By Josh White
Date: Thursday 17 Mar 2022
LONDON (ShareCast) - (Sharecast News) - Inhaled antiviral treatment developer Synairgen said on Thursday that the US National Institute of Allergy and Infectious Diseases (NIAID) has halted all patient recruitment in its phase 2 and 3 Covid-19 trial, which included the assessment of its 'SNG001' treatment.
The AIM-traded firm said the halt was due to the "significant shift" in the nature of the pandemic, which would necessitate a "substantial modification" of the study design.
Such a modification was not feasible in the multiple treatment arm platform trial.
Synairgen said due to the changes in the pandemic, a new clinical trial design would be needed to evaluate the efficacy of SNG001 against Covid-19.
As a result, lead investigators from the ACTIV-2 trial team and Synairgen were in ongoing discussions, to try to identify an appropriate clinical trial to continue the evaluation of SNG001.
The company said the National Institutes of Health (NIH)-led ACTIV-2 trial was designed to investigate potential therapies in non-hospitalised adults experiencing mild-to-moderate Covid-19.
SNG001 was included in the study in February 2021, with the independent data safety monitoring board recommending it advance from phase 2 to phase 3 in October.
"Conducting clinical trials in the time of Covid-19 is challenging but as important now as at the start of the pandemic," said chief executive officer Richard Marsden.
"Even with an improved standard of care, there remains a critical need to prevent progression to severe disease and death.
"As such, we are actively seeking inclusion in platform trials for hospitalised patients and are working closely with the NIH to also find a suitable trial for SNG001 in home-based patients."
At 1216 GMT, shares in Synairgen were down 18.23% at 21.26p.