Sareum Holdings plc
("Sareum" or the "Company")
Positive
Data from SDC-1801 Phase 1 Clinical Trial
Cambridge, UK, 1 July 2024 -
Sareum Holdings plc (AIM: SAR), a clinical-stage biotechnology
company developing next-generation kinase inhibitors for autoimmune
disease and cancer, is pleased to announce positive topline data
from its Phase 1a clinical trial of SDC-1801, a dual TYK2/JAK1
kinase inhibitor being developed as a
potential new therapeutic for a range of autoimmune
diseases.
Following the dosing of the final
cohort in the Multiple Ascending Dose stage of the trial, and
review of the initial data by the Safety Review Committee, the
Company reports that:
·
Blood plasma levels of SDC-1801 significantly in excess of
the predicted therapeutic exposure were achieved, with a half-life
of between 17 and 20 hours observed, which suggests that once-daily
dosing will be possible*
· No
deaths or serious adverse events due to SDC-1801 were
reported
·
Although data remains blinded, there appear to be no
significant changes in blood cell counts or increases in serum
creatinine levels, which may be dose limiting side-effects of
brepocitinib, currently the most advanced TYK2/JAK1 dual
inhibitor
*Half-life is an estimation of the
time it takes for an initial concentration of SDC-1801 to be
reduced by half in the body.
The Company expects that further
data, unblinded from drug/placebo recipients, including details of
any mild or moderate adverse events and biomarkers of TYK2 and/or
JAK1 inhibition, will be available in Q3 2024.
Dr
Tim Mitchell, Chief Executive Officer of Sareum,
commented: "We are delighted that the
dosing of subjects in the SDC-1801 clinical trial has been
completed successfully and without any serious adverse events. We
look forward to building a strong data package to advance SDC-1801
to the next stage of its development."
Dr
John Reader, Chief Scientific Officer of Sareum,
added: "The success of this stage
of the clinical trial demonstrates that high blood levels of a dual
TYK2/JAK1 kinase inhibitor can be achieved without serious side
effects. Together with the long half-life observed, we believe this
potentially gives SDC-1801 significant advantages over its
competitors. We're grateful to the volunteers who participated in
this trial, and to the clinical staff who enabled its timely
completion."
- END -
For Further
Information:
|
Sareum
Holdings plc
Tim Mitchell,
CEO
|
01223 497700
ir@sareum.co.uk
|
|
Strand Hanson
Limited (Nominated Adviser)
James Dance / James Bellman
|
020 7409 3494
|
|
Hybridan LLP
(Corporate Broker)
Claire Noyce
|
020 3764 2341
|
|
ICR Consilium
(Financial PR)
Jessica Hodgson / Davide Salvi / Kumail Waljee
|
0203 709 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.
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 is
currently completing Phase 1 clinical development.
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.