Business
Update on SDC-1801
Update on SDC-1801.
About this update from Sareum Holdings Plc
[{"type":"text","content":"\n \n \n Sareum Holdings PLC\n \n \n (\"Sareum\" or the \"Company\")\n \n \n \n Application in Australia for the Clinical Development of\nTYK2/JAK1 Inhibitor SDC-1801\n \n \n \n \n Cambridge, UK\n \n , 15 March\n \n 2023\n \n - Sareum Holdings plc (AIM: SAR), a biotechnology company developing next generation kinase inhibitors for autoimmune disease and cancer, announces today that it has initiated an application\n to perform Phase 1 clinical studies on SDC-1801 in Australia under the Clinical Trial Notification (CTN) scheme.\n \n \n SDC-1801 is a TYK2/JAK1 inhibitor being developed as a potential new therapeutic for a range of autoimmune diseases with an initial focus on psoriasis, an autoimmune condition affecting the skin.\n Documents required to initiate the trial under the CTN scheme have been submitted to a Human Research Ethics Committee (HREC) in Australia. A decision on approval by the HREC and acceptance of the CTN by Australia's medicines regulator, the Therapeutic Goods Administration (TGA), is expected in Q2 2023.\n \n \n Sareum, working alongside specialist consultants, contract research organisations (CROs), and clinical units, has designed a Phase 1a/b clinical trial with SDC-1801 in healthy subjects and psoriasis patients. Subject to regulatory approval being granted, Sareum plans to commence a Phase 1a trial as soon as possible to investigate the safety and tolerability of an oral formulation of SDC-1801 in ascending doses administered to healthy subjects. If the safety data proves satisfactory, the Company intends to commence a Phase 1b clinical study in psoriasis patients in 2024.\n \n \n Australia offers state-of-the-art research facilities and an efficient approval process, making it an attractive location for research and development. Moreover, the country provides significant tax incentives for companies that conduct their research in Australia, allowing them to claim up to 43.5% of their eligible R&D expenditure as a cash payment. As such, Sareum has established the required local presence by setting up a legal entity in Australia. \n \n \n Further clarity requested by Sareum from the UK Medicines and Healthcare Products Regulatory Authority (MHRA) regarding its original clinical trial authorisation application has not been received. In parallel, the Company has evaluated alternative opti...