RE: Did anyone see this week coming?9 Sep 2022 15:09
The trial will not be resumed, it was closed a few months after pausing it. They are just catching up with sample processing and data analysis.
Also beware of the "Marsden-speak", the viral load in samples was in the original protocol, the fact that they did post-hoc analysis means the endpoint as prespecified in the protocol did not show satisfactory results so they had to data dredge again. It could be that it just showed something with hrv in particular, which in itself is an interesting result which is definitely actionable, but what worries me most is the day 7 part. Was it just this particular day that showed statistically significant reaults? If that's the case, regulatory authorities will laugh this out, as a curve of efficacy is expected towards approval. To be fair they say nothing about approval, it's all towards informing future trials, as the company says in the RNS.
Similarly, the secondary bacterial infection datapoint in all likelyhood was just a numerical difference of no statistical significance, otherwise they would be saying otherwise.
"Viral clearance from the lower respiratory tract
Sputum samples were collected where possible at study visits conducted during and after the 14-day dosing period. Assessment of viral clearance focused on the most frequently detected virus, human rhinovirus (HRV), which accounted for approximately 50% of infections. The results suggest that HRV was cleared more rapidly in patients treated with SNG001 than placebo with a statistically significant difference in the proportion of patients with detectable HRV in sputum at Day 7 (post hoc analysis).
Markers associated with secondary bacterial infections
In COPD exacerbations, sputum purulence and elevated levels of serum C-reactive protein (CRP) are associated with the presence of bacteria in the lower respiratory tract. In the second week of treatment, a greater proportion of patients in the placebo group had purulent sputum or elevated serum CRP."