Larazotide Acetate is the only drug for celiac disease in Phase 3 clinical trials.
Larazotide Acetate has been given fast track designation by the US Food and Drug Administration. Fast track designation means expedited review to facilitate development of drugs which treat a serious or life-threatening condition and fill an unmet medical need. Celiac disease certainly fits that designation.
9Meters, formerly Innovate Biopharmaceuticals and developers of the drug, just put out a press release that the FDA has approved a “thorough QT (TQT) study waiver.” According to the press release, “Phase 1 and Phase 2 studies in healthy subjects and celiac patients that include higher doses than the proposed highest dose currently in clinical development. In those studies, neither larazotide acetate nor its metabolites were detected in human serum using highly sensitive assays.” In other words, larazotide acetate was not absorbed by the body. Drugs not being absorbed by the body is not a bad thing.
Here is the nugget to take away from the press release – the trial’s interim analysis is expected in the second half of 2021. So, we will know a lot more about the drug then. My guess is the results will be glowing. 😉
My take
Also, personally, I’ve never been a big fan of this drug. It seems more like a “leaky gut” drug than something designed for celiac disease. It is a “tight junction” regulator which means it helps to maintain the gut lining and not let foods “leak” outside the gastrointestinal tract. Phase 2 results showed a reduction in symptomatic days and a reduction in symptoms on symptomatic days. Here is what I wrote about the Phase 2 results last year and here.
As we all know, I firmly believe we need something – a shot, a pill, a something to help with celiac and all of the joys that come with it. But it brings up the question – what is the minimum amount of help I would need to observe before taking a drug? What side effects and/or out of pocket costs are we willing to endure for a 25% reduction in symptomatic days? I’m not sure. Maybe it is something to explore.
I’ve always looked at taking a drug for celiac disease as a “cure” rather than a “symptom reducer”. I always looked at it as a way to return to a normal diet rather than something that would stop my symptoms. To be honest, I’m not a terribly symptomatic celiac either. I have diarrhea most days, but it isn’t bothersome. It doesn’t interfere with my days. Or maybe it does. When I ask my kids if I am sick a lot, I receive an emphatic YES! Maybe I do need to re-evaluate how I think about a potential drug. I guess I need to do some soul searching on this topic.
Thanks for reading – FC!