Synairgen announces that dosing has commenced with its inhaled interferon beta product in US Government-funded NIH ACTIV-2 trial in COVID-19 outpatients

Synairgen announces that dosing has commenced with its inhaled interferon beta product in US Government-funded NIH ACTIV-2 trial in COVID-19 outpatients

Southampton, UK – 15 February 2021: Synairgen plc (LSE: SNG), the respiratory drug discovery and development company, today announces that dosing has begun in the inhaled interferon beta formulation (SNG001) sub-study of the ACTIV-2 Phase II/III trial, evaluating patients with mild to moderate COVID-19 symptoms not yet requiring hospitalisation.

Richard Marsden, CEO of Synairgen, said: “We are delighted that our inhaled interferon beta formulation has been entered into this US Government-funded Phase II/III study and that dosing has now commenced. With mutations of COVID-19 now emerging, and the concern that mutations may render the vaccines less effective, the need for broad spectrum treatment options remains very high. Our product is a potentially effective treatment as it is a virus agnostic and, we believe, strain agnostic antiviral, which is easy to use in the hospital or home setting. We look forward to tracking the progress of the ACTIV-2 trial alongside our other COVID-19 trials.”

As announced by Synairgen on 25 January 2021, ACTIV is a public-private partnership to develop a coordinated research strategy to speed up the development of the most promising COVID-19 treatments and vaccines. ACTIV-2 is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), one of the National Institutes of Health, and is led by the NIAID-funded AIDS Clinical Trials Group (ACTG). 

If an investigational agent shows promise by demonstrating safety and reducing COVD-19 symptoms through 28 days following administration, the ACTIV-2 trial is designed to expand seamlessly from a Phase II to a Phase III study to gather additional critical data from a larger pool of volunteers without delay. Phase II sub-studies enrol up to 220 volunteers, while exact enrolment size of Phase III sub-studies will vary depending on mode of administration of the investigational agent. The adaptive nature of the ACTIV-2 trial allows for comparison of multiple interventions with a shared group of placebo recipients. In addition to safety and symptomatic efficacy signals, the sub-studies in ACTIV-2 assess whether an investigational agent can reduce the amount of SARS-CoV-2 virus detectable in the nasopharynx.

For more information on the ACTIV-2 study, please visit www.riseabovecovid.org, or visit ClinicalTrials.gov and search identifier NCT04518410.

Synairgen is also running an international 610 patient Phase III trial, which is progressing well, assessing the efficacy of inhaled interferon beta in hospitalised patients with COVID-19. The Company also recently completed recruitment of a 120 ‘at-risk’ COVID-19 patients study evaluating SNG001 as a treatment for use in the home setting, results are expected on track in Q2 2021. 

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