Sareum Holdings PLC Dosing commences in Phase 1a trial of SDC-801 (7814B)
06 Junio 2023 - 1:00AM
UK Regulatory
TIDMSAR
RNS Number : 7814B
Sareum Holdings PLC
06 June 2023
Sareum Holdings PLC
("Sareum" or the "Company")
Sareum announces dosing of first subjects in Phase 1a clinical
trial for SDC-1801
Cambridge, UK , 6(th) June 2023 - Sareum Holdings plc (AIM:
SAR), a clinical-stage biotechnology company developing next
generation kinase inhibitors for autoimmune disease and cancer,
today announces the successful dosing of the first subjects in a
Phase 1a clinical trial for its lead programme SDC-1801. The dosing
has started at a specialist clinical unit in Melbourne,
Australia.
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.
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 will be a randomised,
placebo-controlled trial with single and multiple ascending oral
dose studies.
Full safety data from this 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 :
"We are delighted to begin dosing the first subjects in our
Phase 1a trial of SDC-1801. Dual TYK2 and JAK1 inhibition offers
significant potential benefits for immune health and we believe by
targeting both these pathways, SDC-1801 could have the potential
for superior efficacy in autoimmune disease compared to agents that
block just one of the two kinases.
"Dosing of the first subjects in this trial is an important
first step to establishing the safety and tolerability profile of
SDC-1801 and we look forward to watching the trial progress."
Further Information on the Phase 1a Trial of SDC-1801
The phase 1a trial includes a single ascending dose study (Part
1), a multiple ascending dose study (Part 2) and a food effects
study (Part 3). Part 1 will consist of at least 6 sequential,
ascending dose cohorts of 8 subjects each (total of 48 subjects)
randomised to receive SDC-1801 or matched placebo in a 3:1 ratio.
Each subject will be in Part 1 for approximately 6 weeks (screening
visit to follow-up visit). Part 2 (multiple ascending dose) is
planned to commence after the Safety Review Committee (SRC) has
evaluated the available data from at least Cohorts A, B, and C in
Part 1.
The multiple ascending dose part of the trial will consist of at
least 4 sequential, ascending doses of SDC-1801 or matched placebo
cohorts (cohorts A to D). Each cohort in Part 2 will consist of 8
subjects (a total of 32 subjects). Each subject will be in the
study for approximately 8 weeks. Part 3 of the study is expected to
run in parallel with Part 2, and will examine how food affects the
absorption of SDC-1801.
The Company expects to provide a further update on the trial
once initial safety and pharmacokinetic data observed in the single
ascending dose study provide sufficient support for progression to
Part 2 of the study, expected in H2 2023.
-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 / 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 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 www.sareum.com
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