Synairgen has temporarily halted the ACTIV-2 Phase III clinical trial of its therapy SNG001 for Covid-19.
The latest move comes after the requirement to modify the trial design due to the emergence of the SARS-CoV-2 virus’ Omicron variant.
Furthermore, the team of the US National Institutes of Health (NIH) ACTIV-2 trial asked the company to provisionally halt activities to ready clinical supplies for ACTIV-2 Phase III until the timeline for the activation of SNG001 in the study is clarified.
Synairgen is awaiting results from the Phase II part of the US NIH ACTIV-2 trial conducted on Covid-19 patients in the at-home setting. The data is anticipated in the middle of this year.
An inhaled formulation, SNG001 contains the broad-spectrum antiviral protein interferon beta.
According to data from in vitro studies carried out at Viroclinics-DDL in the Netherlands, SNG001 demonstrated to possess potent antiviral activity against Delta and Omicron viral variants at doses that are easily achievable after inhaled administration of interferon-beta.
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As reported in February this year, the company is assessing the top-line as well full dataset from the Phase III SPRINTER clinical trial to attain a better understanding of the results.
Synairgen will report the findings of this assessment soon in compliance with regulatory requirements.
The SPRINTER trial showed a favourable trend in preventing progression to severe disease and morality with a 36% decline in the pre-defined per-protocol population.
Synairgen and its clinical advisors believe that the data warrants additional analysis in a platform trial, which the company is currently studying.
Synairgen reported in February this year that the international Phase III trial of SNG001 in Covid-19 patients admitted to the hospital failed to meet the primary or secondary efficacy endpoints.