Rns4 Sep 2023 07:03
REG – Sareum Holdings PLC – Dosing of first subjects in MAD Phase 1a trial
04 Sep 2023 07:00
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RNS Number : 1921L Sareum Holdings PLC 04 September 2023 Sareum Holdings PLC ("Sareum" or the "Company")
Sareum starts dosing first subjects in the multiple ascending dose part of
Phase 1a clinical trial for SDC-1801
Cambridge, UK, 4(th) September 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 the multiple ascending dose part of its Phase 1a clinical trial for lead programme SDC-1801. Dosing has started at a specialist clinical unit in Melbourne, Australia, and subjects will receive
SDC-1801 orally once daily for 10 days.
This follows approval by the safety review committee granted upon review of preliminary data generated from the initial three cohorts in the single ascending dose part of the study. The committee deemed these data as satisfactory for the multiple ascending dose part of the study to commence, as well as for continued dose escalation in the single ascending dose part of the study.
SDC-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.
The 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 is a randomised, placebo-controlled trial with single and multiple ascending oral dose studies.
This trial includes a single ascending dose study (Part 1), a multiple ascending dose study (Part 2) and a food effects study (Part 3).
The safety and pharmacokinetics data from the initial cohorts in Part 1 of the trial indicate a favourable profile and fully support oral dosing of patients once daily. Full safety data from the Phase 1a 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.
Dr Tim Mitchell, CEO of Sareum, commented: "We are delighted that the data generated to date supports the safety review committee's approval to begin dosing the first subjects in the multiple ascending dose part of our Phase 1a trial of SDC-1801. Of particular importance are the pharmacokinetics findings demonstrating that patients will be able to receive SDC-1801 orally once daily. During this next phase of the study, we expect valuable biomarker data to be generated, that will be available upon completion of this part of the
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