Synairgen plc - Inclusion in US ACTIV-2 trial
('Synairgen' or the 'Company')
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
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.
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
Information within this announcement is deemed by the Company to constitute inside information under the Market Abuse Regulation (EU) No. 596/2014.
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Notes for Editors
Synairgen is a clinical-stage respiratory drug discovery and development company founded by University of Southampton Professors Sir Stephen Holgate,
Synairgen's differentiating human biology BioBank platform and world-renowned international academic KOL network has broader applicability for lung viral defence in other respiratory disorders including asthma and COPD. Synairgen is quoted on AIM (LSE: SNG). For more information about Synairgen, please see www.synairgen.com
COVID-19, caused by the SARS-CoV-2 virus, is a global threat and there is an urgent need to assess new treatments to prevent and effectively treat the severe lower respiratory tract illness that can occur with this disease. Older people and those with co-morbidities such as heart and lung complications and diabetes are at greatest risk of developing severe or fatal disease.
SNG001 (inhaled Interferon beta) applicability to COVID-19
Interferon beta ('IFN-beta') is a naturally occurring protein, which orchestrates the body's antiviral responses. It is used widely systemically for the treatment of multiple sclerosis and is a safe and well tolerated drug. There is growing evidence that deficiency in IFN-beta production by the lung could explain the enhanced susceptibility in 'at-risk' patient groups to developing severe lower respiratory tract (lung) disease during respiratory viral infections. Furthermore, viruses, including coronaviruses especially SARS-CoV-2, have evolved multiple mechanisms for suppressing endogenous IFN-beta production in the lung thereby helping the virus to evade the innate immune system. The addition of exogenous IFN-beta before or during viral infection of lung cells in vitro either prevents or greatly reduces viral replication to reduce the severity of infection and accelerate recovery. Recognising the importance of achieving high concentrations in the lung where SARS-CoV-2 exerts most of its tissue damaging effects, Synairgen's SNG001 is a formulation of IFN-beta-1a for direct delivery to the lungs via nebulisation. It is pH neutral, and is free of mannitol, arginine and human serum albumin, making it suitable for inhaled delivery direct to the site of action. Phase I and II trial data have shown that SNG001 activates lung antiviral defences as measured in sputum cells, and that SNG001 has been well tolerated in approximately 280 asthma/COPD/COVID-19 patients to-date.
The results were published in The Lancet Respiratory Medicine: "Safety and efficacy of inhaled nebulised interferon beta-1a (SNG001) for treatment of SARS-CoV-2 infection: a randomised, double-blind, placebo-controlled, phase 2 trial". Monk, P D et al.,
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