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

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.”

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