Synairgen enters clinical trial deal with US government
Respiratory drug discovery and development company Synairgen announced a clinical trial agreement on Monday, to include its inhaled interferon beta-1a treatment ‘SNG001’ in the ACTIV-2/A5401 phase 2 and 3 trial in patients with Covid-19 not yet requiring hospitalisation.
The AIM-traded firm said the trial is sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH).
It said NIH's ‘Accelerating COVID-19 Therapeutic Inventions and Vaccines’ (ACTIV) programme is a public-private partnership to develop a coordinated research strategy to speed up the development of the most promising treatments and vaccine candidates for Covid-19.
ACTIV-2 is a master protocol designed for evaluating multiple investigational agents compared to placebo in adults with mild-to-moderate Covid-19, not requiring hospitalisation.
The company said the phase 2 and 3 ACTIV-2 study, led by the NIAID-funded AIDS Clinical Trials Group (ACTG), is an adaptive, randomised, blinded, placebo-controlled trial.
It said the phase 2 evaluation of SNG001 would see the recruitment of up to 220 participants across US sites, in a home-based setting, split between SNG001 and placebo, with a positive result set to enable progression into the phase 3 part of the study.
NIAID is the regulatory sponsor and holder of the investigational new drug application to conduct the ACTIV-2 study, which was being funded under ‘Operation Warp Speed’ - a partnership led by the US Department of Health and Human Services through NIAID to investigate and coordinate the development, manufacturing, and distribution of Covid-19 diagnostics, therapeutics and vaccines.
“The inclusion of our inhaled interferon beta-1a treatment in the US Government-funded ACTIV-2 trial reflects the strong interest that our phase 2 data has generated and the company's strong belief that this drug could play a vital role in the treatment of Covid-19,” said chief executive officer Richard Marsden.
“As an inhaled treatment, SNG001 offers ease of use that makes it possible for patients to administer it conveniently at home, reducing the risk of virus transmission during hospital visits and relieving the major logistical strain on healthcare systems.
“At-home treatments also have the potential to be taken much earlier in the course of the illness, preventing the progression of the virus in the lower respiratory tract and, in the scenario where hospitals are at capacity, treating patients in the home setting could be the only option.”
Synairgen said that in addition, it had started dosing in an international 610 patient phase 3 trial on 12 January, assessing the efficacy of inhaled interferon beta in hospitalised patients with Covid-19.
At 1138 GMT, shares in Synairgen were up 12.94% at 192p.