REG - Sareum Holdings PLC - Update on SDC-1801

Sareum HoldingsAnnouncement

15/03/2023 07:15

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RNS Number : 9767S  Sareum Holdings PLC  15 March 2023

 Sareum Holdings PLC

("Sareum" or the "Company")

Application in Australia for the Clinical Development of

TYK2/JAK1 Inhibitor SDC-1801

Cambridge, UK, 15 March 2023 - Sareum Holdings plc (AIM: SAR), a biotechnology
company developing next generation kinase inhibitors for autoimmune disease
and cancer, announces today that it has initiated an application to perform
Phase 1 clinical studies on SDC-1801 in Australia under the Clinical Trial
Notification (CTN) scheme.

SDC-1801 is a TYK2/JAK1 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. Documents required to
initiate the trial under the CTN scheme have been submitted to a Human
Research Ethics Committee (HREC) in Australia. A decision on approval by the
HREC and acceptance of the CTN by Australia's medicines regulator, the
Therapeutic Goods Administration (TGA), is expected in Q2 2023.

Sareum, working alongside specialist consultants, contract research
organisations (CROs), and clinical units, has designed a Phase 1a/b clinical
trial with SDC-1801 in healthy subjects and psoriasis patients. Subject to
regulatory approval being granted, Sareum plans to commence a Phase 1a trial
as soon as possible to investigate the safety and tolerability of an oral
formulation of SDC-1801 in ascending doses administered to healthy subjects.
If the safety data proves satisfactory, the Company intends to commence a
Phase 1b clinical study in psoriasis patients in 2024.

Australia offers state-of-the-art research facilities and an efficient
approval process, making it an attractive location for research and
development. Moreover, the country provides significant tax incentives for
companies that conduct their research in Australia, allowing them to claim up
to 43.5% of their eligible R&D expenditure as a cash payment. As such,
Sareum has established the required local presence by setting up a legal
entity in Australia.

Further clarity requested by Sareum from the UK Medicines and Healthcare
Products Regulatory Authority (MHRA) regarding its original clinical trial
authorisation application has not been received. In parallel, the Company has
evaluated alternative options and has decided to transfer the clinical trial
to Australia to progress the development of SDC-1801.

Preclinical development activities required for the application have been
successfully concluded. Synthesis of SDC-1801 drug substance under Good
Manufacturing Practice (GMP) conditions has also been completed successfully,
with a surplus of material for the planned Phase 1 clinical trials.
GMP-compliant manufacture of capsules of SDC-1801, for use in the Phase 1
trial, is also complete.

Dr Tim Mitchell, CEO of Sareum, commented: "This application is an important
step for Sareum in advancing SDC-1801, our lead TYK2/JAK1 inhibitor, into
clinical development. Australia is an ideal location for these studies and we
look forward to reporting further progress in due course."

For further information, please contact:

 Sareum Holdings plc

 Tim Mitchell, CEO                                   01223 497700

 Alex Harrison, Investor Relations                   ir@sareum.co.uk (mailto:ir@sareum.co.uk)

 Strand Hanson Limited (Nominated Adviser)

 James Dance / James Bellman                         020 7409 3494

 Peel Hunt LLP (Joint Corporate Broker)

 James Steel / Oliver Duckworth                      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 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, which, is planned
to enter 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
(http://www.sareum.com/)

 

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