Sareum Regulatory News (SAR)

 Sareum Holdings PLC

("Sareum" or the "Company")

Sareum announces dosing of first subjects in Phase 1a clinical trial for SDC-1801

Cambridge, UK, 6th June 2023 - Sareum Holdings plc (AIM: SAR), a clinical-stage biotechnology company developing next generation kinase inhibitors for autoimmune disease and cancer, today announces the successful dosing of the first subjects in a Phase 1a clinical trial for its lead programme SDC-1801. The dosing has started at a specialist clinical unit in Melbourne, Australia.

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 will be a randomised, placebo-controlled trial with single and multiple ascending oral dose studies.

Full safety data from this 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:

"We are delighted to begin dosing the first subjects in our Phase 1a trial of SDC-1801. Dual TYK2 and JAK1 inhibition offers significant potential benefits for immune health and we believe by targeting both these pathways, SDC-1801 could have the potential for superior efficacy in autoimmune disease compared to agents that block just one of the two kinases.

"Dosing of the first subjects in this trial is an important first step to establishing the safety and tolerability profile of SDC-1801 and we look forward to watching the trial progress."

Further Information on the Phase 1a Trial of SDC-1801

The phase 1a trial includes a single ascending dose study (Part 1), a multiple ascending dose study (Part 2) and a food effects study (Part 3). Part 1 will consist of at least 6 sequential, ascending dose cohorts of 8 subjects each (total of 48 subjects) randomised to receive SDC-1801 or matched placebo in a 3:1 ratio. Each subject will be in Part 1 for approximately 6 weeks (screening visit to follow-up visit). Part 2 (multiple ascending dose) is planned to commence after the Safety Review Committee (SRC) has evaluated the available data from at least Cohorts A, B, and C in Part 1.

The multiple ascending dose part of the trial will consist of at least 4 sequential, ascending doses of SDC-1801 or matched placebo cohorts (cohorts A to D). Each cohort in Part 2 will consist of 8 subjects (a total of 32 subjects). Each subject will be in the study for approximately 8 weeks. Part 3 of the study is expected to run in parallel with Part 2, and will examine how food affects the absorption of SDC-1801.

The Company expects to provide a further update on the trial once initial safety and pharmacokinetic data observed in the single ascending dose study provide sufficient support for progression to Part 2 of the study, expected in H2 2023.

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About Sareum

Sareum Holdings (AIM:SAR) is a clinical-stage biotechnology company developing next generation kinase inhibitors for autoimmune disease and cancer.

The Company is focused on developing next generation small molecules which modify the activity of the JAK kinase family and have best-in-class potential. Its lead candidate, SDC-1801, simultaneously inhibits TYK2 and JAK1. SDC-1801 is a potential treatment for a range of autoimmune diseases and has entered Phase 1a/b clinical development with an initial focus on psoriasis.

Sareum has an economic interest in SRA737, a clinical-stage Chk1 inhibitor which it originally developed in collaboration with several Cancer Research UK-related organisations. SRA737 has shown promising safety and efficacy in two Phase 1/2 clinical trials.

Sareum is also developing SDC-1802, a TYK2/JAK1 inhibitor with a potential application for cancer immunotherapy.

Sareum Holdings plc is based in Cambridge, UK, and is listed on the AIM market of the London Stock Exchange, trading under the ticker SAR. For further information, please visit the Company's website at www.sareum.com