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[dafad] 18/5/2020 07:10

interesting

evespi Aerosphere approved in China for patients with COPD

First approval in China of a fixed-dose, long-acting dual
bronchodilator in a pressurised metered-dose inhaler device​

AstraZeneca's Bevespi Aerosphere (glycopyrronium/formoterol fumarate) has been approved in China as a maintenance treatment to relieve symptoms in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

The approval by the National Medical Products Administration (NMPA) was based on positive results from the Phase III PINNACLE 4 trial1 in which Bevespi Aerosphere demonstrated a statistically significant improvement in lung function as measured by trough forced expiratory volume in one second (FEV1), compared to its monotherapy components and placebo, all administered twice daily via pressurised metered-dose inhaler (pMDI) in patients with moderate to very severe COPD. The trial formed part of the broader PINNACLE clinical trials programme showing efficacy and safety and involving more than 5,000 patients across Asia, Europe and the US.2,3,4

This was the first approval by the NMPA for a maintenance, fixed-dose, long-acting dual bronchodilator combination therapy in a pMDI, which uses the innovative Aerosphere delivery technology.

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: "Chronic obstructive pulmonary disease affects almost 100 million people in China and presents a significant patient and public health burden. The use of maintenance combination therapies in China is increasing year-on-year and the approval of Bevespi Aerosphere offers an important new treatment and choice of inhaler for patients, particularly those with limited lung function and advanced age who may benefit from using a pressurised metered-dose inhaler."

Bevespi Aerosphere is already approved in the US, EU, Japan and other countries for the long-term maintenance treatment of moderate to very severe COPD.

The approval of Bevespi Aerosphere follows the recent approval of AstraZeneca's triple-combination therapy, Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate), for the maintenance treatment of COPD in China.5

COPD
COPD is a progressive disease which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness.6 It affects an estimated 384 million people worldwide and approximately 100 million people in China.7,8 COPD is the third leading cause of death globally.6 Improving lung function, reducing exacerbations and managing daily symptoms such as breathlessness are important treatment goals in the management of COPD.6

PINNACLE
PINNACLE 1, 2 and 4 were randomised, double-blinded, multi-centre, placebo-controlled trials conducted over 24 weeks, which compared the efficacy and safety of Bevespi Aerosphere administered twice daily via a pMDI to its monotherapy components (glycopyrronium and formoterol fumarate) and to placebo.1,2,3 In PINNACLE 1, open-label tiotropium was included as an active control.2 PINNACLE 3 was a multi-centre, randomised, double-blinded, parallel-group, chronic-dosing, active-controlled, 28-week safety extension trial of PINNACLE 1 and 2, which evaluated the long-term safety, tolerability and efficacy of Bevespi Aerosphere administered twice daily via a pMDI compared to its monotherapy components.4 All the trials were conducted in patients with moderate to very severe COPD.1,2,3,4

[nobbygnome] 18/5/2020 06:55

I would go far as to say it is impossible if they do the proper testing. Clearly the MHRA has given them the nod that cutting of corners will be accepted. So I will be very sceptical of taking it if and when it magically appears!

[mostro] 18/5/2020 06:42

So good old Dr Sarah at Oxford is now telling the Government, who are now telling the Daily Express, that the UK will have 30 million doses of vaccine by September..
Great story, but sadly no-one in the medical world ( except Dr Sarah at Oxford )seems to believe it..
Sounds a bit like that old IMMUfarce promise from a couple of years back..

[yet another final] 18/5/2020 00:15

Fair enuf AquillaThere has been a lot of smoke and mirrors in the daily updates, and it pains me to see the experts 'joining in' with the hype, as subtle as it may be.... the likes of CW, JB, PV and JVT are extremely bright and highly respected (premier league as we would say) but are likely to be pressured into creative soundbiting if such a verb exists

[aquilla] 17/5/2020 23:56

Torreskid, I happen to believe SNG has a worthwhile product whether a vaccine comes along early or not, though obviously an early vaccine would affect the take up for SNG001.
Medical opinion? I'm no medical expert but you don't really think the government themselves would come out with that sort of statement unless they had it backed up by some pretty convincing medical opinion. Yes, it is a long shot but still a possibility. To quote Sir John Bell, Regius Professor of Medicine at Oxford University:
"There is one vaccine that looks like it could beat those numbers, and perhaps be available for by the end of September.That's the vaccine developed by my institute in Oxford.I think it's possible that we'll see efficacy data by the summer.
In which case, if we're on our toes, and get regulation approval by August or September, it's possible we could vaccinate the population by the end of September."

[cambradjones] 17/5/2020 23:55

Been a month since we had 2 consecutive up days. Would be nice if we could continue Fridays climb into tomorrow.Catch you all 8 am sharp.Or if we are lucky, 7am !!!

[itshenderz] 17/5/2020 23:04

Good luck all genuine investors, should be an interesting week as dates draw closer.

[dovey21] 17/5/2020 22:47

Any rushed through vaccine will not be going anywhere near me or my family! It is ludicrous to suggest they will or might have a vaccine by September!

