Injection #5 went in yesterday. There were some pretty harsh gastrointestinal side effects. I had to come home early from a Super Bowl party because of them. 🙁 I also didn’t have any Tito’s yesterday and lost my tennis match (6-2,2-6, 5-7). I guess you could say it was a rough day.
But I don’t really look at it that way – I see it as, I was healthy enough to participate in a 2+ hour long tennis match. I got to hang out with my friends for the first half and my family for the second half of the Super Bowl. Also, I’m lucky enough to be able to do this drug trial hoping that I won’t have to endure the gastrointestinal distress much longer. So, there’s your half full for the day.
I know you all are interested in the drug trials. There have been two trials that have been in my consciousness for a while – Nexvaxx (which I’m doing) and Larazotide Acetate (INN-202).
Larazotide Acetate is entering Phase 3 FDA trials in mid-2019. The trial will accept almost 1,000 patients. Phase 2 trial data is out for this medication and the reviews are mixed.
Larazotide Acetate is a synthetic eight amino acid peptide that keeps the tight junctions in your small intestine closed. If you know anything about leaky gut, this will help with leaky gut. If you solve leaky gut, then you potentially solve celiac disease. The big question is – is leaky gut the cause or result of celiac disease? I don’t know that we know the answer to that question. But if you stop the leaks does the celiac stop?
Phase 2 trial data indicates that this drug might be effective at keeping the gastrointestinal symptoms, fatigue, and headache at bay during normal life.
It is my understanding that this is how the study was done. Again, I’m not a scientist, but this is how I’m reading the results.
They found people with confirmed celiac diagnosis. They confirmed their blood work was now in the “normal” ranges to confirm GFD compliance. Then did a 4 week “run up”, 12 week trial, and 4 week “run off”. They compared the “run up” and “run off” times to the 12 week trial week in terms of symptomatic days and non-symptomatic days.
They found a significant reduction in symptomatic days for people who took the drug vs. placebo – good sign. They did not show an increase in anti-tTg antibodies during gluten challenge – again a good sign.
This is great – it shows their drug alleviates symptoms in a real day to day setting.
There is more to this study, but we will talk tomorrow about the limitations of the study and what it doesn’t prove like lack of study participants over 65, lack of histology (endoscopic biopsies), and specificity to celiac disease.