TIX100 is a protein which inhibits the action of TIXNP (thioredoxin-interacting protein). It is being developed by the TIXIMED company. TXNIP is elevated in pancreatic islets of people with type-1 diabetes and causes beta cell death and dysfunction. The hope is that inhibiting that protein will protect beta cells and therefore delay or prevent T1D.
Anath Shalev, a researcher at the University of Alabama, Birmingham is leading this research effort, first at UAB and now also at TIXIMED. She first identified TXNIP in 2002 in human islets exposed to high glucose and then later showed that it played a role in glucose toxicity and diabetic beta cell loss. Research has shown that inhibiting TXNIP protects beta cells and promotes beta cell health and function.
Recently she has run clinical trials for Verapamil, which lowers TXNIP and is already approved in the USA for the treatment of high blood pressure, migraines, and heart problems. I have blogged several times on those studies, but especially the results from a phase-II trial here:
I also listed it as a drug to watch in 2024:
because there is another phase-II study ongoing in Europe, but it is now scheduled to finish in 2025 or 2026.
TIX100 is an oral medicine, and a "small molecule", but I have not found any other public information on what it actually is. It has been tested in animals for T1D, T2D, nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH). For example:
https://diabetesjournals.org/diabetes/article/72/Supplement_1/97-OR/150782/97-OR-Antidiabetic-TIX100-Improves-NAFLD-NASH-in
https://diabetesjournals.org/diabetes/article/72/Supplement_1/97-OR/150782/97-OR-Antidiabetic-TIX100-Improves-NAFLD-NASH-in
This Study
This is a blinded dosing study done in healthy people. They are recruiting 35 people, none of whom have T1D, and giving them 6 different doses ranging from none to 200 mg of TIX100. The goal is to make sure all potential doses are safe.
This is a single dose study, follow up is after one week, and they expect to be done by May. Because the end points are all safety and side effect related, we will not know anything about efficiency (if it actually works against T1D), but "the trip of 1000 miles starts with a single step". Good results here will presumably enable an efficiency focused phase-II study.
The good things about this study are that it is quick and easy to participate in. They are recruiting in one location:
Chula Vista, California, United States, 91911
ProSciento, Inc. 619-427-1300 hello@myproscientostudy.com
Corporate Web Page: https://tiximed.com/
Corporate Interview: https://www.youtube.com/watch?v=sezKoZi7lJU
To see a longer history of research into curing type-1 diabetes by targeting TIXNP, you can read this article: https://www.news-medical.net/news/20240731/FDA-clears-UAB-startups-TIX100-for-clinical-trials.aspx
Clinical Trial Registry: https://www.clinicaltrials.gov/study/NCT06800729
Joshua Levy
http://cureresearch4type1diabetes.blogspot.com
publicjoshualevy at gmail dot com
All the views expressed here are those of Joshua Levy, and nothing here is official JDRF or JDCA news, views, policies or opinions. My kid has type-1 diabetes and has participated in clinical trials, which might be discussed here. My blog contains a more complete non-conflict of interest statement. Thanks to everyone who helps with the blog!
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