Two new studies have just started – TAK-062 and TAK-101. Today is TAK-062 or the old PVP Biologics drug.
A little history first, PVP Biologics created a gluten degrading enzyme. At the end of their very successful Phase 1 clinical trial in 2020, Takeda purchased the drug from PVP Biologics. Takeda is a large international drug manufacturer with a strong presence in the gastrointestinal diseases marketplace. In other words, Takeda is not new to drugs for gastrointestinal diseases.
TAK-062 is a gluten degrading enzyme. Takeda did a study at Stanford in 2021 where they gave patients doses of TAK-062 and gluten. Then they pumped the patient’s stomachs to see if the TAK-062 was able to break down the gluten. That test was successful and here are the results. https://pubmed.ncbi.nlm.nih.gov/33741317/
Now, TAK-062 is entering Phase 2 trials with 350 participants and have begun recruiting. The only location recruiting right now is in California, but they are supposed to be opening many locations across the US and UK. This information was just updated in the ClinicalTrials website at the end of last week, so there will be more locations opening soon, I hope.
For the study, it will be 36 weeks long with several different arms. But the gist of it is, the patient will take a TAK-062 or placebo with each meal. The participant will also take a “Simulated Inadvertent Gluten Exposure” bar or placebo. There are also endoscopies involved, but it is unclear how many and when.
Note that most celiac patients are exposed to gluten on a regular basis and studies have shown that clinical trial participants clean up their diet so much that it can throw off the results of clinical trials. This bar attempts to provide minimal gluten exposure but enough to simulate normal gluten exposure in the real world overcoming the diet clean up automatically done by patients in clinical trials. If you are concerned about this gluten exposure, during the screening process, they will check to see if you have a severe reaction to the bar.
This is a high level overview as more information comes out, I’ll let you know.
Here is the clinical trials link – https://clinicaltrials.gov/ct2/show/NCT04530123
Here is Takeda’s web site about the trial. https://clinicaltrials.takeda.com/study-detail/44e4ec7deb684f49?idFilter=%5B%22TAK-062-2001%22%5D