Today is TAK-101…
Cour Pharmaceuticals developed a nano-particle encapsulating gliadin molecules. Gliadin is one of the proteins in gluten and the one that causes issues in celiac disease. In Phase 2 studies, they gave patients infusions of the drug or placebo and then a 14 day gluten challenge. Patients that got placebo had obvious effects. Patients that got the drug did not. Takeda acquired the Cour drug and have started recruiting for their new clinical trial.
This trial lasts approximately 24 weeks, but is different than many of the other trials I’ve seen. Patients will receive drug or placebo via IV infusion on Day 1 and Day 8. Then there is a 6 day gluten challenge, followed by several single day gluten challenges. ALL patients will receive the drug at week 24. ALL PATIENTS WILL RECEIVE DRUG AT WEEK 24.
This means that if the drug works and you participate in the trial, whether in the drug or placebo arm, you are guaranteed the drug. That is HUGE because the downside to getting placebo is massive. But if the drug works, that is a MAJOR benefit to participating and there is no risk. When I say “no” risk, there are obviously risks to participating in a clinical trial.
For everyone that was excited as I was about this Cour drug, this is your opportunity to participate. Also, as more comes out, I will keep you in the loop.
Here is a link to the clinicaltrials information. https://clinicaltrials.gov/ct2/show/NCT04530123