CTA application mid 20221 Apr 2022 09:42
RNS 21st Feb 22
The bit I like is:
The CTA is expected to be filed during mid-2022??
Are we entering mid 2022 all be it early when trials are said to start in H2 2022???? RNS for CTA could be soon?
SDC-1801 (autoimmune diseases and severe Covid-19)
• Progress made advancing SDC-1801 towards clinical development as a potential treatment for autoimmune diseases and the acute respiratory symptoms of Covid-19
• Final toxicology and safety studies required to file for an exploratory Clinical Trial Authorisation ("CTA") were successfully completed in Q4 2021, and the final report is expected in Q1 2022
• Preliminary findings from these studies continue to support Sareum's plans to enter SDC-1801 into a first-in-human (Phase 1a) clinical study in healthy volunteers, and allow selection of an initial dose range
• The CTA is expected to be filed during mid-2022
• The synthesis of SDC-1801 drug substance under GMP conditions for formulating as an oral capsule is nearing completion. Development of the capsule formulation, also under GMP, intended for use in the Phase 1 trial is progressing to plan
• Planning for first clinical study is underway and the trial is expected to begin in H2 2022, subject to CTA approval and drug product supply