Last checked at 8 Nov 2022 17:23
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."
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For further information, please contact:
Sareum Holdings plc Tim Mitchell, CEO
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01223 497700 |
Strand Hanson Limited (Nominated Adviser) James Dance / James Bellman
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020 7409 3494 |
Peel Hunt LLP (Joint Corporate Broker) James Steel / Oliver Duckworth
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020 7418 8900 |
Hybridan LLP (Joint Corporate Broker) Claire Noyce
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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