Sareum Holdings PLC Dosing of first subjects in MAD Phase 1a trial (1921L)
04 Septiembre 2023 - 1:00AM
UK Regulatory
TIDMSAR
RNS Number : 1921L
Sareum Holdings PLC
04 September 2023
Sareum Holdings PLC
("Sareum" or the "Company")
Sareum starts dosing first subjects in the multiple ascending
dose part of Phase 1a clinical trial for SDC-1801
Cambridge, UK , 4(th) September 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 the
multiple ascending dose part of its Phase 1a clinical trial for
lead programme SDC-1801. Dosing has started at a specialist
clinical unit in Melbourne, Australia, and subjects will receive
SDC-1801 orally once daily for 10 days.
This follows approval by the safety review committee granted
upon review of preliminary data generated from the initial three
cohorts in the single ascending dose part of the study. The
committee deemed these data as satisfactory for the multiple
ascending dose part of the study to commence, as well as for
continued dose escalation in the single ascending dose part of the
study.
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 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.
Dr Tim Mitchell, CEO of Sareum, commented :
"We are delighted that the data generated to date supports the
safety review committee's approval to begin dosing the first
subjects in the multiple ascending dose part of our Phase 1a trial
of SDC-1801. Of particular importance are the pharmacokinetics
findings demonstrating that patients will be able to receive
SDC-1801 orally once daily. During this next phase of the study, we
expect valuable biomarker data to be generated, that will be
available upon completion of this part of the trial.
"As SDC-1801 continues to progress through the clinic on
schedule, we remain committed to bringing this innovative medicine
to patients with autoimmune disease. We look forward to the
completion of the Phase 1a study and to progression into Phase 1b,
subject to continuing positive safety results in the remainder of
the Phase 1a."
-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 www.sareum.com
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