Phase 3 Clinical Trial

Yes, that’s right. There is a Phase 3 Clinical Trial starting soon for the drug Larazotide Acetate or INN-202 by Innovate Biopharmaceuticals.

I’ve been looking for this Phase 3 clinical trial and have been waiting with bated breath for it. It was supposed to start in May 2019 and hasn’t started yet. The link on the government website for clinical trials hasn’t been updated to reflect the locations this study will be taking place. The start date hasn’t been updated either.

They are looking for 630 participants that have blood test and biopsy confirmed celiac disease diagnosed at least 6 months ago, have been gluten free diet for longer than 6 months, have ongoing symptoms, and are willing to maintain their gluten free diet. There is no age limit listed. The only exclusionary criteria listed are refractory celiac and other active gastrointestinal disease – probably crohn’s or colitis. Pretty easy criteria to get into the study.

Looks like the study lasts for 12 weeks and there are three study arms– Larazotide 0.25mg capsules, Larazotide 0.50 mg capsules, or placebo. The outcome they are looking for is a reduction in self reported symptoms on the CeD PRO Abdominal Domain┬áScores. When I did Nexvax, I took this evaluation daily. It took less than 5 minutes to report my symptoms on 12-15 (if I remember correctly) question survey.

They don’t have the locations of the study or the exact start date listed in either the press release or the clinical trial government web page.

I do have some concerns about this drug and how it works. I’ve written other blog posts about this drug specifically. Here is the first post and the second. I still think this might just mask symptoms and that’s okay. Maybe if we have an accidental glutening and don’t experience symptoms, that’s okay. I’m not sure its a cure though. So, I’m still on the fence about this one.

Anyway, the bottom line is that drugs are making progress and we might have something sooner rather than later.

PS – I’ll get back to the genetics tomorrow.

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