Last checked at 16 Mar 2022 07:00
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
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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
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020 7418 8900 |
Hybridan LLP (Joint Corporate Broker) Claire Noyce
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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
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