Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
The latest RNS suggested that the company aims to have 100000 treatments produced per month in 2021, but does anyone know of the current manufacturing capacity, especially for the end of this year, now that the MAPs are opening in the countries?
Is the finished product made in the UK?
@JoeyDiamond - Applications in Germany to BfArM for pre-approval access typically take about 28 days (that includes dealing with any notice of deficiency in the application). So look at end Oct for approval (if they haven't already submitted). Then I suspect importation will be relatively straightforward (a matter of days). Can anyone confirm the drug is made in the UK?
UK will be simple, as if the drug is made in the UK, a standard notification to the MHRA is required for each patient, but otherwise no notification of importation of drug. As I say, from now on in, there will be plenty of people talking about SNG-001 in plenty of languages!
@pmjh. It is illegal to advertise the use of medicines pre-licence and so proactive mailings are not allowed. That being said, this has had a lot of press coverage and doctors are and will be talking to each other about it and so it doesn’t really need much advertising or promotion.
@davethedumplin - the ATU is made up of many parts. Doctors can make a request to the health authorities at any time for individual patients. The cohort ATU is the one we are all waiting for. The cohort ATU, as in the name will open the MAP for defined groups of patients. I don’t know if it will be as early as the 15th Oct but it will be soon.
All countries have different regulations around Pre- approval access, so don’t be surprised to hear about further openings. More positive news to come.
Nolupus - yes they can and many drugs are charged for in the French ATU. I've only worked in this area for a number of years. Believe what you want. But in the spirit of doing your own research, just google ATU and France and read for yourself.
The financial impact of making this sort of supply is inconsequential to the benefit it will bring to patients, to the doctors and to the company.
Nolupus, that is incorrect. They can charge in some countries e.g. France. But the bigger payback will be the advocacy they will generate through the MAP.
Robortsmith - I also thought that it may be quicker to open sites in new countries, but the effort and time involved is quite extensive. Typically, to open any new site in any new country will take about 6 months from start to first patient in (not taking into account any translations and validation of any reporting scales required). Their analysis must have shown that it's better to wait it out in the UK. I suspect the Phase III will be multi-country, if it isn't, then I'd be worried!
The deal for the MAP with clinigen is spot on. This will be the first of many early access programmes we hear about. I've seen posts about loss of sales, not seeing regulatory news etc. This will come, it takes time!
Firstly, and most importantly, it gives those patients most in need access to the drug without a product licence, it will help to save lives.
Secondly, in doing so, clinicians around Europe, not just the UK will be able to experience the positive clinical effectiveness of SNG-001. You do not have more powerful advocates to licence and use treatments than a wave of doctors and patients who say it saves lives
Thirdly, yes, SNG will pick up the costs in most countries for this, but remember, it will be COGS in the large part and because of points above, it will be more than worth it. Some country pre-licence access programmes do allow for charging e.g. France with their ATU. This CAN be revenue generating. SNG will be within their rights to charge for MAP in France and in fact the health authorities encourage data capture in the cATU to help with funding decisions (not that this will be a problem), but it all helps.
Overall, today's announcements are super positive. I can see further early access announcements soon e.g. EUA, EAMS etc. in addition to news about the regulatory agreed path and the Phase III trial news.
I did have a concern about the home trial not recruiting well, and I really thought it would be prudent to open sites in countries where the incidence is higher, but I think the company must have done the analysis and concluded that time will not be saved in opening new sites vs. waiting for the UK sites to pick up.
Overall, really pleased with the news and more to come I'm sure.
Agreed C_H. Capacity shortages are a global problem. I can only see repeated and new orders coming in. Reassuringly, I really liked the note that NCYT have capacity to supply for these orders (and others no doubt)!
Agreed, people are panicking about a potential second national lockdown, rather than anything more sinister regarding product development. Science takes time, don't rush it, otherwise you end up with a poor product that then is withdrawn a short while after launch.
The panic is about how extensive or not the rule changes may be. We don't have anything more effective than social distancing measures, until testing capacity and capability improves or treatment improves or vaccines are widely available. Everyone is now waiting for BJ to make his announcement (hopefully not long). Testing will still be one of the main ways out of this, no need to panic.
Unfortunately the reporting around a lot of these newer tests is opaque at best and done in their own laboratories, nothing wrong with that if you report and publish in a transparent manner and follow up with independent validation. The iabra tech is new and looks quite promising, but they have to do a much better job at reporting their data. I can't make sense of it too, at least not without making assumptions about their methodology.
Another one here, reported as the first at home rapid test! Although, again, not launched, registered etc. Still undergoing validation. Looking at it, they seem to be using a mix of technology, LFT and AI from visual inspection. For me, rather than increase accuracy, it may mean that you're more likely to get the test wrong. Home use validation should be reported, they state 90% sens and 100% spec. Let's see if this holds true for any labels they may get.
https://www.axios.com/gauss-cellux-first-full-at-home-rapid-coronavirus-test-355c2821-b06a-4e0d-a833-ff2e5cf0f10c.html
As said by others, the two could be trialled together but I would rate such a study less useful than combining with remdesivir. Dex was shown to be most effective in ventilated patients, you can't inhale SNG-001 whilst on a ventilator. Depending on lung capacity, it still may be of effect in oxygenated patients, but I'd say this is a risk. Dex works more on the adaptive immune over-response later in infection, rather than on the innate immune response, early in infection, like SNG-001.
