Interferon beta, an approved and widely used cytokine in injectable forms, soon appeared as a possible treatment for Covid-19. A British biotechnology now says that its inhaled formulation of the drug helped hospitalized patients recover and reduced their risk of worsening.
It is a small study that involved only 101 patients and missed some endpoints, but Synairgen said the results could indicate a “breakthrough.” If true, that would also mark serious validation for a medication that AstraZeneca once authorized but eventually abandoned as asthma therapy.
First, the positives:
- Patients in the SNG001 group saw their risk of requiring ventilation or dying reduced by 79% compared to those receiving placebo, with a marginally positive p-value of 0.046.
- They were also “more than twice as likely to recover,” to the point where they can continue their daily lives despite infection, although the difference here was not explained (p = 0.043).
Stephen HolgateAlthough the company did not use exact wording, these results appear to align with the primary endpoint in a test publication, which measures clinical improvement during the 16-day dosing period on an 8-point scale. No further details were provided on how patients improved or worsened along that scale.
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Another secondary endpoint was highlighted, while others fell short.
Shortness of breath, a serious symptom designed to be evaluated in conjunction with cough and sputum, was “markedly reduced” for patients receiving the drug (p = 0.007). Cough and sputum numbers were not available.
Furthermore, Synairgen noted, three participants died after being randomized to placebo, compared to zero deaths in the SNG001 group, not that they can draw any conclusions from it.
SNG001 works by sending high local concentrations of interferon beta, a “natural antiviral protein,” to restore the lung’s defense against the virus, according to Stephen Holgate, a professor at the University of Southampton who co-founded Synairgen.
Richard MarsdenBut the trial, which was conducted at 9 sites in the UK, found that patients who already needed oxygen on admission did not appear to benefit as much. The “numerical advantage” in the probability of hospital discharge did not translate into a statistically significant gain, with the median time to discharge in the SNG001 group at 6 days and the placebo group, 9 days (p = 0.096) .
Synairgen also wanted to highlight that patients seemed to be more likely to recover at the end of treatment if they were taking the drug, although again it was not statistically significant.
What does this all mean? The company is conducting additional analysis and has previously said that fundamental proof would be needed. Marsden said they are now working with regulators and other groups to “move this possible COVID-19 treatment forward as quickly as possible.”
It is unclear how the data and those from a follow-up trial would fit interferon beta administered in more traditional and commercially available ways. These are being tested in combination with the HIV drug Kaletra in both the UK RECOVERY trial and the WHO-led SOLIDARITY study, two of the largest master protocols organized to drop a list of potential Covid-19 drugs. .
A study conducted in Israel, published days ago, concluded that although beta interferon “did not change the time to reach clinical response, adding to the standard of care significantly increased the discharge rate on day 14 and decreased mortality at 28 days” .
Before the pandemic spread, Synairgen had been testing SNG001 in patients with chronic obstructive pulmonary disease. In 2014, AstraZeneca obtained the asthma drug license and started a study, only to stop it in early 2016 after determining that an overall low number of exacerbations among asthma patients recruited in that cold season would make it difficult to see if they were actually could reach the primary end point that had been established.
“When we have collected cells from COPD and asthma patients and the elderly … we found that their lung cells do not respond very well to viruses,” Marsden said. Endpoint News in a previous interview “Also along the way we have always recognized that with an emerging virus, the drug could be used.”
Whether it will be adopted is an entirely different question that probably won’t take long to answer in the frantic R&D race for treatments.
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