Synairgen announces inclusion of its inhaled interferon beta treatment in US NIH ACTIV-2 trial in COVID-19 outpatients

Synairgen announces inclusion of its inhaled interferon beta treatment in US NIH ACTIV-2 trial in COVID-19 outpatients

ACTIV partnership is funded by “Operation Warp Speed”, led by the US Government’s Department of Health and Human Services and designed to speed up the development of the most promising treatments and vaccine candidates for COVID-19

Southampton, UK – 25 January 2021: Synairgen plc (LSE: SNG), the respiratory drug discovery and development company, today announces a clinical trial agreement to include its inhaled interferon beta-1a treatment (SNG001) in the ACTIV-2/A5401 Phase II/III trial in patients with COVID-19 not yet requiring hospitalisation. The trial is sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH).

NIH’s Accelerating COVID-19 Therapeutic Inventions and Vaccines (ACTIV) (https://www.nih.gov/research-training/medical-research-initiatives/activ) 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 Phase II/III ACTIV-2 study, led by the NIAID-funded AIDS Clinical Trials Group (ACTG), is an adaptive, randomised, blinded, placebo-controlled trial. The Phase II evaluation of SNG001 will see the recruitment of up to a maximum of 220 participants across US sites, in a home-based setting, split between SNG001 and placebo, and a positive result enables progression into the Phase III part of the study.

NIAID is the regulatory sponsor and holder of the Investigational New Drug application to conduct the ACTIV-2 study, which is funded by 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.

Richard Marsden, CEO of Synairgen, said: “The inclusion of our inhaled interferon beta-1a treatment in the US Government-funded ACTIV-2 trial reflects the strong interest that our Phase II data has generated and the Company’s strong belief that this drug could play a vital role in the treatment of COVID-19. 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. We hope to gain valuable data from this trial, which will aid us in progressing approval of SNG001 as a treatment for COVID-19.”

In addition, Synairgen commenced dosing in an international 610 patient Phase III trial on 12 January 2021, assessing the efficacy of inhaled interferon beta in hospitalised patients with COVID-19.

Information within this announcement is deemed by the Company to constitute inside information under the Market Abuse Regulation (EU) No. 596/2014.

For further enquiries, please contact:

Synairgen plc

Richard Marsden, Chief Executive Officer

John Ward, Finance Director

Tel: + 44 (0) 23 8051 2800