[torreskid] 17/5/2020 22:43

aquilla, its called sound bites

and if u believe that, then what are u doing investing in SNG

I gave my medical opinion, so give me the courtesy of a researched answer/remark

[makendon] 17/5/2020 20:37

Dave44, that’s the point we’re making, Amaretto said we were on bbc news this morning, on further research, it was nothing to do with SNG 🤷🏻 - just trying to keep things right.

[1marcr] 17/5/2020 20:19

I would like to think that they would offer it to the most vulnerable first but surely this is a risk in itself.I doubt they've trialled it in vulnerable people.

[dave444] 17/5/2020 20:13

Bradford are not involved in the Synairgen trial -they are involved in the recovery trial - completely different!

[investor114] 17/5/2020 20:09

Dr Dinesh Saralaya is running 4d Pharma(DDDD) Trial.





makendon17 May '20 - 14:02 - 7212 of 7231
0 0 0
>> amaretto1 Re post 7201

So I went back through the news from 7am this morning.... no mention of synairgen or any inhaled therapeutics. The Consultant Dr Dinesh Saralaya was from Bradford and mentioned NIHR and of the numerous urgent trials being carried out across the UK. Interesting, but not relevant

Unless of course you were watching a different BBC news report this morning at 7:30

[dealer55] 17/5/2020 20:03

I’ve not been impressed with Boris young cabinet. Well spoken but lack conviction and clarity. Boris was close to dead and shouldn’t really be at work and had to drop the ball when off. The medical man said everything is on vaccines and that testing is key, then opens beaches then police stop people and then stay home then stay alert. We have done a bit of every strategy but convicted to none. There will be a huge inquiry post this and it’s not over. Come autumn no doubt all the freedom we get will disappear again as we second surge. SNG can support the if someone gets it and dips they won’t die or probably won’t people can return to normal knowing if things go bad they can recover.

[amaretto1] 17/5/2020 19:13

Then it's saying Boris is not confident + far too earlyIt's all ... contradicting each other

[eeza] 17/5/2020 19:02

"In April, AstraZeneca’s chief executive, Pascal Soriot, said scientists could know as early as June or July whether the Oxford vaccine works. Researchers running animal trials reported last week that monkeys who received a single jab produced antibodies to the virus within a month. The vaccine did not completely protect the animals from infection but did appear to prevent them from developing the kind of serious lung damage that has claimed so many human lives.

Stephen Evans, a professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, said: “We do not yet know which if any vaccine will work. It is more than likely that at least one will prove effective and safe. The most important thing is to get the infrastructure in place to vaccinate tens of millions in the population, so it is simply unknown whether opening a vaccine manufacturing facility is the best use of the money.”

Sharma said that “in spite of the tireless efforts of our scientists, it is possible that we may never find a successful coronavirus vaccine,” and that six drugs that might help fight the infection had entered UK clinical trials."

[amaretto1] 17/5/2020 18:58

It's Goverment propaganda Seeing to be doing somethingNo way, I'd put that in my body It won't even get to that stage anyway,Synergen is going to be the clear answer to thisIt's more and more odvious It will be to everyone else as well.

[74tom] 17/5/2020 18:53

Yep, what I don’t get about the Oxford Vaccine timeline is how they plan to measure potential short to medium term side effects of any vaccine if they are only going to leave a few months between creation & administering.

It’s madness to claim half the population could be given a rushed vaccine - what happens if it actually makes people more susceptible to Covid-19 / something else?!

[amaretto1] 17/5/2020 18:46

Not to mention, one hasn't even started yet, till next month.The whole situation is crazy.

[amaretto1] 17/5/2020 18:28

He also said.. they might not even find a vaccine They are trying to put confidence in people ... giving untested hope !!

[aquilla] 17/5/2020 17:49

Torreskid, I hope you were watching Alok Sharma, the Business Secretary, chairing today's Covid 19 briefing.
"The speed at which Oxford University has developed these trials is unprecedented...If current trials are successful we will have 30 million doses available by September."

[makendon] 17/5/2020 17:21

It would be nice of the govt to confirm the 6 names in the accord study. Either by updating their .gov website or disclosing during one of the evening briefing.... they seem to get very close, but then no one asks them who’s in the study.... continue to be annoyed (on behalf of SNG and this BB) by the many missed opportunities

[torreskid] 17/5/2020 16:57

A reliable vaccine may not be ready for years.... you may accelerate the development of a vaccine, but u may 'never' be allowed to cut corners with testing prior to release

Firstly you need to prove a vaccine can generate the right immunological response, and ensure its effect is persistent for tears to come (at least one year). Secondly you need to ensure the unwanted side-effects do not impact the same number that the disease would have (Cure needs to be better than the disease...only thing Trump got right?!)

So until then...we need therapies that reduce severity of disease

[aquilla] 17/5/2020 16:15

From today's Telegraph online:

"On April 23, a potential coronavirus vaccine being developed at the University of Oxford began human trials.
Now a study involving up to 510 healthy volunteers between 18 and 55 is under way in Oxford and Southampton, with three further sites likely to be added."

This might be where the confusion has arisen.

[torreskid] 17/5/2020 15:07

Southampton are doing multiple covid trials (as is most of the country)
SG016 - closed
Recovery - ongoing
?Remcap (not sure if that is the real name) ongoing - looking into treatment in very ill patients (there is an interferon arm but I dont have the specifics...will try and update tomorrow)