Promising New Treatment for Ulcerative Colitis

An investigational drug with the code name AJM300, an orally active, small molecule α4 integrin antagonist, has been shown to inhibit the binding of α4β1/α4β7 integrin-expressing cells to VCAM-1/MAdCAM-1, and has been evaluated in patients with moderately active ulcerative colitis.

This approach was discussed at Digestive Disease Week 2014 in Chicago, IL, during a joint presidential plenary session moderated by Kenneth Wang, MD, president of the American Society for Gastrointestinal Endoscopy, and Anil K. Rustgi, MD, president of the American Gastroenterological Association Institute. The session highlighted some of the most innovative current research in gastroenterology and GI endoscopy.

Mamoru Watanabe, MD, PhD, from the Tokyo Medical and Dental University, presented the AJM300 results. He said, “The proportion of patients achieving greater response was significantly higher in the treatment group than in the placebo group. In addition, a higher proportion of patients with clinical remission… and histological improvement were also observed in the AJM300 group.”

Researchers evaluated the efficacy and safety of AJM300 in 102 Japanese patients with ulcerative colitis. The patients had:
A Mayo Clinic score from 6 to 10
An endoscopic subscore ≥2
A rectal bleeding subscore ≥1
An inadequate response or intolerance to 5-ASA or corticoids

In this double-blind, multicenter, placebo-controlled phase 2a study patients were randomly assigned to receive 960 mg of AJM300 or placebo three times a day for 8 weeks.

The primary goal was to reduce the Mayo Clinic score by at least three points and achieve a 30% decrease from baseline by week eight, and to decrease the rectal bleeding subscore by at least one point or achieve an absolute rectal bleeding subscore of 0 to 1.

The investigators reported that 62.7% of patients in the AJM300 group achieved those results vs. 25.5% in the placebo group (odds ratio [OR], 5.35; 95% confidence interval [CI], 2.23 to 12.82; p=0.0002).

Nearly one in four participants in the AJM300 arm (23.5%) also achieved the secondary endpoint of clinical remission at 8 weeks, compared to only 3.9% of the placebo group (OR, 7.81; 95% CI, 1.64 to 37.24; P=0.0099).

Mucosal healing was better in the AJM300 group at week 8 than in the placebo group‑‑58.8% vs. 29.4% (OR, 4.65; 95% CI, 1.81 to 11.90; P=0.0014).

Results were achieved without serious adverse effects or infection. The investigators said these findings indicate that this therapy may give patients alternatives to biologics in improving quality of life.

“AJM300 may be of benefit to patients with IBD (inflammatory bowel disease) as a novel oral therapeutic option,” said Watanabe.

Oral drug formulations may also solve some of the problems associated with biologics, including their substantial cost, he said.

I always find it amazing how high the scores are for placebos in all of these various studies. You'd think that with UC being a real physical disease that the placebo group would never fare as well percentage wise and yet they often have respectable numbers.

So, for a 23.5% remission rate, this drug will probably cost $2K per month. The overall effectiveness of these drugs do not line up with the prices they charge. I'd love to see something with a 75% remission rate someday.

@Indycat23 - Id be shocked if this drug cost anywhere near what Humira cost. One of the reasons Humira and remicade cost so much because of the route of administration. Its much more costly to inject someone with a drug than it is to deliver it orally. On top of that, its only a small molecule, not an antibody, so the cost will again be negligible in comparison

"UC being a real physical disease that the placebo group would never fare as well "

because UC is not real, it's in your head, son.

Marauder93 said...
@Indycat23 - Id be shocked if this drug cost anywhere near what Humira cost. One of the reasons Humira and remicade cost so much because of the route of administration. Its much more costly to inject someone with a drug than it is to deliver it orally. On top of that, its only a small molecule, not an antibody, so the cost will again be negligible in comparison

Unless it is many hours of infusion, the cost of the drug is often greater. Often cost of infusion center is only $500-$600 for a few hours. The drug is often $1000+/vial.

At my local hospital, I pay about $300/hr for the infusion room, and another $80 for the IV placement. The iron infusion I get is $2000/vial.

The cost is not based on molecule size, but rather based on providing return on investment to the large venture capital invested in the development. There is great creativity, but also great exploitation, in for-profit medicine/pharmacy industries.

wow I thought with the Obama-care you were not paying so much for meds, that really sucks...

Here in France we pay almost nothing for meds, and for those who really want to pay nothing we have insurances that cost around 40-50$ per months to handle everything.

But we pay a ton of charges on the other hand, when working as an employer or working for ourselves charges here are huge.

But it's a good system though where everybody can have meds even if ones have no money.

I hope you guys will be able to have the same system one day in your country, because it makes me very sad when I read some of you can't pay for their treatment.

Yeah I know, oligarchy is little by little coming to our doors here too, corruption is also very present here, with all that stuff concerning mass control of populations, lobbies, etc, it smells bad for the future...

Lol our president is wasting his time seducing chicks instead of doing his job, and our new prime minister is a crossing between hitler and pinnochio, so let's see how it will go...

I would have been very happy to send you some cheese from here, but your postman won't appreciate the smell I think!