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Prof. Sir Stephen Holgate CBE, Medical Research Council Clinical Professor of

Immunopharmacology at the University of Southampton and Co-Founder of Synairgen, said: "Emerging variants of SARS-CoV-2 are of great concern as they may negatively impact on the effectiveness of current vaccines and therapeutics. These data are not surprising, and confirm the broad-spectrum antiviral activity of SNG001, which has shown activity against a range of respiratory viruses such as RSV, rhinovirus, adenovirus and influenza, and reassuringly confirm its activity against these SARS-CoV-2 variants which is important in the context of our ongoing Phase III trial in hospitalised patients and the future use of this drug against SARS-CoV-2 and other emerging viral threats."

Richard Marsden, CEO of Synairgen, added: "As expected, these data confirm that SNG001 is a broad-spectrum antiviral product, now also demonstrating applicability against SARS-CoV-2 variants. The SARS-CoV-2 virus suppresses the production of the essential antiviral protein IFN-beta to evade the host immune system; it is therefore to be expected that when IFN-beta is reintroduced into an infection experiment that the host cells are able to repel the virus.

"Alongside vaccines, our lines of defence for this pandemic and future outbreaks rely in part on access to effective antivirals with broad-spectrum activity against a range of viruses and variants. The current focus on the Indian variant demonstrates how concerned Governments are about the risk that a variant may render the vaccines less effective, and we are pleased to see initiatives being put in place to accelerate and support development of antiviral therapeutics as a backstop for patients who are admitted to hospital. We are pleased to report that we will start dosing patients at trial sites in India in our Phase III study imminently."

Synairgen has previously shown the antiviral activity of SNG001 in cell-based assays against key respiratory viruses, including rhinovirus, the most frequent cause of the common cold, RSV and influenza, including pandemic H1N1 2009 and H5N1 'bird flu' strains and SARS-CoV-2. SNG001 also showed broad-spectrum antiviral activity in man with clinical efficacy seen in clinical studies conducted in asthma and COPD patients with respiratory viral infection caused by common cold (e.g. rhinovirus, RSV, parainfluenza, adenoviruses, HMPV and seasonal coronaviruses) and flu viruses.

Reminder-

Synairgen announces results of in vitro studies showing antiviral activity of interferon beta against key SARS-CoV-2 variants

- SNG001 shows potent antiviral activity against SARS-CoV-2 variants
- Demonstrates broad-spectrum antiviral activity of host-targeted antiviral treatment delivered directly into the lungs

Southampton, UK - 24 May 2021: Synairgen plc (LSE: SNG), the respiratory company developing an inhaled formulation of interferon beta (SNG001) as a broad-spectrum antiviral for the treatment of severe viral lung infections, currently in COVID-19 trials in the hospital and community settings, today announces results from in vitro studies showing the antiviral activity of SNG001 against two SARS-CoV-2 variants.

Interferon beta ('IFN-beta') is a naturally-occurring protein, which orchestrates the body's antiviral responses by triggering the production of hundreds of antiviral proteins which act across the viral replication cycle to confer broad-spectrum antiviral activity. Nebulised SNG001 is delivered directly into patients' lungs, the primary site of virus infection, to prevent severe lower respiratory tract illness caused by the SARS-CoV-2 virus.

Since the first outbreak of COVID-19 in Wuhan, a number of variants of SARS-CoV-2 have emerged that are spreading globally.(1) Changes to the virus have the potential to make it more transmissible or to enable the virus to evade the immune system, prompting concerns that some vaccines and therapeutics developed to prevent/treat COVID-19 may become less effective against certain variants. So-called "variants of concern" such as the "Kent", "South African" and "Indian" variants(2,3) have potential to halt or slow the reopening of societies despite progress with vaccination programmes. In the UK, alarm about the rapid growth of the so-called "Indian" variant has led to speculation that authorities may need to bring in renewed restrictions.

