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Dosing commences in Phase 1a trial of SDC-801
Dosing commences in Phase 1a trial of SDC-801.
About this update from Sareum Holdings Plc
[{"type":"text","content":"\n\n Sareum Holdings PLC\n(\"Sareum\" or the \"Company\")\nSareum announces dosing of first subjects in Phase 1a clinical trial for SDC-1801\nCambridge, UK, 6th June 2023 - Sareum Holdings plc (AIM: SAR), a clinical-stage biotechnology company developing next generation kinase inhibitors for autoimmune disease and cancer, today announces the successful dosing of the first subjects in a Phase 1a clinical trial for its lead programme SDC-1801. The dosing has started at a specialist clinical unit in Melbourne, Australia.\nSDC-1801 is a dual TYK2/JAK1 kinase 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.\nThe Phase 1a trial is designed to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of an oral formulation of SDC-1801 in healthy subjects (trial ID ACTRN12623000416695p). This will be a randomised, placebo-controlled trial with single and multiple ascending oral dose studies. \nFull safety data from this trial are expected to be available during the first half of 2024 and, provided satisfactory results are obtained, a Phase 1b clinical study is expected to commence as soon as possible thereafter in psoriasis patients.\nDr Tim Mitchell, CEO of Sareum, commented:\n\"We are delighted to begin dosing the first subjects in our Phase 1a trial of SDC-1801. Dual TYK2 and JAK1 inhibition offers significant potential benefits for immune health and we believe by targeting both these pathways, SDC-1801 could have the potential for superior efficacy in autoimmune disease compared to agents that block just one of the two kinases.\n\"Dosing of the first subjects in this trial is an important first step to establishing the safety and tolerability profile of SDC-1801 and we look forward to watching the trial progress.\"\nFurther Information on the Phase 1a Trial of SDC-1801\nThe phase 1a trial includes a single ascending dose study (Part 1), a multiple ascending dose study (Part 2) and a food effects study (Part 3). Part 1 will consist of at least 6 sequential, ascending dose cohorts of 8 subjects each (total of 48 subjects) randomised to receive SDC-1801 or matched placebo in a 3:1 ratio. Each subject will be in Part 1 for approximately 6 weeks (screening visit to follow-up visit).&...