Sareum Holdings PLC Approval to initiate Phase 1 clinical trial (5783Y)
05 May 2023 - 6:20PM
UK Regulatory
TIDMSAR
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
.
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
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