Mongersen Shows Promise for Crohn’s Disease

Mongersen Shows Promise for Crohn’s Disease

shutterstock_139166252A new treatment for Crohn’s disease is showing promise in clinical trials. Giuliani, an Italian pharmaceutical company, conducted a phase 2 clinical study of more than 150 adult patients with Crohn’s disease and found that a significant number experienced remission of their inflammatory bowel disease after only 28 days of treatment with Mongersen.

“There was a pretty high remission rate in a short period of time,” commented Dr. Raymond Cross, a gastroenterologist at the University of Maryland Medical Center, who was not involved in the study, in a news release. “That’s pretty impressive.”

Giuliani’s new drug, Mongersen, is unique from other biologic treatments for Crohn’s disease, such as Remicade and Humira, because it is a pill and the others are injections. According to Dr. Cross, mongersen may also be safer than other medications, but “You can’t really assess safety in two weeks,” he said.

Mongersen, which is under contract to Dublin-based Nogra Pharma, is a SMAD7 antisense oligonucleotide. The drug targets SMAD7 proteins in the ileum and colon to increase TGF-β1, which is a immunosuppressive cytokine that can attenuate Crohn’s disease-related inflammation. As an oral medication, mongersen has maximal drug release of the active compound at the site of the inflamed digestive track.

In the study report, “Mongersen, an Oral SMAD7 Antisense Oligonucleotide, and Crohn’s Disease,” which was published in The New England Journal of Medicine, 55% of patients receiving a 40-mg dose of mongersen experienced clinical remission by day 15, and 65% of patients receiving a 160-mg dose experienced remission. Only 10% of patients receiving a placebo treatment experienced remission.

“These findings are exciting,” stated Dr. Cross, “but they are preliminary.” Future studies are needed to establish the optimal dose of mongersen and see if patients experience remission in the long-term, past the secondary endpoint of 28 days.

If mongersen is effective, it may bring relief to the 700,000 Americans living with Crohn’s disease. Although some therapies exist, patients may develop antibodies against the biological drugs, eliminating any therapeutic benefits. According to Dr. Giovanni Monteleone, lead researcher on the study at the University of Rome Tor Vergata, many biological medications can have serious side effects of infection and psoriasis in the skin. Patients taking mongersen experienced minimal adverse events, and those events were related to worsening Crohn’s disease symptoms.

10 comments

  1. Steve says:

    According to Dr. Cross, mongersen may also be safer than other medications, but “You can’t really assess safety in two weeks,” he said.

    Could it also be said this way:

    According to Dr. Cross, mongersen may also be more dangerous than other medications, but “You can’t really assess safety in two weeks,” he said.

    • Kev says:

      Not really – the implication is that there are positive signs giving reason to believe it may be safer, but more testing is required.

  2. Alec says:

    Well, the logic says, if a disease is inflammatory, start taking natural anti-inflammatory approach. Inflammation is a result of acidic, toxic and unbalanced body. Drinking alkaline electrolyzed 9.5 pH water to remove to balance acidity and to detox. To balance the body start taking balanced nutrition. No inflammation means no inflammatory disease. Make sense? For more info how to get the products twttr @KangenAlec

    • Diane says:

      Alec you have a lot of studying to do! Just take a good look at all the Crohn’s and UC forums online and you will see that everyone with these terrible diseases have done and tried every natural approach out there and then some! Please, you make it sound so simple to cure….only thing is there is no cure, that’s why it’s still a disease! I’m not saying that having good nutrition won’t help; sure good nutrition and using anti-inflammatory foods/herbs/etc. can help some symptoms in some people….but it is not a cure! If Crohn’s could be cured by simply changing diet, drinking alkaline water and using good vitamins and herbs….the disease wouldn’t still exist! Seriously do you really think people haven’t tried what you said?? Trust me, I’ve suffered with Crohn’s for over half my lifetime, since I was 20 years old and I have tried EVERY possible diet including the alkaline diet. I have used every anti-inflammatory herb/food. I have tried Chinese herbs, acupuncture, stress management, yoga, massage. I continue to use the things that help, for example I make my own suppositories out of coconut oil and anti-inflammatory herbs like tumeric. I use bee propolis for ulcer healing. Trust me, people like me who have this terrible disease will try ANYTHING to get better! You sound very condescending and ignorant to say “no inflammation means no inflammatory disease”. It is MUCH more complicated than that and you obviously don’t have the first clue about what actually is causing the disease process for these people, so please do us a favor and keep your dumb remarks to yourself!

      • Marge says:

        Alec, I must agree with Diane. This is a complex disease, it is not IBS, it is not just a flora imbalance, it is not just “flush your system”. I’ve had this for 45 years and I too have tried alternative medicine with traditional medicine. I forgot what good health felt like until my most recent medication. Wow I wish I could eat raw food! We want to be well!!! IT IS NOT THAT SIMPLE. Marge

    • loulo says:

      Hi there…have you used this to treat yourself and had positive results. I agree with the theory but have you used it and had remission. My eldest son has been v ill for 4 years now and we need some guidance. Thank L

  3. Pat Crohnie says:

    The results are based on Crohn’s Disease Activity Index (CDAI) and NOT C-reactive protein (CRP). The drug did not significantly improve CRP in patients w/ elevated (>3mg/L) at baseline. There is a massive disparity betweeen CRP and CDAI response levels in this study…I mean im hopeful for it (i’ve burned through all the anti-TNFs) but Im not thrilled by these results at all

    • Maureen Browning says:

      My daughter is 16 she has been hospitalized 2 times past 9 months blood transfusions TPN has tried every treatment and now Remicade. Still not in remission. She has never had positive inflammatory markers. CRP sed rate etc has always been normal. I’m not convinced that the CPR should matter when evaluating the efficacy of Mongerson. My daughter would benefit from this promising new drug.

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