Sareum Holdings PLC Initiation of food effects study for SDC-1801 (8566S)
09 Noviembre 2023 - 1:00AM
UK Regulatory
TIDMSAR
RNS Number : 8566S
Sareum Holdings PLC
09 November 2023
Sareum Holdings PLC
("Sareum" or the "Company")
Sareum initiates food effects study in Phase 1a trial for
SDC-1801
Cambridge, UK , 9 November 2023 - Sareum Holdings plc (AIM:
SAR), a biotechnology company developing next generation kinase
inhibitors for autoimmune disease and cancer, today announces the
dosing of the first subjects in the food effects part of its Phase
1a clinical trial of lead programme SDC-1801. Dosing has started at
a specialist clinical unit in Melbourne, Australia.
The food effects study is a key part of the Phase 1a trial,
designed to determine how the presence of food might affect the
absorption and pharmacokinetic profile of SDC-1801. This part of
the study will inform whether the drug should be taken with food or
on an empty stomach, optimising its potential benefits whilst
potentially minimising any possible side effects. This study runs
in conjunction with the Single Ascending Dose (SAD) and the
Multiple Ascending Dose (MAD) parts of the trial, which are
concurrently dosing subjects as planned, ensuring a robust
assessment of SDC-1801's pharmacological profile.
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.
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 : "The food effects
study will provide key information about the absorption of SDC-1801
in fed or fasted healthy subjects, and forms an essential part of
the safety data we are compiling which will support the next stages
of development. This is another important milestone in our clinical
development.
"We are pleased with the continued positive progress made in
this trial and look forward to obtaining full safety data in the
first half of 2024 ."
-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 https://sareum.com/
About the Phase 1a trial of SDC-1801
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.
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