Lots of drugs to enter trials soon

Yesterday, I posted about how there was not much new information coming out about celiac drug trials. I’m going to list what I know, where things stand, and updates on what I find.

Drugs currently or recently in clincial trials

Natren B. infantis – Probiotic that seems to help those with untreated and/or undiagnosed celiac disease. First studied in 2014 with a small study of 22 celiac sufferers. Researchers found that intestinal permeability was not affected, gastrointestinal symptoms were reduced, and TTG and DGP seemed to go down in the B. infantis arm of the study. There was another study that ended in 2018, but no results have been provided, yet.\

Zed 1227 – Here is the press release about them starting Phase 2a clinical trials. Here is the link to the European clinical trial information. They enrolled the first patient in June 2018 and hope to have 160 participants in one of four trial arms. They are looking for minimum effective dose for prevention of gluten-induced mucosal changes in subjects with well-controlled celiac disease undergoing gluten challenge. If you live in Europe, this might be a trial to participate in.

Vedolizumab/Entyvio – Study in New Jersey shut down due to lack of participation.

Hu-Mik-B1 – Here is the link for the trial out of the Mayo clinic in Rochester, MN. Here is another link for refractory celiac trial on this one.

AMG 714 – A trial that went down in flames for both refractory celiac and regular celiac disease. Here’s what I wrote about this one a month ago.

IgY Life Sciences – These guys use IgY (think IgG, IgA, IgM) proteins to help enhance the immune system. Not really sure how this works as their web site is a little light on details. In a petri dish, researchers were able prevent the absorption of gliadin (the protien that harms celiac patients). Now, they have FDA approval for a clinical trial. As of February 2019, they have not started the trial.

Viokase/pancrelipase – This study has been going on since May 2015 and is enrolling 14 patients by invitation. This study talks about how the pancreas might be involved in celiac disease. Not sure really where this one is and can’t find much more on it.

KumaMax aka (PVP) – Nothing new on this one. Here is the link to the study. Last time I checked, they were still looking for celiac volunteers in Anaheim, CA. You can read what I’ve already written about this one here. There is also a #kumamax on twitter if interested in following.

Latiglutenase – Nothing new here either. Here are the previous articles I’ve written.

Larazotide Acetate – Phase 3 trial with 66 sites around the country. Doesn’t prevent damage, just helps alleviate symptoms from accidental cross contamination. Here is what I’ve written about this drug.

Budesonide – Budesonide is also known as Entocort for Ulcerative Colitis. Preliminary studies indicate that budesonide can help symptoms of celiac and calm the immune system. This is a corticosteroid but is not systemic. It seems to remain in the gastrointestinal tract. They are looking at budesonide for treatment for celiac disease. Here is the clinical trial link, again in Rochester, MN.

Here are the drugs in pre-clinical trial – I will talk about one or two of these companies for the next few days.

• Kanyos Bio (Ankio/Celigene/BMS)
• Topas – Eli Lily
• Selecta
• JAK 3i
• Teva
• Bioniz BN-2
• Calypso Caly002
• Sitari Glasko Smith Kline
• UCB
• Provid

The bottom line here is that in order for any of these trials to move forward and cures to be created, we have to participate.

I’ve done the math and here is how it breaks down. There are approximately 320 million people in the US. Statistically speaking, approximately 1% have celiac disease or 3.2 million people. Of those, approximately 50% are diagnosed, leaving about 1.5 million with celiac that have the potential to be in a clinical trial.

Some people will be too young and some will be too old to participate. For some, the trial sites will be too far away to realistically participate. Some won’t be able to provide diagnostic criteria, like blood test and biopsy proven celiac. Some will fail the prescreening because their celiac tests are out of range. Some po Some will have other issues preventing them from participating.

Soon, there are going to be a large number of clinical trials for those with celiac disease. Please find one that suits your lifestyle and isn’t exceptionally burdensome and offer to be a participant. A drug cannot be approved if we don’t participate.