REG - Sareum Holdings PLC - Update on SDC-1801 CTA Application

Sareum HoldingsAnnouncement

08/11/2022 17:30

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RNS Number : 7388F  Sareum Holdings PLC  08 November 2022

Sareum Holdings PLC

("Sareum" or the "Company")

Update on SDC-1801 CTA Application

 

Cambridge, UK, 8 November 2022 - Sareum Holdings plc (AIM: SAR), a
biotechnology company developing next generation kinase inhibitors for
autoimmune disease and cancer, announces that the UK Medicines and Healthcare
Products Regulatory Agency ("MHRA") has today given notice to the Company that
it has not been able to approve the Clinical Trial Authorisation ("CTA") to
evaluate the safety and tolerability of its lead programme SDC-1801.

Whilst the Company has yet to receive a formal letter of non-acceptance, the
MHRA has indicated that it seeks a review by the UK Good Laboratory Practice
(GLP) Monitoring Authority, or further support, of the non-clinical data
submitted as part of the application to approve the clinical study. Sareum and
its advisors are seeking additional clarification from the MHRA and will
provide an update on next steps for resubmission as soon as possible.

Due to uncertainties around the timeline for resubmission, we therefore no
longer expect the trial to commence before the end of 2022.

Dr Tim Mitchell, Chief Executive Officer of Sareum, commented: "We are
surprised and disappointed by this response. We believe Sareum made a
compelling case to the regulatory authority with a robust non-clinical data
package, generated in collaboration with world-leading, internationally
recognised CROs, to support our application. We are committed to getting
clarification on next steps."

- Ends -

 

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 / Oliver Duckworth                      020 7418 8900

 Hybridan LLP (Joint Corporate Broker)

 Claire Noyce                                        020 3764 2341

 Consilium Strategic Communications (Financial PR)

 Jessica Hodgson / Davide Salvi / Stella Lempidaki   0203 709 5700

 

The information contained within this announcement is deemed to constitute
inside information as stipulated under the Market Abuse Regulations (EU) No.
596/2014, which is part of UK law by virtue of the European Union (Withdrawal)
Act 2018.

About Sareum

Sareum Holdings (AIM:SAR) is a  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 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 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)

 

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