective dose levels with no serious adverse events.

The food effect study part of the trial has also been completed. The results of this study demonstrated no significant food effect on SDC-1801 blood levels, which will allow full flexibility in dose timing in future clinical studies. The multiple ascending dose study is ongoing and full safety data from the Phase 1a clinical trial are expected to be available during the first half of 2024.

If the results are satisfactory and subject to financing, regulatory requirements, and recruitment preparations, the Company plans to initiate a Phase 1b clinical study. The goal is to recruit up to 24 psoriasis patients, with the study expected to be completed by the end of 2024.