RE: SPRINTER Peer Review22 Dec 2022 22:47
observed in the SPRINTER study was consistent with the previous studies in patients with COVID-19, asthma and COPD [1921, 23]. A similar proportion of patients in the two treatment groups experienced adverse events, most of which were mild or moderate in severity, and not considered either treatment-related or serious. In terms of serious adverse events, pulmonary embolism only occurred in the placebo plus SoC group, an observation that is interesting as incidence of coagulation events are well documented for patients hospitalised with COVID-19. Given the observation, which would need to be confirmed in further studies, that patients with poor respiratory function may gain greater benefit from SNG001, a potential limitation of the study is that patients requiring non-invasive ventilation, high-flow nasal oxygen therapy, endotracheal intubation or invasive mechanical ventilation could not be dosed. However, the nebuliser can be used in different configurations that should enable these patients to be dosed in future studies (supported by appropriate dose selection studies, taking into account drug delivery to the lungs). In addition, the timing of initiation of interferon treatment has been the subject of debate, with suggestions that later initiation could be less effective. Patients were excluded from the study only if the prior duration of symptoms was =3 weeks (although a recent positive SARS-CoV-2 virus test was required, and most patients had a duration of symptoms of less than 10 days). In the previous Phase II study, in which SNG001 was more effective than placebo, the median duration of symptoms at recruitment was similar to the current study [23]. This suggests there is a wide window for initiation of treatment with SNG001. In conclusion, although the primary objective of the study was not met, there were signals in the key secondary endpoints which suggest that SNG001, on top of SoC, may have prevented progression to severe disease (although differences were not statistically significant). In addition, SNG001 was well-tolerated with a favourable safety profile, validating the route of administration. When combined with the results of the previous Phase II study, these findings provide a rationale to continue investigating SNG001, not only in hospitalised patients with COVID-19 (in the context of ongoing virus evolution and likely emergence of new variants), but also more widely in patients with severe seasonal viral lung infections, due to the broad-spectrum and variant agnostic antiviral activity of interferon-ß.
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