SNG001 was investigated independently as part of the US National Institute of Health’s ACTIV programme to accelerate the development of the most promising COVID-19 treatments. The ACTIV-2 study (ClinicalTrials.gov Identifier: NCT04518410), was sponsored by the National Institute of Allergy and Infectious Diseases (NIAID).
Based on the study results, the Independent Data Safety Monitoring Board for ACTIV-2 recommended in October 2021 that SNG001 advance from Phase 2 into Phase 3 in the ACTIV-2 trial. However, in March 2022 as the Company and the ACTIV-2 team were preparing to initiate recruitment for Phase 3, the NIAID halted all patient recruitment in ACTIV-2 and discontinued all arms of the trial, including the one to evaluate SNG001, due to the
significant shift in the nature of the pandemic which would necessitate a substantial modification of the study design which was not feasible in a multiple treatment-arm platform trial of this size.
Full results from the Phase 2 part of the study, including other key endpoints, will be presented and/or published by the NIH in due course.