Sareum Holdings PLC - Cambridge-based biotechnology company developing kinase inhibitors for autoimmune disease and cancer - On Wednesday, says it has begun an application to perform phase one clinical studies on SDC-1801 in Australia under the clinical trial notification scheme.
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.
Documents required to initiate the trial under the CTN scheme have been submitted to a Human Research Ethics Committee in Australia. A decision on approval by the HREC and acceptance of the CTN by Australia's medicines regulator, the Therapeutic Goods Administration, is expected in the second quarter of 2023.
Company adds that further clarity requested by Sareum from the UK Medicines & Healthcare Products Regulatory Authority regarding its original clinical trial authorisation application has not been received. Consequently, company decides to transfer the clinical trial to Australia to progress the development of SDC-1801.
Preclinical development activities required for the application have been successfully concluded. Synthesis of SDC-1801 drug substance under Good Manufacturing Practice conditions has also been completed successfully. GMP-compliant manufacture of capsules of SDC-1801, for use in the phase one trial, is also complete.
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By Heather Rydings, Alliance News senior economics reporter
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