Sareum says so long to SAD and hi to happy as trials hurdle is cleared

Sareum CEO Tim Mitchell saw the share price rise encouragingly on completion of the single ascending dose (SAD) part and the food effect study of the trial which marks continued progress for SDC-1801.

AIM-quoted Sareum is a clinical-stage biotechnology company developing next generation kinase inhibitors for autoimmune disease and cancer. 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.

This is a randomised, placebo-controlled trial with single and multiple ascending oral dose studies. It 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.

Dr Mitchell said: “We're pleased to announce that Sareum has cleared an important milestone in this trial. We are encouraged by the preliminary data from the SAD and food effect parts of the Phase 1a trial for SDC-1801, which support our confidence in the trial and the broader clinical strategy.

“These are preliminary results but if we continue to see the positive safety profile and pharmacokinetic data we have seen so far, this will underpin our planning for the Phase 1b part of the study and beyond.

“We look forward to the data from the multiple ascending dose part of this trial, which will help us advance towards this critical next point in the study.”