TIMP-GLI is another drug in the Celiac development pipeline. They are trying to “envelop” the gluten particle and deliver it to parts of the body that can dispose of it without causing damage.
This drug is currently in Phase 1 trials after successful animal trials.
In 2015, Cour Pharmaceuticals announces pre-clinical animal study results at the International Celiac Disease Symposium. Who the heck knew there was an International Celiac Disease Symposium? Just in case you want to go it is September 5-7, 2019 in Paris and you might be able to get 500 Euros to help you attend.
It seems they put an animal with Celiac Disease on an IV drip of their nanoparticles. Then they fed the animal gluten. Their animal study results indicate the animals maintained normal body weight, duodenal biopsies were improved, lower inflammatory markers, and the treated animals were better off than those that maintained the gluten free diet alone. The best words out of that are duodenal biopsies improved and lower inflammatory markers.
In the 2015 press release, they describe how the drug works, “Toleragenic Immune Modifying nanoParticles (TIMP) consisting of a safe proprietary polymer and antigenic proteins (gliadins). The antigens are fully encapsulated for safety and dosing is administered intravenously. Once processed, the TIMPs control and regulate the auto-reactive T-cells, the primary driver of [Celiac] disease.” Sounds great! This seems like an auto-immune modulator, but I can’t tell for sure.
The Phase 1 trials are not currently recruiting but are active and ongoing. In other words, they have all of their volunteers and still have active patients in the study.
Again, not much out there because there haven’t been many human trials. I’m hoping this changes in the next 6 months with this company. This drug is another exciting option.
In talking with my sister that has a Celiac daughter and invests in biotechnology companies, there are two parts in getting a drug to market. The ability to get through the gauntlet of FDA approval and the financing to support the studies and marketing. I’ve run across one company, Takeda, that has their hands in 2 drugs. This one TIMP-GLI and PvP Biologics (AMG-714, we talked about this earlier). It seems Takeda has the deep pockets here making these two drugs more likely to get through? I don’t know. TMP-GLI is Phase 1 and AMG-714 is mid-Phase 2. But I do find it interesting that these are the two drugs they’ve invested in. Maybe, I need to buy some stock!
Tomorrow – I’m going to write about the expectations of my last trip to Nashville.