Gordon Stein, CFO of CleanTech Lithium, explains why CTL acquired the 23 Laguna Verde licenses. Watch the video here.
This was posted by nessab yesterday in reply to the testing thread, but very much deserves its own space on this board.
Anyone that's been following the science side of the company will recognise some of the authors and indeed, this looks to be genuinely groundbreaking research on auto-abs and covid.
The focus on ICU patients means inhaled INFb doesn't get a mention, but it does look to open the door for inf treatment for ICU patients that test positive for auto-abs - indeed the comment from the sprinter peer review notes that nebulisers can be configured for ventilated patients seems more relevant after reading.
https://annalsofintensivecare.springeropen.com/articles/10.1186/s13613-022-01095-5
The doc at the start of this thread is best top line summary one come across of what's in the bill.
It's worth keeping in mind that PPA bill had been on the table since April and beyond the funding, there are a host of operational and technical aspects that have just become law. This is one (of a fair few) that caught my eye
"Expands eligibility for the Qualified Infectious Disease Product (QIDP) designation to include biological products. "
https://www.sciencedirect.com/science/article/abs/pii/S0306987722002365
"Therefore, we hypothesize that IN administration of IFNß can be an effective and promising strategy to slow down cognitive decline in AD patients at least partly by reducing amyloid deposition and tau hyperphosphorylated protein accumulation, promoting anti-inflammatory response and anti-apoptotic pathways, increasing neurotrophic factor expression, activating mitochondrial biogenesis, modulating neurogenesis, and improving cerebral glucose metabolism."
https://www.sciencedirect.com/science/article/abs/pii/S0304394022005298
"Therefore, IFNß may be a beneficial therapeutic agent for relieving neuropsychiatric symptoms in AD-like neurodegenerative disease.*
" we can now develop new drugs for combination therapy and host directed treatments that strengthen our immune systems against multiple pathogens"
https://www.help.senate.gov/download/prevent-pandemics-discussion-draft-sxs-final
Published here:
https://academic.oup.com/ofid/article/9/Supplement_2/ofac492.1879/6903622?login=false
"When compared to placebo, SNG001 reduced the relative risk of common symptoms of long COVID (fatigue/malaise [RRR=35.4%]; dyspnoea [RRR=28.3%]; loss of smell and/or taste [RRR=61.4%])."
Well isn't this interesting....
New NHS guidelines for those most vulnerable to Covid includes:
"primary immunodeficiency associated with impaired type I interferon signalling"
https://www.gov.uk/government/publications/highest-risk-patients-eligible-for-covid-19-treatments-guide-for-patients/highest-risk-patients-eligible-for-new-covid-19-treatments-a-guide-for-patients#the-highest-risk-patient-groups
Would seem to bring those stated objectives of the UNIVERSAL trial in to focus
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.
Efficacy analyses were also performed in the PP population, which excluded patients whose treatment deviated from the protocol in a way that may have impacted evaluations. The most common reason for exclusion was not receiving at least two full doses of study medication in the first three days. The relative risk reduction in the patients who progressed to severe disease or death was 36% in the PP population rather than 26% in the ITT population, although this was not statistically significant. Furthermore, in the post-hoc subgroup analyses, conducted in patients with baseline clinical parameters associated with increased severe COVID-19 risk, differences in favour of SNG001 plus SoC were more marked than in the PP or ITT populations, with relative risk reductions in progression to severe disease or death ranging from 44.8% (p=NS) to 69.9% (p=0.046) when patients were grouped by age, presence of comorbidities, and poor respiratory function (i.e., oxygen saturation =92% and/or respiratory rate =21 breaths/min while on supplemental oxygen). This potential clinically important effect therefore needs to be confirmed in a future study adequately powered to assess this endpoint. The lack of impact on recovery contrasts with the results from the Phase II study of inhaled interferon-ß in patients with COVID-19 [23], conducted at the beginning of the COVID-19 pandemic (March to May 2020) before any treatments that had been evaluated in randomised controlled studies were implemented as SoC. Thus, SPRINTER differed from the previous study in that 18% of the included patients had been fully vaccinated, and that a large proportion were receiving corticosteroids (87%) and/or antivirals (19%). These improvements in SoC, together with changes in hospital practice, may have masked our ability to show a treatment effect on the primary endpoint. One of the consequences of these changes is that patients were discharged from hospital more quickly in the current trial. While in the Phase II study, the median time to hospital discharge in the subgroup of patients who were receiving oxygen by mask or nasal prongs (i.e., matching the population recruited into SPRINTER) was 9 days in the placebo plus SoC group (data on file), it was 8 days in SPRINTER overall, decreasing further to 6 days in the UK sites (where the Phase II study was conducted [data on file]; Figure S6). Improvements in SoC have also been reported by the RECOVERY Collaborative Group. Initially in the RECOVERY platform study, conducted in 2020, 28-day mortality was 23% in patients who received dexamethasone plus SoC [27], whereas in a later study, conducted in 2021, 28-day mortality in the SoC group (with 95% of patients receiving a corticosteroid such as dexamethasone) was 14% [28]. Similarly, the proportion of patients discharged from hospital within 28 days in these groups increased from 67% to 78% [27, 28]. The favourable safety and tolerability profile of SNG001 observed in the SPRINTER study was con
This seems like a good opportunity to share the below, which was included w the Activ-2 RNS on the 4th Oct
"Synairgen conducted a trial of SNG001 in high-risk, home-based COVID-19 patients (SG016) in which fewer patients treated with SNG001 were hospitalised (0/56) compared to placebo (2/58). In total across SG016 and ACTIV-2, 1/165 SNG001-treated home-based COVID-19 patients have been hospitalised."
Would love to see a bit of detail on the 1 patient hospitalised that received sng001
Maybe not "big" but the fact we've seen
Peer review of PASC published
Two new Presentations on the website
Public Confirmation of the Quality Director
All within 24hrs of the inclusion of the Prevent Pandemics Act in the US spending bill is pretty interesting
Data already covered by RNS but both look to give a 'full picture analysis" of SNG001 to date.
https://www.synairgen.com/investors/presentations
Had to have it confirmed by someone a bit more knowledgeable about these things, but the above is peer review for the PASC results from sprinter.
https://academic.oup.com/ofid/article/9/Supplement_2/ofac492.1879/6903622?login=false