OT: Potentially Good news for a therapeutic

Submitted by WesternWolverine96 on April 16th, 2020 at 5:49 PM

This could help. We need some good news.  I want to believe.

 

https://www.statnews.com/2020/04/16/early-peek-at-data-on-gilead-coronavirus-drug-suggests-patients-are-responding-to-treatment/?mod=article_inline

 

"A Chicago hospital treating severe Covid-19 patients with Gilead Sciences’ antiviral medicine remdesivir in a closely watched clinical trial is seeing rapid recoveries in fever and respiratory symptoms, with nearly all patients discharged in less than a week, STAT has learned."

 

The Mad Hatter

April 16th, 2020 at 6:23 PM ^

Good thing the FDA granted Gillead exclusive rights to the drug as a "rare disease" treatment.

Because Covid-19 is so fucking rare.

Can't wait to see how much they'll charge per dose.

L'Carpetron Do…

April 16th, 2020 at 6:40 PM ^

For real - it was rare 2 months ago - not anymore. 

If I recall correctly, the "orphan disease" designation is an incredible boon to these companies and it's often abused by the pharmaceutical industry for tax breaks and exclusivity rights. Also IIRC, Gilead isn't exactly generous when it comes to pricing their prescription drugs. Giving them exclusive rights seems like a bad idea. If they charge a fair price, great, but I got my fingers crossed. (also Feurstein had a mixed rep back in the day).

M Go Cue

April 16th, 2020 at 7:15 PM ^

While there are plenty of abuses, there are a lot of benefits to the Orphan Drug program too.  Most pharma companies wouldnt spend hundreds of millions of dollars developing a drug that only treats rare diseases.  That is unless they have some assurances that they will see some returns on their investment.

awill76

April 17th, 2020 at 3:31 AM ^

Good article link but the article is from March 5th which is ancient in terms of how fast this Covid story is unfolding, and that estimate of cost is just one market analyst group's best guess.  Exact wording as follows:  

"Analysts at RBC Capital Markets expect Gilead would price the drug at around $900 to $1,000 or lower per course, a cost above oral flu drugs but below new intravenous antibiotics." 

The drug itself is reportedly CHEAP TO MAKE, as I've noted many times on this thread, so the main cost would come in the hospitalization and delivery of the drug.  Thus a 5 day course or less would be much less expensive than a full 10 day course (the studies will help to determine which course of treatment is best for how advanced a given infection has gone, of course).  

And finally, ***IF*** the drug does indeed prove to be highly effective against CV-19 then I'd think, perhaps mistakenly, that it would be bought & sold in a *novel* way to ensure the widest, fastest possible worldwide distribution to ensure that the virus is stopped as quickly as possible, saving the most possible lives in the process.  Or maybe I'm just being altruistically naive, but I think that it could not possibly just be 'business as usual' when it comes to something as critical as ending the plague that CV-19 has unleashed on the world these past months.  

Of course we have to see if it's really as good as it seems first.  

Sopwith

April 16th, 2020 at 7:32 PM ^

This treatment was probably the betting favorite from the beginning, and it's also going to end up being the best studied. There are clinical trials underway all over the world. It largely failed in Phase III Ebola trials after promising Phase II, but initial tests in MERS and SARS again showed why it was an obvious candidate. 

At the end of the day, you'll probably see a gold standard treatment involve a small-molecule drug like Remdesivir coupled with a large molecule monoclonal antibody against the viral spike protein, but large molecule therapies are so astronomically expensive it would be far better if this one falls squarely in the realm of good enough.

awill76

April 17th, 2020 at 1:44 AM ^

Yes, exactly right!  Let's hope the results continue to roll in positively.  The drug has already proved to be safe in humans and is ready to go once identified as most effective against COVID-19.  I'm more optimistic about this than any other path forward in antiviral therapeutics and this Chicago U. study though still limited in numbers seems to offer a lot of hope.  

Harball sized HAIL

April 16th, 2020 at 7:33 PM ^

Yeah with 10's of thousands of scientists around the globe working on combating this there is no way a vaccine takes 18 months to be discovered and distributed.  But it will be months at the least.  

Harball sized HAIL

April 16th, 2020 at 8:14 PM ^

Yeah I get that I am just some dumbfuk who has no idea what I'm talking about.

Other than that I have over a dozen customers who all run research facilities in the most bio-tech area of the country.  Clinical trials take 60-90 days.  Then data process.  Then development.  All that will be hyper streamlined but will still take 4 to 5 months if it started TODAY.  Which isn't happening.  Any of it as of now.  

blue in dc

April 16th, 2020 at 8:24 PM ^

‘A Phase 1 clinical trial evaluating an investigational vaccine designed to protect against coronavirus disease 2019 (COVID-19) has begun at Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is funding the trial. KPWHRI is part of NIAID’s Infectious Diseases Clinical Research Consortium. The open-label trial will enroll 45 healthy adult volunteers ages 18 to 55 years over approximately 6 weeks. The first participant received the investigational vaccine today.”  Today was March 16

https://www.nih.gov/news-events/news-releases/nih-clinical-trial-investigational-vaccine-covid-19-begins

BoFan

April 16th, 2020 at 9:14 PM ^

The technology used in the Kaiser Washington trial is novel and hansnt had success in the past.  Let’s hope it works this time because that could shorten the 12-18 month vaccine timeline.  But at this point the vaccine timeline hasn't changed    I do expect treatments and antivirals to be available at some level in 6 months. Those can improve mortality rates.  

1WhoStayed

April 16th, 2020 at 8:48 PM ^

"Yeah I get that I am just some dumbfuk who has no idea what I'm talking about."

Your words, not ours!

Fauci spoke a while ago about streamlining the approach by bankrolling companies to expedite development without certainty that a vaccine will work. That has been a historical blocker. Also, he mentions that they would enter subsequent phases earlier than normal. 

And you are wrong about it taking 4-5 months. It will take longer under the most expedited scenario. And it is happening today.

There are a lot of good things happening. It's a shame the POTUS doesn't get out of the way and let the COVID Task Board articulate them!

blue in dc

April 16th, 2020 at 7:50 PM ^

I think most of the time is spent on testing to prove it is safe, not on development.  I believe they have to start with small scale trials just to prove it is safe before even worrying about it being effective as a vaccine.  Then you can move on to larger trials before finally moving on to manufacture and use.   There is only so much that can be done.    Ironically if effective treatments are found, it could slow down the vaccine process because there would be less impetus to allow corner cutting.   If treatments lowered the mortality rate and time people were in the hospital, there would be less of a driver.

awill76

April 17th, 2020 at 1:49 AM ^

That's correct unless people want to volunteer themselves as human guinea pigs for an incompletely tested vaccine.  Frankly a lot of people might want to do just that and I can't blame them.  Esp. the elderly who might figure it's better to get some likely protection sooner than the longer bet with more certainty but perhaps not in time.  

BoFan

April 16th, 2020 at 9:10 PM ^

Harball, you are confusing the time it takes to develop and test a vaccine vs an antiviral.  The OP is about an antiviral which is much faster.  Vaccines are still realistically 12-18 months. There is one rna vaccine that started trials in Seattle but that technology has not worked yet in the past so put a lower probability on that succeeding.  The OPs antiviral reference is one that has a higher probability of working.  So that is good news.