Following the protracted stalemate with the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its clinical trial authorisation (CTA) for SDC-1801, Sareum has now announced the filing of an application to commence Phase I studies for SDC-1801 in Australia under the Clinical Trial Notification scheme. The company intends to initiate the first part of the Phase Ia/b clinical trial (safety and dose-finding study in healthy volunteers) following regulatory approval, expected in Q223. This will be followed by the Phase Ib study in psoriasis patients in 2024, provided safety is established. As a reminder, in November 2022, SDC-1801’s CTA was turned down by the MHRA and Sareum has been awaiting further clarity prior to data resubmission. We note that the net cash balance at end-June 2022 stood at £4.3m and based on historical burn rates of £0.5m per quarter, we estimate Sareum to be able to commence the Phase Ia trial but it will require additional funds to advance the studies.
