GSK's Crohn's disease treatment fails in Phase III trial

[nogutsnoglory]

"LONDON (Reuters) - British pharmaceutical group GlaxoSmithKline Plc said vercirnon, a drug it was developing to treat Crohn's disease and licensed from ChemoCentryx, had failed in a late-stage clinical trial.

The medicine, which GSK licensed from the California-based company in 2010, did not improve the incidence of adverse events in patients when measured against a placebo, GSK said on Friday, and there was a trend for overall adverse events to increase as dosage levels increased.

The trial failure wiped as much as $242 million, or nearly half, from ChemoCentryx's value. Its shares were trading down 36 percent at $7.47 at 1438 GMT. GSK's shares were up 0.3 percent at 1,672 pence, underperforming a 0.7 percent stronger FTSE 100 index.

"The results from the SHIELD-1 study are clearly disappointing but we are committed to further explore the data to determine the way forward to help patients with this chronic debilitating gastrointestinal disease," said Paul-Peter Tak, senior vice president of GSK's immuno-inflammation research and development.

The company said new recruitment and dosing in the ongoing clinical trial had been suspended pending further review of the results.

Vercirnon, a type of drug called an antagonist, was being developed by GSK for the potential treatment of inflammatory bowel diseases, such Crohn's disease, a condition with symptoms such as persistent diarrhea and abdominal pain."

http://reuters.com/article/idUSBRE97M0NY20130823?irpc=932

 

[Kev]

Another eye opener post, NGNG... OK, I'm surprised that one failure could result in stock drops that radical... but obviously it did (unless there was more to it going on in the background).. I tended to use black/white thinking when it came to big pharma. That no one in the industry pursued LDN for example, because there was no huge profit potential. I guess, as in everything else, there are shades of gray... and taking chances on experimental new treatments can cost even outfits with as deep a pocket as theirs.

 

[nogutsnoglory]

I'm just surprised something went all the way to phase 3 and was pretty much expected to be approved failed this late in the game.

LDN will never be studied because of its inability to be patented. Drug companies could care less, so it will take a cohesive group of patient advocates with a lot of money and connections or government or university research. Unfortunately I think it will take major pressure from activists before we see the government taking it more seriously.

 

[Kev]

Yeah, I agree that the remarkable thing was it went as far as Phase III trials... then failed miserably. Which makes me wonder... if it 'reportedly' didn't fail in initial trials, who ran those... and how on earth were they able to obtain favourable results. Or was this drug 'fast-tracked'??? There have been some significant recalls of patent drugs of late... and some serious fallout... not to overlook class action lawsuits. Scary stuff.

I haven't given up hoping that LDN will go thru similar trials, and pass with flying colors. I think there might be some... oh, poetic justice.. if a communal group of researchers hit it big with that drug. If it has the positive effects on so many illnesses some folks claim, it could become the most commonly prescribed drug ever invented. I'm not holding my breath...just holding out hope... I'm glad this one didn't get off the ground, its another of those names I just can't get my tongue around. Who comes up with these? Sheesh!

The sad, ludicrous, part of all this... all that research, all the money, time, effort spent...on yet another .. "potential" treatment.. all of it for nothing... and a 'real' one like LDN exists... and it is kept out of sight, passed off as a hoax, or worse.. Why????

When I think of the people it could help.. if only they could get their hands on it, or if they weren't 'scared' .. or 'bullied' away from it by doctors (regardless of their reasons)..
No, seriously... when I think of the suffering... the needless suffering.. I get very sad.

 

[rollinstone]

yeah, how the f did it get to phase III and then trump so hard..? this is sad news man, to think all those wasted millions coulda been spent on further research trying to restore the intestinal micro biota as opposed to just throwing a Band-Aid on the wound. Its friggin depressing.

 

[kiny]

All biologics except for infliximab and it's derivatives have failed for crohn's disease.

Because patents of infliximab are running out, a lot of companies are claiming their new biologic is effective when it's no better than a placebo. At least there is new research now because the patents are finally coming to an end.

I would be extremely careful when any company says their new biologic is effective and read multiple studies and opinions. There is tremendous pressure for companies to come out with something new now that the patents are expiring.

 

[rollinstone]

hopefully more effective biologics actually come out soon

 

[nogutsnoglory]

Those damn patents are so long. It makes me sick that suddenly the patent is expiring that they are finding new treatments. Big pharma cares about one thing and its green. I hope that this brings us a few new options. We need a plethora of options.

 

[kiny]

Those damn patents are so long. It makes me sick that suddenly the patent is expiring that they are finding new treatments. Big pharma cares about one thing and its green. I hope that this brings us a few new options. We need a plethora of options.

Patents expirations should be shortened for crohn's disease.

Patents are forcibly removed on certain antibiotics to bring the price down, increase competition and to make them available to 3rd world nations.

I have written many letters to governments to stop using 10 year patents on medication for crohn's disease and to bring them down to 5 years or less.

While companies do need to recoup the cost of their research, biologics have made exponentially more than the research cost them, it was even sponsored by organisations like Crohn's and collitis America.

10 year patents are not helping research, it is stopping progress.

 

[nogutsnoglory]

CCFA has a U.S. legislative action on drugs like biologics. Ill find and post it.