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Sareum is a UK-based drug development company, specialising in small molecule kinase inhibitors. Its flagship programmes are its pre-clinical TYK2/JAK1 inhibitors, SDC-1801 for autoimmune diseases and SDC-1802 for cancer. SDC-1801 is undergoing advanced dose finding and toxicology studies with a target to file a CTA in mid-2021. Other programmes include the CHK1 inhibitor SRA737 (Sareum holds a 27.5% economic interest), previously out licensed to Sierra Oncology and the de-prioritised FLT3+Aurora kinase.
Sareum has announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has turned down the clinical trial authorisation (CTA) for SDC-1801 based on the submitted data package. While Sareum awaits the formal letter of non-acceptance, initial insights suggest that the MHRA will seek a review by the UK Good Laboratory Practice Monitoring Authority or request additional information to support the submitted non-clinical data. As a reminder, Sareum filed the CTA for SDC-1801 in July 2022 with the intention of commencing the Phase Ia trial in Q4 CY22. While the company is seeking further clarification from the MHRA on the requirements for resubmission, we now anticipate a delay in launching clinical activity.