RE: Trading update 20211 Aug 2021 22:17
From 2020 trading update
Key Objectives
· Complete preclinical (IND-enabling) studies with at least one candidate by the end of 2020.
· Decide on the initial target indications during 2H 2020 as part of preparation for first-in-human studies.
· Build a robust preclinical data package to support ongoing partnering activities.
· Continue and advance initial discussions with potential partners to secure commercial licences for its assets when they reach late preclinical or early clinical stages.
SDC-1801 (autoimmune diseases)
SDC-1801 and related molecules have shown promising activity in autoimmune disease models, including psoriasis, rheumatoid arthritis, inflammatory bowel disease and systemic lupus erythematosus (SLE).
· SDC-1801 has demonstrated excellent tolerability in toxicology studies in rodents and work is continuing towards completing the dose-finding and longer-term toxicology studies ahead of human trials.
· A robust manufacturing route has been developed to produce active ingredient under GMP (Good Manufacturing Practice) conditions for both preclinical and clinical studies.
· A formulation that will successfully deliver a therapeutic dose level has been identified, however the Company is required to deliver very high doses to SDC-1801 in order to identify a toxic dose level (maximum tolerated dose), and formulation studies for this are still ongoing.
· Encouraging preclinical data reported with Sareum's TYK2/JAK1 inhibitors in SLE disease models. These studies were conducted by co-development partner SRI International (Menlo Park, CA, USA) under a US Department of Defense (DoD) grant and recently published on the website of the Defense Technical Information Center.
SDC-1802 (cancer immunotherapy)
SDC-1802 and related TYK2/JAK1 inhibitors have shown encouraging anti-tumour activity in multiple cancer disease models. Sareum retains global commercialisation rights for TYK2/JAK1 inhibitors with profiles optimised for oncology and immuno-oncology applications.