Sareum Holdings PLC
("Sareum"
or the "Company")
Update on SDC-1801 Clinical Trial
Progress
-
Sareum completes dosing in
the single ascending dose (SAD) part and the food effect study of
Phase 1a clinical trial for
SDC-1801
-
Preliminary results
indicate the potential of SDC-1801 to achieve therapeutically
effective dose levels with no serious adverse
events
Cambridge,
UK, 15
February 2024 - Sareum
Holdings plc (AIM: SAR), a clinical-stage biotechnology company
developing next generation kinase inhibitors for autoimmune disease
and cancer, today announces the completion of the single ascending
dose (SAD) part and the food effect study of its Phase 1a clinical
trial for the lead programme SDC-1801.
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).
Dosing of the final subjects
in the SAD part of the trial has now concluded and the safety
review committee for the trial has reviewed available data.
The SAD study randomised participants in a 3:1 ratio to a
single dose of SDC-1801 or placebo in six dose
cohorts. Preliminary blinded safety,
tolerability and pharmacokinetics data from the trial indicate a
favourable profile and support oral dosing of patients once daily.
These preliminary results indicate that SDC-1801 has the potential
to achieve therapeutically effective dose levels with no serious
adverse events.
The food effect study part of the
trial has also been completed. The results of this study
demonstrated no significant food effect on SDC-1801 blood levels,
which will allow full flexibility in dose timing in future clinical
studies.
The multiple ascending dose study is ongoing
and full safety data from the Phase 1a clinical trial are expected
to be available during the first half of 2024. If the results are
satisfactory and subject to financing, regulatory requirements, and
recruitment preparations, the Company plans to initiate a Phase 1b
clinical study. The goal is to recruit up to 24 psoriasis patients,
with the study expected to be completed by the end of
2024.
Dr
Tim Mitchell, CEO of Sareum, commented: "We're pleased to announce that
Sareum has cleared an important milestone in this trial. We are
encouraged by the preliminary data from the SAD and food effect
parts of the Phase 1a trial for SDC-1801, which support our
confidence in the trial and the broader clinical
strategy.
"These are
preliminary results but if we continue to see the positive safety
profile and pharmacokinetic data we have seen so far, this will
underpin our planning for the Phase 1b part of the study and
beyond. We look forward to the data from the multiple ascending
dose part of this trial, which will help us advance towards this
critical next point in the study."
-Ends-
For further
information, please contact:
Sareum Holdings plc
Tim Mitchell, CEO
Lauren Williams, Head of Investor
Relations
|
01223 497700
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
|
ICR Consilium (Financial
PR)
Jessica Hodgson / Davide Salvi /
Kumail Waljee
|
020 3709 5700
|
The
information contained within this announcement is deemed by the
Company to constitute inside information as stipulated under the
Market Abuse Regulation (EU) No. 596/2014 as it forms part of
United Kingdom domestic law by virtue of the European Union
(Withdrawal) Act 2018, as amended by virtue of the Market Abuse
(Amendment) (EU Exit) Regulations 2019 ("UK
MAR").
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 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