REG - Sareum Holdings PLC - Update on toxicology study for SDC-1801

Sareum HoldingsAnnouncement

10/10/2025 07:00

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RNS Number : 8192C  Sareum Holdings PLC  10 October 2025

 

Sareum Holdings PLC

 

("Sareum" or the "Company")

Update on toxicology study for SDC-1801

Cambridge, UK, 10 October 2025 - Sareum Holdings plc (AIM: SAR), a
clinical-stage biotechnology company developing next-generation kinase
inhibitors for autoimmune disease and cancer, announces that it has
discontinued its 16-week GLP preclinical toxicology study for SDC-1801
following safety findings observed by the third-party provider of the study.
The safety issues were encountered at a higher incidence in the control-group
animals which were given an inactive dosing solution compared to those that
were actually dosed with SDC-1801. Accordingly, dosing has now been
terminated, and the study will be formally closed following completion of
scheduled analyses and reporting activities.

The study was designed to support longer-term dosing of SDC-1801 and to
investigate the molecule's general toxicology. These are key regulatory
requirements ahead of the planned Phase 2 clinical development programme,
which is expected to focus initially on psoriasis.

A preliminary assessment of the available data indicates that the findings
observed during the study were disproportionately present in control-group
animals which were not treated with SDC-1801, and based on the information
available, are therefore considered highly unlikely to be related to SDC-1801.
Sareum is reviewing the study data with the contractor and expert consultants
to determine the cause of the findings and the appropriate next steps.

The Company is also in discussions with alternative providers with the aim of
restarting the study as soon as possible. Despite this set back, the Company
anticipates being able to complete the full toxicology study, as originally
scoped, with its existing cash resources.

As previously reported, the Phase 1 clinical study of SDC-1801 in healthy
volunteers met its primary objectives and characterised a pharmacokinetic
profile consistent with once-daily dosing. No safety concerns were identified.

Dr Stephen Parker, Executive Chairman of Sareum, said: "While the need to
terminate this study is frustrating, the preliminary data strongly suggest
that the findings are unlikely to be associated with SDC-1801. Dosing has been
terminated out of concern for animal welfare, and we are working closely with
our partners and experts to understand the cause and identify a new provider
with the aim of restarting the study as quickly as possible with our existing
cash resources."

Sareum will provide a further update at the earliest possible opportunity once
the review is complete.

- Ends -

 

For further information:

 

 Sareum Holdings plc

 Stephen Parker, Executive Chairman         01223 497700

                                            ir@sareum.co.uk
 Strand Hanson Limited (Nominated Adviser)

 James Dance / James Bellman                020 7409 3494

 Oberon Capital (Broker)

 Mike Seabrook / Nick Lovering              020 3179 5300

 ICR Healthcare (Financial PR)

 Jessica Hodgson / Davide Salvi             020 3709 5700

 

 

About Sareum

Sareum (AIM: SAR) is a 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, with a planned
initial focus on psoriasis.

Sareum is also developing SDC-1802, a TYK2/JAK1 inhibitor with a potential
application for cancer immunotherapy, and has recently initiated a preclinical
programme to develop TYK2/JAK1 inhibitors for neuroinflammatory diseases such
as multiple sclerosis and Parkinson's disease.

The Company is the license holder for SRA737, a clinical-stage Checkpoint
kinase 1 inhibitor that targets cancer cell replication and DNA damage repair
mechanisms.

Sareum Holdings plc is based in Cambridge, UK, and is quoted 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
(http://www.sareum.com)

 

 

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