In vitro experiments were conducted at Viroclinics-DDL in the Netherlands to confirm that SNG001 had activity against the B.1.1.7 ("UK or "Kent") and B.1.351 ("South African") variants. In these experiments, Vero E6 cells were treated with SNG001 prior to and after infection with SARS-CoV-2. 16-24 hours after infection, the presence of SARS-CoV-2 viral proteins was determined using an immunostaining method. SNG001 potently reduced virus to undetectable levels in cells infected with "Wuhan-like" (virus strain: Germany/BavPat1/2020), the UK/Kent variant and the South African variant. Concentrations, readily achievable following inhaled delivery of interferon beta, that gave 90% inhibition (IC(--) (90) ) were 3.2, 4.0 and 3.4 IU/mL respectively.

The fact SNG’s phase 2 trial enabled it to raise some £87m at 175p and get onto ACTIV-2 tells me it wasn’t too bad!

Lest we forget -

The odds of developing severe disease (e.g. requiring ventilation or resulting in death) during the treatment period (day 1 to day 16) were significantly reduced by 79% for patients receiving SNG001 compared to patients who received placebo (OR 0.21 [95% CI 0.04-0.97]; p=0.046).
Patients who received SNG001 were more than twice as likely to recover (defined as ‘no limitation of activities’ or ‘no clinical or virological evidence of infection’) over the course of the treatment period compared to those receiving placebo (HR 2.19 [95% CI 1.03-4.69]; p=0.043).
Over the treatment period, the measure of breathlessness was markedly reduced in patients who received SNG001 compared to those receiving placebo (p=0.007).
Three subjects (6%) died after being randomised to placebo. There were no deaths among subjects treated with SNG001.

Clearly should have a part to play. Phase 2 completion due mid October and I’d expect SNG001 to have been granted EUA and on ACTIV-3 before then.

From your link - by 7th day 80% of those who received lamda had an undetectable viral load versus 63% of those who received placebo.

Impressive results snd let’s see if it’s replicated in phase 2 and phase 3.

So many such papers on Inferferon Beta.

FYI the phase 2 completion date is expected 15 October this year. Let’s see if the results are as impressive as SNG’s hospitalised phase 2 trial. Sure we’ll be on ACTIV-3 and I suspect orders due to EUA before then.

Seems to work better, do you have info on its phase 2 trial that isn’t published?

I hope it helps too but surely delivering beta direct to the lung rather than injecting lamda would be more effective.

Worth a listen -

https://www.kantar.com/inspiration/future-proof-podcast/11-why-should-advertisers-embrace-in-content-advertising?utm_source=twitter&utm_medium=social&utm_campaign=futureproof

Agreed, positive news is needed to regain momentum. Potential clearly massive but after a poor H1 the CEO needs to ensure his team is executing and these $500k deals under negotiation are closed.

Ndn71, you say a few orders. How the hell do you know how many? Just like your assumption the CV wasn’t independent. Always a negative slant.

We have a new one on the book so we now have 9.

Over there and here to be fair!

What a stupid headline, asking for trouble. MSYS is flat and DVRG less than 1% up. Higher but a headline asking for trouble.

The price was 26.05p so definite sells. Good the MMs took them.

Thanks ES

I thought Medusa19 was logistics only and not a manufacturer? Their website also suggests this. Why does anyone think different?

Exactly Matml74 it isn’t a competitor for SNG001 as it is a prophylactic treatment so more of a competitor to vaccines.

Yep AZN like a vaccine not a therapeutic. Odd sell off this AM. It’ll bounce for sure and even more so with FOMO as news imminent here.

Being a pedant but if most roles are sales and marketing it says they are looking for growth. I suspect MicrotoxPD will need sales and marketing and I suspect PD will dominate the market. Here’s hoping.

Sangijuelas you make it up as you go along. Abbott's rapid antigen COVID-19 test cleared in Europe for at-home, direct-to-consumer sales