REG - Sareum Holdings PLC - SDC-1801: Preclinical Toxicology Report Received

Sareum HoldingsAnnouncement

16/03/2022 07:00

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RNS Number : 8792E  Sareum Holdings PLC  16 March 2022

Sareum Holdings plc

("Sareum" or the "Company")

SDC-1801 on Track to Enter Clinical Development in H2 2022 following Positive
Preclinical Data Analysis and Toxicology Report

Cambridge, UK, 16 March 2022 - Sareum Holdings plc (AIM: SAR), the specialist
drug development company, is pleased to provide an update on the development
of its proprietary TYK2/JAK1 inhibitor SDC-1801 towards first-in-human trials.
As disclosed in the Company's half-year results on 21 February 2022, the data
analysis from the preclinical toxicology and safety studies required to file
for an exploratory Clinical Trial Authorisation ("CTA") is complete. The
Company has now received the final signed report from the Contract Research
Organisation that conducted these studies and, as previously reported, these
data fully support the Company's plan to submit a CTA application in mid-2022
and to commence a Phase 1a clinical trial with SDC-1801 in H2 2022.

SDC-1801 is being developed as a potential new treatment for a range of
autoimmune diseases and for the acute respiratory symptoms of Covid-19.

The report confirms that the studies met their objectives of identifying any
organs or tissues that might be susceptible to high-dose toxicity and
determining an appropriate dose range to test in first-in-human studies.

Sareum is working with specialist clinical trial consultants to design the
first clinical trial with SDC-1801. This Phase 1a trial will investigate the
safety of ascending doses of SDC-1801 in healthy subjects prior to the
selection of an initial indication for further clinical study in patients in
any subsequent trials. The Phase 1a trial will also investigate the effect of
SDC-1801 on certain biomarkers of autoimmune disease that could be predictive
of efficacy when tested in patients.

In addition, the manufacture of SDC-1801 drug substance and oral capsule
formulation under Good Manufacturing Practice ("GMP") conditions is on track
to enable the Phase 1a trial to commence in H2 2022, pending their successful
completion and the requisite CTA approval.

Dr John Reader, Chief Scientific Officer of Sareum, commented: "We are pleased
to have successfully completed the preclinical toxicology studies and have now
received the final report, which will form a key part of the planned CTA
application for SDC-1801. We are particularly encouraged that the promising
data and progress with the manufacture of SDC-1801 in capsule form continue to
support our intention to file the CTA application in mid-year and our plan to
begin the first clinical trial with SDC-1801 during H2 2022."

For further information, please contact:

 Sareum Holdings plc

 Tim Mitchell, CEO                                    01223 497700

 Strand Hanson Limited (Nominated Adviser)

 James Dance / James Bellman                          020 7409 3494

 Peel Hunt LLP (Joint Corporate Broker)

 James Steel                                          020 7418 8900

 Hybridan LLP (Joint Corporate Broker)

 Claire Noyce                                         020 3764 2341

 MEDiSTRAVA Consulting (Financial PR)

 Mark Swallow / George Underwood / Evelyn McCormack   020 3928 6900

 

About Sareum

Sareum is a specialist drug development company delivering targeted small
molecule therapeutics to improve the treatment of cancer and autoimmune
diseases. The Company aims to generate value through licensing its candidates
to international pharmaceutical and biotechnology companies at the preclinical
or early clinical trials stage.

Sareum is advancing internal programmes focused on distinct dual tyrosine
kinase 2 (TYK2) / Janus kinase 1 (JAK1) inhibitors through preclinical
development as therapies for autoimmune diseases, including the 'cytokine
storm' immune system overreaction to Covid-19 and other viral infections,
(SDC-1801) and cancer immunotherapy (SDC-1802).

Sareum also has an economic interest in SRA737, a clinical-stage oral,
selective Checkpoint kinase 1 (Chk1) inhibitor that targets cancer cell
replication and DNA damage repair mechanisms. Preliminary Phase 2 and
comprehensive preclinical data suggest SRA737 may have broad application in
combination with other oncology and immune-oncology drugs in genetically
defined patients.

SRA737 was discovered and initially developed by scientists at The Institute
of Cancer Research in collaboration with Sareum, and with funding from Sareum
and Cancer Research UK. SRA737 was licensed by CRT Pioneer Fund (CPF) to
Sierra Oncology Inc. Sierra continues to explore options that would enable the
development of SRA737 to advance.

Sareum Holdings plc 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 (http://www.sareum.com)

- Ends -

 

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