Sareum Regulatory News (SAR)

 Sareum Holdings PLC

("Sareum" or the "Company")

Sareum starts dosing first subjects in the multiple ascending dose part of Phase 1a clinical trial for SDC-1801

Cambridge, UK, 4th September 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 the multiple ascending dose part of its Phase 1a clinical trial for lead programme SDC-1801. Dosing has started at a specialist clinical unit in Melbourne, Australia, and subjects will receive SDC-1801 orally once daily for 10 days.

This follows approval by the safety review committee granted upon review of preliminary data generated from the initial three cohorts in the single ascending dose part of the study. The committee deemed these data as satisfactory for the multiple ascending dose part of the study to commence, as well as for continued dose escalation in the single ascending dose part of the study.

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).

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.

Dr Tim Mitchell, CEO of Sareum, commented:

"We are delighted that the data generated to date supports the safety review committee's approval to begin dosing the first subjects in the multiple ascending dose part of our Phase 1a trial of SDC-1801. Of particular importance are the pharmacokinetics findings demonstrating that patients will be able to receive SDC-1801 orally once daily. During this next phase of the study, we expect valuable biomarker data to be generated, that will be available upon completion of this part of the trial.

"As SDC-1801 continues to progress through the clinic on schedule, we remain committed to bringing this innovative medicine to patients with autoimmune disease. We look forward to the completion of the Phase 1a study and to progression into Phase 1b, subject to continuing positive safety results in the remainder of the Phase 1a."

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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