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

Press release

Synairgen plc
(‘Synairgen’ or the ‘Company’)
                                          

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.