A combo trial with remdesivir would be more worthwhile exploring.
gkb - I doubt we will have many vaccines by year end, maybe one, based on early data too and an EUA. It will take at least 3 years to vaccinate 7 bn people, even if one is found to be effective. In that time, what do you do for the many who will be infected and need an SNG therapy? I am not in the slightest worried over timelines. It's not about the perfect dataset. It's about letting the agencies and SNG do their job, they will be working fast to get a pathway forward as quick as possible.
PS - don't expect Fauci to mention anything that isn't an American discovery. All countries have adopted a jingoistic vibe to what they are doing to 'help the world'. When this is ready, he will announce it from the rooftops that the FDA have done something great by allowing EUA.
gkb - it is about that balance. The substance is naturally occurring, like insulin or potassium or any other synthetic manufactured to mimic a naturally occurring substance in the body. These aren't herbs and potions though, any manufactured pharmaceutical product has to be made to a consistent standard, and as they are speaking to other manufacturers to boost production, regulatory authorities will want to know the product can be consistently manufactured to the same high spec with the same quality controls in place before approving for anything.
Same goes with the clinical data, what dose is used, what are the delivery characteristics, how consistent is delivery with the device, do the characteristics differ according to the different populations, does age/BMI make any difference, are there any serious/suspected adverse events from other similar products that have been excluded here? Plenty of questions will need to be covered.
In normal times, this would take years to answer. In COVID times, these, as well as many other questions are being answered or addressed in weeks/months. Frankly, I'm just impressed they are where they are.
I suspect they are not far off gkb47, bringing any drug to market is a long and arduous process (as it should be!), what I've seen with some of the drug and device development to tackle COVID is just startling, the timelines are just unheard of. However, none of the bodies will compromise on public health and safety and so if these negotiations take a little longer, so be it, you end up with a better result overall. Remember, we are talking about safety data collected in these Phase II studies in hundreds of patients over a couple of weeks in a well controlled patient population conducted to GCP standards and in the real world/emergency use setting, none of those controls are there for the many tens/hundreds of thousands of patients exposed. They will all want to get this right.
Thanks Matml, and agreed Kaeren, it really is a boost for COPD patients, can't wait until they put it back into development for COPD.
Things are really shaping up well.
Today's RNS was significant for a number of reasons, the value of which is not reflected in the current SP.
1) The safety profile in COPD patients is consistent with that seen in the COVID study meaning that no new surprises and along with the safety data collected in the COVID and asthma studies can be used to support an emergency use application/compassionate use/contingent licence. The drug appears to be safe and tolerable for short term use in the manner intended for use.
2) The efficacy results are indicative of supporting exacerbation reduction/lung function improvement in COPD patients. This trial was aimed at GOLD 3/4 patients, who are typically experiencing at least 1-3 exacerbations a year. If up to 60% of these exacerbations have a viral origin and currently there are very few clear treatment options then having an agent that potentially can treat those exacerbations safely will be a big win for patients and healthcare resource use.
Remember, this Phase II study was stopped early and MHRA permission obtained to conduct an interim analysis. The key message here is don't expect the world from any Phase II study, especially not one that's stopped early, for reasons out of their control and look at the data for what it is. It's great safety data and positive efficacy data.
This now supports a filing with regulatory agencies for potential EUA/compassionate use/EAMS etc. Whilst at the same time finalising a protocol for a well designed Phase III study in COVID-19 patients to enable full registration. If the Phase III study is done in the territories where COVID incidence is high, then the study could even be complete by the end of the winter season.
Overall, this is a great RNS, it really supports the strategy of enabling broad and early use of SNG-001 for COVID patients whilst reflecting on the best way to support a COPD registration plan. For anyone who has been involved in COPD studies, you'll know these are difficult to design and execute.
Yes, not all questions are answered yet like overall efficacy profile in either COVID or COPD patients, but there is sufficient efficacy and safety data now to potentially support contingent licence/use authorisation alongside a Phase III study. Getting the right partners on board to execute the plans will be key to moving things forward and it looks like the SYN team are on it. I have great faith the SP will rise a lot more once these sellers are out of the way. Plenty more to come to realise the full potential of what Synairgen have here. DYOR, GLA
CO, it’s not bad news for vaccines. It’s a hypothesis that’s been around for a while. Most of the vaccines have been shown to induce quite a nice cellular as well as humoral response (Pfizer and novavax as examples). The other thinking around the severe form of the disease has been the induction of a cytokine or bradykinin response/storm.
Of course, if the vaccines work, they will prevent progression to any severe form of the disease. Time will tell.
A nice way of seeing it explained. The only way you would be able to tell if a person who tested positive, but is asymptomatic is shedding viral particles rather than active virus i.e. is post acute infection is through combining antigen/molecular test with a rapid antibody test. If the rapid antibody test can detect IgM as well as IgG levels, and say the same person tests positive here too, you could be quite confident they are post acute infection and shedding viral particles.
Now, the unanswered question is how long post acute infectious stage, does active virus still exist in the respiratory tract and still potentially pose a problem as a contagion, for asymptomatic individuals, this is a problem, because we wouldn't know when they were infected and therefore what safe period has passed, if any, after their initial infection. Still many challenges left to address.
Thanks for sharing Chiron. Great to see the discussions are still developing at SAGE. Today’s decision on not testing at airports shows there’s still a way to go convincing the govt. Other countries seem to be going faster and further with the different types of tests and settings and so we’ll probably learn from others how we can use LFTs more widely. All positive news.
Thanks Safy for the articles, good to see the field moving in this direction. Also, shows the importance to detect both the IgM antibody, which tends to present earlier than the IgG antibody, which presents later but resides detectable for longer in the body.