REG - Sareum Holdings PLC - Approval to initiate Phase 1 clinical trial

Sareum HoldingsAnnouncement

05/05/2023 09:30

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RNS Number : 5783Y  Sareum Holdings PLC  05 May 2023

Sareum Holdings PLC

("Sareum" or the "Company")

Sareum announces approval to initiate Phase 1 clinical trial of its lead
product SDC-1801

Cambridge, UK, 5 May 2023 - Sareum Holdings plc (AIM: SAR), a biotechnology
company developing next generation kinase inhibitors for autoimmune disease
and cancer, is pleased to announce that its application to conduct Phase 1
clinical studies on SDC-1801 in Australia has been granted approval.

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. The Company's
application under the Clinical Trial Notification (CTN) scheme has been
approved by the Human Research Ethics Committee (HREC) and acknowledged by
Australia's medicines regulator, the Therapeutic Goods Administration (TGA),
meaning the Phase 1 trial is now able to proceed.

With the approval, Sareum, working alongside specialist clinical units in
Melbourne, Australia, expects to initiate a Phase 1a trial as soon as possible
to investigate the safety and pharmacokinetics of an oral formulation of
SDC-1801 in ascending doses administered to healthy subjects.

Provided satisfactory safety data are obtained from this initial study, a
Phase 1b clinical study is expected to commence in psoriasis patients in 2024.

Further details of the clinical trial are available on the Australian New
Zealand Clinical Trials Registry website at
https://www.anzctr.org.au/TrialSearch.aspx#&&searchTxt=SDC-1801
(https://www.anzctr.org.au/TrialSearch.aspx#&&searchTxt=SDC-1801) .

TYK2/JAK1 inhibition has demonstrated benefits in maintaining a healthy immune
system and has strong clinical validation in psoriasis and psoriatic
arthritis. Psoriasis is an autoimmune dermatological condition affecting more
than 60 million adults worldwide, with a market size for potential treatments
estimated to be worth more than US$30 billion. Sareum believes that TYK2/JAK1
inhibition offers potential for increased efficacy in psoriasis, compared with
existing approved therapies.

Dr Tim Mitchell, CEO of Sareum, commented:

"The approval of this application is a very important step for Sareum and we
are now ready to bring our lead asset into clinical development.  We are very
excited about the potential of SDC-1801, which we believe could offer superior
efficacy compared to other currently-available small molecules for psoriasis
and which has demonstrated a good safety profile in preclinical studies. We
look forward to initiating our Phase 1 trial in the coming weeks."

- Ends -

 

For further information, please contact:

 Sareum Holdings plc

 Tim Mitchell, CEO                                   01223 497700

 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   0203 709 5700

 

The information contained within this announcement is deemed to constitute
inside information as stipulated under the Market Abuse Regulations (EU) No.
596/2014, which is part of UK law by virtue of the European Union (Withdrawal)
Act 2018.

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
(about:blank)

 

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