In an encouraging development, Sareum announced that its clinical trial application to commence Phase I studies for its lead asset, SDC-1801 (a TYK2/JAK1 inhibitor), has been approved by Australian authorities. Sareum had filed its application in March 2023 under the Clinical Trial Notification Scheme (CTN) after stalled discussions with the UK Medicines and Healthcare products Regulatory Agency (MHRA) for SDC-1801’s clinical trial authorisation (CTA) application based on the submitted data package. Following the Australian approval, Sareum intends to initiate the Phase Ia clinical trial (safety and dose-finding study in healthy volunteers) in Q223, which if successful will be followed by a Phase Ib study in 2024 in patients with plaque psoriasis. With burn rates likely to rise with trial commencement (c £0.5m/quarter currently), we expect Sareum will need to raise additional funds before end-CY23 (H123 cash balance of £2.9m).
