Synairgen PLC (AIM:SNG, OTC:SYGGF) said it has been asked by the US National Institutes of Health (NIH) to “temporarily pause activities” as it prepares clinical supplies for ACTIV-2 phase III clinical trial of its lead asset SNG001.
It is doing this so it can modify the study design in "light of the emergence of the Omicron variant" and “until the timeline for the activation of this agent in the trial is clarified”.
In the same update, investors were told SNG001 has shown “potent antiviral activity” against Delta and Omicron virus variants in lab tests.
Synairgen also provided more detail on its SPRINTER phase III trial of SNG001. It said it is assessing the dataset from the study “in order to better understand all of the findings”.
It said the study pointed to an encouraging trend in the prevention of progression to severe disease and death (36% reduction in the pre-defined per-protocol population).
It added that the “company and its clinical advisors strongly believe merits further investigation in a platform trial which the company is actively investigating”.