REG - Sareum Holdings PLC - Initiation of food effects study for SDC-1801

Sareum HoldingsAnnouncement

09/11/2023 07:00

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RNS Number : 8566S  Sareum Holdings PLC  09 November 2023

 Sareum Holdings PLC

("Sareum" or the "Company")

Sareum initiates food effects study in Phase 1a trial for SDC-1801

Cambridge, UK, 9 November 2023 - Sareum Holdings plc (AIM: SAR), a
biotechnology company developing next generation kinase inhibitors for
autoimmune disease and cancer, today announces the dosing of the first
subjects in the food effects part of its Phase 1a clinical trial of lead
programme SDC-1801. Dosing has started at a specialist clinical unit in
Melbourne, Australia.

The food effects study is a key part of the Phase 1a trial, designed to
determine how the presence of food might affect the absorption and
pharmacokinetic profile of SDC-1801. This part of the study will inform
whether the drug should be taken with food or on an empty stomach, optimising
its potential benefits whilst potentially minimising any possible side
effects. This study runs in conjunction with the Single Ascending Dose (SAD)
and the Multiple Ascending Dose (MAD) parts of the trial, which are
concurrently dosing subjects as planned, ensuring a robust assessment of
SDC-1801's pharmacological profile.

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.

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: "The food effects study will
provide key information about the absorption of SDC-1801 in fed or fasted
healthy subjects, and forms an essential part of the safety data we are
compiling which will support the next stages of development. This is another
important milestone in our clinical development.

"We are pleased with the continued positive progress made in this trial and
look forward to obtaining full safety data in the first half of 2024."

-Ends-

For further information, please contact:

 Sareum Holdings plc

 Tim Mitchell, CEO                                   01223 497700

 Lauren Williams, Head of Investor Relations         ir@sareum.co.uk

 Strand Hanson Limited (Nominated Adviser)

 James Dance / James Bellman                         020 7409 3494

 Peel Hunt LLP (Joint Corporate Broker)

 James Steel / Patrick Birkholm                      020 7418 8900

 Hybridan LLP (Joint Corporate Broker)

 Claire Noyce                                        020 3764 2341

 Consilium Strategic Communications (Financial PR)

 Jessica Hodgson / Davide Salvi / Stella Lempidaki   020 3709 5700

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 https://sareum.com/
(https://sareum.com/)

About the Phase 1a trial of SDC-1801

 

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.

 

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