Member Info for Scinv_temp

They won't roll out phase 3 copd after covid either. They can't do that with a closed p2 that did not show a clear signal. They have to redo the p2. They did the interim analysis to support what you said, non one forced them to close it, and they wouldn't have closed it if there was a chance in the future to recruit the rest of their patients to get an approval for a phase 3.

Their issue was that not many patients had serious symptoms, the same as with the asthma trial. Once again more of a stratification issue rather than a timing or treatment issue it seems

But even if you see what they said about it back in September it was obvious it did go as well as they were hoping. Anyway...

Even in September after the interim analysis they were still telling investors that it was paused

https://www.globenewswire.com/news-release/2020/09/08/2089903/0/en/Synairgen-announces-positive-data-from-interim-analysis-of-SNG001-trial-in-COPD-patients.html

I did say back then that I don't think it went that well anyway but people here were insisting I was confusing it with the asthma trial. Lol

Lol whatever.

This is what they feed investors

http://www.pmlive.com/pharma_news/positive_copd_data_for_synairgens_sng001_supports_covid-19_programme_1349008?SQ_DESIGN_NAME=2&

He added that, despite the encouraging data in COPD, this particular programme will be paused as the company’s “immediate priority” is to advance testing of SNG001 in COVID-19.
In September 2020 they communicated some results from the interim analysis but they still suggested the trial was "paused" even though clearly it did not look great

However, this is what they told the activ 2 people who they can't be fed with bs

"Originally, up to 120 patients in total were to be randomized during Part 2, however, due to the SARS-CoV-19 pandemic in 2020, the study was paused and an interim analysis was conducted of all currently available data in order to aid decision making with respect to the potential of SNG001 in treating and preventing COVID-19 symptoms. At this time, 109 (placebo, n=52; SNG001, n=57) patients had been randomized and following the interim analysis a decision was made to *close the trial*. "

"Although there was no statistically significant difference in total BCSS in this group over the treatment period, there was a trend towards improvement of the breathlessness component of the score, suggesting that patients may have recovered more rapidly if they received SNG001 rather than placebo. Viral infections had less impact on non-exacerbating patients and there were no significant treatment effects. Biomarker analysis showed that in the overall population COPD patients inhaling SNG001 had significantly increased markers of antiviral activity."

These are from the activ document in the background section for sng. The second part they also published in an RNS last september, as you can see there is a "suggestion" but not really conclusive. More importantly, in the first part above, they clarify that they initally paused the trial and then *closed* it *after* the interim analysis. They never told this to investors directly afaik but do correct me if I'm wrong. So they have to do it again but better. Once again, it seems to me if there were enough patients with exarcebation it would have been enough to apply for a phase 3 but now it does not seem to.

The trail is over, they didn't just pause it, it came to conclusion after the interim analysis. The interim analysis only provided some "suggestions" of efficacy.

Horby's tweet says SNG were the ones who wanted to go alone and Willkinson is not on BOD so I assume he just did not know what happened

They have to do new trials and select patients more carefully

No one would support a therapeutic that isn't available or take on the cost of development only to be sold back to them at inflated prices and start producing after approval. Remdesivir was an exception (and a scandal imo) in terms of efficacy and approval as it was such the climate then they needed something to tout (and Fauci had the hots for it) but they still had some quantity ready to go otherwise that wouldn't have gotten authorisation back in 2020 either.

The issue isn't with the science though, it never was.

Or rather, the last 12 nonths.

*not just the recovery

And it was just the recovery, remap cap etc were supported by govs, name one therapeutics company that wanted to do it themselves and got approval last year.

The recovery trial means the official UK effort for therapeutics. Also, so far the positive data we have is on hospitalised patients, the majority on oxygen. In addition, in the US and UK there was clearly a focus on hospitalised patients despite what the optimal time to give treatment appeared to be. Gilead did complain about this back then saying it would be best given earlier, the same rationale goes for monoclonal coctails. However all of them played ball and got tested first in hospitilised patients and in the end they got approval.

Doc I think there are many nuances of "NO" or "YES". I would say that asking for the details so late and then saying OK we'll start recreuiting in June, counts as a "MEH". Why is that the case, it is anyones guess.

Recruiting

It says "not recreuiting"

In theory, it could still close with full recruitment before they get to recruit anyone in India if the company chose to do so. But yeah, it seems not a priority to them at all. I wonder why, if I had to take a guess I would say that that is the earliest date that RM can send them the materials for 25 or so patients or that they saw the price and said, no thank you :)

Wilts, understood but yet this is the case. On one hand not every large fund might be allowed to invest in AIM companies or perhaps it will be restricted in how much relative to their assets they can innvest in AIM companies. But om the other, this is a £300M company, so it doesn't require huge amounts to have >3% ownership. Anyway, thanks for the list.