The latest Investing Matters Podcast with Jean Roche, Co-Manager of Schroder UK Mid Cap Investment Trust has just been released. Listen here.
COVERAGE trial link:
https://clinicaltrials.gov/ct2/show/NCT04356495
COVERAGE is trialling nebulised IFN beta 1b so not SNG001. The question is whether this somewhat shoe-string French initiative has enough steam to negatively impact on the progress of Synairgen. The study numbers are comparable to the SNG P2 study and one would expect that, in the normal course of events , would have to be followed by a formal P3 before the formulation was licensed. However, there is, as far as I am aware, no commercial pharma sponsor for the “product” to fund such an initiative. It is cooked-up in hospital pharmacies using injectable INF.
If the current trial is successful, who knows whether the French government could promote its use as an unlicensed preparation in the emergency situation of the pandemic. How would it stack up against SNG001 in safety and efficacy? Would it infringe Synairgen’s patent protections? Would current animosity between the UK and EU/France encourage the French to go ahead anyway? Interesting questions.
This confirms that the only non-UK centre signed up is in Amarillo, Texas, and that it is not yet recruiting. Am I alone in thinking that this was not the pace of multi-national progress I was anticipating? Furthermore, it is interesting to note that there is a virtually total absence of participation in Sprinter in London and the Home Counties. I wonder why? It increasingly looks like most of our eggs are in the home-treatment basket, a point made in Sir Stephen’s most recent panel discussion last week, for the immediate term, at least.
Doc, Ferrari’s post appears to relate to a Serbian publication dated 2 February. If this is so, then it is very good news. Hard information that there were 40 recruits in the UK arm of P3 a fortnight after the start-up date with the prospect of 3 Serbian sites opening up within days. No?
Here is a link to a page with an abstract of the journal article in English. You can also access the full article on this page via the “PDF” button.
https://jvi.asm.org/content/early/2021/01/28/JVI.02415-20.long
Remember, Synairgen submitted a patent application last August for the use of SNG001 with corticosteroids in COPD and Covid-19. This Nature paper sheds further light on the interplay between the two molecules. It was a retrospective study with all of the contraints that that implies but good supportive information in any case.
I for one do not want vaccine failure. I know that the majority just want to put Covid behind them and get back to some kind of normality. Those who will be living with the reality of Covid for several years to come, however, will be the respiratory physicians, ITU specialists and other clinicians who will, IMO, be dealing with significant numbers of cases, particularly in the winter months over several years. We may not be talking about huge numbers by the standards of the current pandemic but we are talking about a significant and ongoing level of need, by no means fully met by current therapeutics. And that is before stockpiling in preparedness for a future pandemic situation caused by a possible variant virus breakout. The key question remains whether SNG001 demonstrates an outstanding efficacy at one or more stages in the disease. We will have answers to this in weeks. I remain optimistic, based on the science.
This meta-analysis relates to IFN beta 1a used subcutaneously in 5 randomised controlled studies. The fact that it confirms a benefit at a statistically significant level is good news, supporting the fundamental contention that IFN beta has a beneficial effect in Covid disease. What we know is that, when given by inhalation the beneficial effect is enhanced and the potential for side effects is diminished. So, I take great comfort from this paper which represents a further validation of the SNG001 thesis.
Apologies if posted before:
https://lemminginvestors.blogspot.com/
“If SNG001 gains FDA approval I seriously doubt Synairgen will survive as an independent entity, it will almost certainly be gobbled up by a larger pharmaceutical company. This is not just my opinion; it is the opinion of city sources. If correct, then Synairgen will command multi-bag status from and likely well ahead of Numis target valuation of £9.90p.”
Re the transition from ACTIV-2 phase-II to phase-III, I think that the key phrase in the RNS is “seamlessly expand”. This implies that there is a process of monitoring progress and that a go/no-go point is reached at about 200 subjects recruited (half of whom are generic controls). If the decision is taken to proceed at that point, the trial becomes P-III OVERNIGHT, as it were, still based on the original protocol, end-points, etc with some 100 subjects already under the belt. So, the timing of the transition is not critical. The fact of progression to P-III is.
.... and here is some information including the sites participating in ACTIV-2:
https://www.riseabovecovid.org/en/
Here is the link that confirms that, as of 10 February, only the SNG001 arm of the trial was under way, the other 3 candidates to follow. Of course one or all could be under way now - or not. It does confirm, though that we were ready to go.
Statement—Four Potential COVID-19 Therapeutics Enter Phase 2/3 Testing in NIH ACTIV-2 Trial The added sub-studies will test four interventions for safety and efficacy: SNG001, an inhalable beta interferon delivered by nebulizer, (Synairgen); AZD7442, a long-acting monoclonal antibody combination that will be studied as both an infusion and an intramuscular injection (AstraZeneca); and Camostat mesilate, an orally administered serine protease inhibitor that may block SARS-CoV-2, the virus that causes COVID-19, from entering cells (Sagent Pharmaceuticals). The first volunteer enrolled in the SNG001 sub-study on February 10. The other agents under study are expected to begin enrolling participants soon.
https://www.niaid.nih.gov/news-events/statement-four-potential-covid-19-therapeutics-enter-phase-23-testing-nih-activ-2-trial
.... forgot to mention the fact that there are 104 ACTIV-2 sites and, only 210 enrolments are required for the initial P2 phase; an average of just about 2 enrolments per centre. With the other 3 prospects apparently a tad behind SNG001 could we see enrolment within a week? Why not?
It is we shareholders that are sponsoring P3 worldwide through the November raise. US are certainly putting huge logistical support behind the at-home NIH Activ2 study, at a level and pace that would be hard to match for any small company operating alone. That kind of commitment and, hopefully, delivery at pace doesn’t come cheap. So thank you Dr Fauci, et al.
Statement—Four Potential COVID-19 Therapeutics Enter Phase 2/3 Testing in NIH ACTIV-2 Trial The added sub-studies will test four interventions for safety and efficacy: SNG001, an inhalable beta interferon delivered by nebulizer, (Synairgen); AZD7442, a long-acting monoclonal antibody combination that will be studied as both an infusion and an intramuscular injection (AstraZeneca); and Camostat mesilate, an orally administered serine protease inhibitor that may block SARS-CoV-2, the virus that causes COVID-19, from entering cells (Sagent Pharmaceuticals). The first volunteer enrolled in the SNG001 sub-study on February 10. The other agents under study are expected to begin enrolling participants soon.
https://www.niaid.nih.gov/news-events/statement-four-potential-covid-19-therapeutics-enter-phase-23-testing-nih-activ-2-trial
It’s official” - such sweet words. Even though we have known that this was in the bag for what seems like ages and didn’t doubt the veracity of the January RNS, it is great to see it in black and ****e on the ACTIV-2 website and to know that recruitment is actively under way!