Cobus Loots, CEO of Pan African Resources, on delivering sector-leading returns for shareholders. Watch the video here.
Based on the facts at our disposal - a company retaining and recruiting key positions and building its profile through social media engagement, presenting at important scientific and medical meetings, holding funding for at least another year BUT maintaining radio-silence on the commercial announcement front, i am fairly certain that something very positive is afoot that is either not quite at the stage of being ready to be announced or, more likely imo, is the subject of an NDA. I retain confidence in team SNG and don’t expect my paws to be buttered with RNSs when there is nothing that can be publicly said. As shareholders we have a right to material information about the company’s progress as and when it is material, not to meaningless tit-bits just because it’s the second Tuesday in the month.
Re-reading Dr Monk’s paper, “The Need - and Opportunity - to develop Broad-Spectrum Antivirals”, I am reminded of how different the respiratory viral infection landscape was a mere 36 months ago and how central to the changes Synairgen has been. Suddenly we live in an era where discussion of the possibility and the importance of rapid viral testing, the importance of innate immunity, the strategy of host-directed - and therefore virus/variant agnostic - therapeutics is commonplace. We recognise, as never before, the burden of viral respiratory illness at an individual and population level as well as the way it tests the resilience of health services.
We have seen the strengths and weaknesses of mono-therapies, notably mono-clonal antibodies, and of vaccination strategies and the early willingness of decision makers to jump on the bandwagon of these interventions to the exclusion of support for other emerging therapeutic strategies. We are now seeing an emerging awareness that this stool needs a 3rd leg to constitute an effective overall interventional strategy. And we are seeing an awareness that part of that strategy must be preparedness for future new and different viral pandemics, necessitating governmental motivation and relevant investment, including stockpiling of appropriate therapeutics.
The Covid pandemic has moved Synairgen and its agenda centre stage in a way scarcely imaginable in December 2019. The pandemic has provided an environment in which Synairgen and its investigation of SNG001 have transitioned in a remarkably short period of time from the work a virtually unknown academically-led venture outside the infamous “golden-triangle” of Oxford, Cambridge and London to a company contributing and, to some extent leading, this international endeavour. This has not been without cost and some mistakes and mis-steps have occurred along the way. That is the nature of bio-medical research and drug discovery. The challenges of getting SNG001 over the conclusive demonstration of efficacy line and the commercialisation line have yet to be met.
Synairgen has risen to the challenge remarkably for an enterprise of its size and nature over these short 36 months. They have more to do. To all appearances their efforts and the results to date of their investigative programme are taken seriously in governmental, regulatory and industry circles. Key opinion leaders like Rick Bright are not shy about expressing support for the interferon thesis in general and SNG001 in particular
As the Covid pandemic transitions into just another endemic respiratory viral problem like influenza, RSV, etc, and as public weariness with booster vaccination, fuelled by rational or irrational fears regarding vaccine safety in the long term, becomes ever more pronounced, the environment will continue to morph in favour of the need for host-directed micro-organism agnostic therapeutics. With prudent management and support there is everything to play f
The jargon in the ad is very current, “ potentially the first host-targeted broad-spectrum antiviral treatment delivered directly into the lungs. Synairgen is led by a team of industry experts and world-renowned academics, dedicated to creating pandemic-ready respiratory treatments we can all believe in”
I see from one of the two presentation posted on the SNG website today that, in the ACTIV-2 phase 2 study, 1% of patients in the SNG001 group were hospitalised compared to 7% in the placebo group. I’m not aware that this has been reported previously. Small numbers and not statistically significant but still ….
LC affects a multitude of tissues in the body either because of chronic persistence of the virus in them or long term effects of viral infection there - or both.
The USP of nebulised SNG001 is the concentration of its therapeutic effect in the lungs and avoidance of effects and side effects elsewhere.
If 001 has an effect in controlling LC it is through its effect on the acute respiratory phase of the illness. A trial in established LC would be expensive, lengthy and, IMO, futile. Further evidence of reductions in the symptoms of LC in SPRINTER would be important confirmation of the beneficial impact of 001 in the acute phase of the illness and, perhaps particularly so, in sub-groups of patients, part of that effect being a diminution in the number of cases progressing to some or all forms of LC and/or the severity of their LC symptoms.
I was in this trial. Never had such a spectacular reaction to a vaccine in my life! But glad I got the active agent. To to question: yes it potentially affects SNG to the extent that there should be fewer acute respiratory viral infections due to RSV around to the extent of this vaccine uptake and in the event that 001 is approved as a broad spectrum anti-viral agent. But the effect would be at the margin, not hugely significant; plenty of other respiratory viruses to be getting on with.
I am of the same opinion regarding the face-validity of a meta-analysis or simple pooling of the data from the home trial and ACTIV-2. It is also certain that either approach would yield a highly significant positive result.
I would be astonished to learn that the exercise has not already been carried out by Synairgen or their contracted statisticians. They must be wondering how best to manage this information - in discussions with BP, with regulators and/or discussions with PT managers. Or else, they are already down the path with one, two or all three parties.
Radio-silence is deafening, though
The new information in Richard’s AMR presentation strongly reinforces the earlier efficacy messages regarding SNG001 as an agnostic antiviral agent. Small numbers, I know, but potent signals on viral clearance and bacterial supra-infection prevention (CRP and purulence suppression). For me this is very welcome news indeed.