Rns5 May 2023 10:23
Sareum announces approval to initiate Phase 1 clinical trial of its lead product SDC-1801
Cambridge, UK, 5 May 2023 - Sareum Holdings plc (AIM: SAR), a biotechnology company developing next generation kinase inhibitors for autoimmune disease and cancer, is pleased to announce that its application to conduct Phase 1 clinical studies on SDC-1801 in Australia has been granted approval.
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. The Company's application under the Clinical Trial Notification (CTN) scheme has been approved by the Human Research Ethics Committee (HREC) and acknowledged by
Australia's medicines regulator, the Therapeutic Goods Administration (TGA), meaning the Phase 1 trial is now able to proceed.
With the approval, Sareum, working alongside specialist clinical units in
Melbourne, Australia, expects to initiate a Phase 1a trial as soon as possible to investigate the safety and pharmacokinetics of an oral formulation of
SDC-1801 in ascending doses administered to healthy subjects.
Provided satisfactory safety data are obtained from this initial study, a
Phase 1b clinical study is expected to commence in psoriasis patients in 2024.
Further details of the clinical trial are available on the Australian New
Zealand Clinical Trials Registry website at https://www.anzctr.org.au/TrialSearch.aspx#&&searchTxt=SDC-1801 (https://www.anzctr.org.au/TrialSearch.aspx#&&searchTxt=SDC-1801) .
TYK2/JAK1 inhibition has demonstrated benefits in maintaining a healthy immune system and has strong clinical validation in psoriasis and psoriatic arthritis. Psoriasis is an autoimmune dermatological condition affecting more than 60 million adults worldwide, with a market size for potential treatments estimated to be worth more than US$30 billion. Sareum believes that TYK2/JAK1 inhibition offers potential for increased efficacy in psoriasis, compared with existing approved therapies.
Dr Tim Mitchell, CEO of Sareum, commented: "The approval of this application is a very important step for Sareum and we are now ready to bring our lead asset into clinical development. We are very excited about the potential of SDC-1801, which we believe could offer superior efficacy compared to other currently-available small molecules for psoriasis and which has demonstrated a good safety profile in preclinical studies. We look forward to initiating our Phase 1 trial in the coming weeks." - Ends -
For further information, please contact:
Sareum Holdings plc
Tim Mitchell, CEO 01223 497700
Strand Hanson Limited (Nominated Adviser)
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