Sareum Holdings - SDC-1801 trial application refiled in Australia
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.Sareum Holdings is a holding company. Through its subsidiary, Co. is engaged as a specialist drug discovery and development company delivering targeted small molecule therapeutics, focusing on cancer and autoimmune disease, and licensing them to international pharmaceutical and biotechnology companies at the preclinical or early clinical trials stage. Co.'s drug development pipeline includes: Chk1 (SRA737), which targets genetically defined solid cancers; TYK2, which targets autoimmune diseases and cancer; and Aurora+FLT3, which targets Acute Myeloid Leukemia and other blood cancers.
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