Trial of Covid-19 drug given via inhaler ‘very promising’, say scientists | Coronavirus outbreak

Trials of an experimental drug inhaled by patients have found a significant reduction in hospital patients with Covid-19 needing to be put on a ventilator or dying from the disease, according to researchers

The drug, called SNG001, is delivered via an inhaler and is based on interferon-beta – a protein produced naturally in the body that plays an important role in coordinating the body’s antiviral response.

Now researchers have announced the results of an initial trial, finding the odds that patients treated in hospital with Covid-19 will either go on to need ventilation, or die, were 79% better among those given SNG001, compared with those given a placebo.

What’s more, the team behind the trial say those given the drug were just over twice as likely to show “no limitation of activities” or “no clinical or virological evidence of infection” during the 16-day study period – in other words, the chance of recovery was boosted, while those given the drug also showed a reduction in breathlessness.

Tom Wilkinson, a professor of respiratory medicine at the University of Southampton and chief investigator of the trial, told the Guardian the results were promising.

“The initial results are very positive and provide a strong platform to take this drug forward in clinical development, working closely with an international regulatory framework to try and get this drug into patient care as soon as is possible,” he said, adding that the drug can be manufactured at scale.

SNG001 is produced by the Southampton-based biotech firm Synairgen, a spin-out company from the University of Southampton, with University Hospital Southampton the lead centre for the trial, which involved a total of nine UK hospitals.

The trial, which was given the green light in March, involved about 100 patients who had been admitted to hospital with Covid-19. While half were given SNG001, the other half were given a placebo – neither the patients nor the doctors were aware at the time who was in which group.

Patients were given the drug for up to 14 days, with post-treatment data collected on days 15 and 16, and patients further tracked up to day 28. Over the course of the trial, three patients in the placebo group died; there were no deaths among those given SNG001.

Injections of beta-interferon are already used to help treat multiple sclerosis. However, SNG001 was formulated to allow the drug to be administered through inhalation – an approach originally developed to treat the lung disease chronic-obstructive pulmonary disorder (COPD).

The Southampton team quickly realised the formulation might also bring benefits for Covid-19 patients: not only do patients with worse symptoms tend to be those with a deficiency of beta-interferon, said Wilkinson, but it appears the coronavirus itself suppresses the body’s production of beta-interferon.

“A combination of those two effects, we think, has led to the severity of disease in certain populations, and hence why this drug might have a double, synergistic, effect – patching over the natural immune response and reducing the ability of the virus to subvert innate immunity,” said Wilkinson, adding that inhalation of beta-interferon means the drug is delivered directly to the lungs, where the virus is replicating.

The team is also conducting a trial of SNG001 in Covid-19 patients in the community who are at increased risk of severe disease. Wilkinson said they are hopeful the drug could not only reduce the chance of such patients becoming gravely ill, but could also speed up their recovery, noting that even among mild cases of Covid-19, some people have reported symptoms that go on for months.

SNG001 is not the first drug to show promise in treating coronavirus patients: a cheap steroid called dexamethasone has previously been shown to reduce deaths in those requiring help with breathing, while the antiviral drug remdesivir cuts recovery time.

But Wilkinson said that while remdesivir is thought to be focused on coronaviruses, SNG001 has a more general effect, meaning it may also benefit patients with “winter viruses” such as flu.

While others say the results are promising, some experts have urged caution, noting that the full findings have not yet been published – meaning the way the trial was conducted and analysed cannot be investigated. What’s more, the trial only involved a small number of patients.

But Danny Altmann, a professor of immunology at Imperial College London, welcomed the findings.

“This is promising and interesting, adding to the positive news about use of dexamethasone,” he said. “Here, in a well-designed trial, it seems to be the case that a very similar drug [to beta-interferon] can tip the scales against the most severe [Covid-19] disease.”

Source: https://www.theguardian.com/world/2020/jul/20/trial-of-covid-19-coronavirus-drug-given-via-inhaler-sng001-very-promising-say-scientists