Sareum Regulatory News (SAR)

 Sareum Holdings PLC

("Sareum" or the "Company")

Update on SDC-1801 Clinical Trial Progress

- Sareum completes dosing in the single ascending dose (SAD) part and the food effect study of Phase 1a clinical trial for SDC-1801

- Preliminary results indicate the potential of SDC-1801 to achieve therapeutically effective dose levels with no serious adverse events

Cambridge, UK, 15 February 2024 - Sareum Holdings plc (AIM: SAR), a clinical-stage biotechnology company developing next generation kinase inhibitors for autoimmune disease and cancer, today announces 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.

Dr Tim Mitchell, CEO of Sareum, commented: "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."

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The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulation (EU) No. 596/2014 as it forms part of United Kingdom domestic law by virtue of the European Union (Withdrawal) Act 2018, as amended by virtue of the Market Abuse (Amendment) (EU Exit) Regulations 2019 ("UK MAR").

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 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