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Celgene drug a first of it's kind for Crohn's disease that could replace infusions

Kathleen Blanchard's picture
A new way to treat Crohn's disease with oral medication in the pipeline

A new drug is in the pipeline for Crohn's disease treatment that is expected to move to a third clinical trial in the near future. The drug, known as GED-0301 or Mongersen is an antisense medication taken orally that has been well tolerated and induced remission in sixty-five percent of Crohn's disease patients studied. The medication could replace injections for treating IBD.


The drug manufacturer Celgene (CELG) has released results of an experimental Crohn's disease drug, GED-0301 that could eliminate the need for injections currently used for IBD treatment,

IBD drug leads to high remission rates

Celgene reported the drug, also known as Mongersen, induced remission of Crohn's disease at two-weeks in sixty-five percent of patients studied compared to just 9.5 percent for placebo, which is higher than rates seen with the injectable drugs Remicade or Humira.

The results were presented at Gastroenterology week in Vienna this week and released by the drug company.Celgene will begin a phase-3 trial of the Crohn's disease drug this year.

Mongersen is known as an antisense drug. Researchers have discovered blocking certain proteins in the body could change the genome that drives Crohn's and possibly a variety of other diseases.

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Studies of antisense drugs for Crohn's disease show that high levels of a compound known as Smad7 interfere with the immune-suppressive activity of transforming growth factor (TGF)-β1. The result is inflammation.

Crohn's and UC treatment is aimed at quelling inflammation that in turn helps prevent complications that can lead to surgeries and repeated hospitalizations.

In the phase one trial, researchers tested levels of circulating cytokines that measure inflammation. Mongersen reduced the number of cytokine expressing cells.The drug was also well tolerated.

"GED-0301, a first-in-class oral antisense therapy, has the potential to change the treatment landscape for Crohn's disease," said Scott Smith, President, Celgene Inflammation and Immunology in a press release."Celgene is excited to pursue the clinical development program for this novel therapy in phase III trials in the near future."

The need for new therapies for Crohn's disease is highlighted by failure of anti-TNF agents that often fail to induce remission of IBD. Celgene's drug GED-0301 or Morgensen is the first of it's kind.

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Although this drug sounds very promising, it always pains me that a real CURE cannot be found from NATURAL sources. I think to myself...yet ANOTHER drug...ugh. All of the medications used to treat UC and Crohn's so far have had either systemic or long term side effects and don't seem to work for very long.
i think crohn is different than colitis.i wonder if MORGUENSENcould cure both. my son ESTEBAN has 3 years with colitis ulcerative, and we dont know what to do with it he is 23 yeras old and is permanently in bed.please let me know if this drug can help him.tks
Hi Jose. I think that is something to discuss with his doctor. Also, the medication is still undergoing trial. Bev, I understand, I really do. A cure would be the ultimate, but of course, until then, controlling symptoms is the only possibility. Thank you both for your comments.
Hi, my partner diagnosed with severe UC just 8 days ago after visit to emergency hospital services. After several days of steroid treatment, last night had first course of infliximab. We're told that 24 hrs will tell if this will be effective or will be discontinued. Next recommended step is virtually immediate surgery. He is 48, otherwise very fit. Is there a trial which fits his state and enables him to avoid surgery at this point?
Would this trial be something safe for someone in child bearing years? We are undecided on having a 3rd child so my options for treatment have been limited by this. I was just invited to participate in this trial in Seattle and am trying to find information on its effect on pregnancy and breast feeding ( I am currently nursing a 8 month old)