Here are some research updates. Let me know if I missed one or if I need to do a deeper dive on any of them.
According to ClinicalTrials.gov, the phase 2 Latiglutenase (ALV0003 or IMGX003) trial is complete. Results have not been published. The study completion date was January 22, 2021. This drug is controversial because it had bad results then good results. Hopefully, these Phase 2 results will clarify whether this drug will move to Phase 3 or whether we will add it to the pile of failed celiac drugs to date.
I just found this information on the ClinicalTrials.gov web site. They posted in August 2020 regarding a Phase 1 celiac trial taking place at Stanford. However, Protagonist Theraputics does not list a PTG-100 on their website. Nor is celiac disease mentioned anywhere on their website. However, I will say that from reading about their other drugs, they are talking about counteracting Interleukin-23 (IL-23). IL-23 is an inflammatory part of the immune system acting in skin, intestines, and lungs and plays a significant role in autoimmunity. I’m trying to get more information. Because it is an academic study, we might not be able get more yet.
Gluten Challenge Study
This study in Boston is for a gluten challenge and for our toughest friends – those with silent celiac. Study participants will receive 4g of gluten twice per day for 13 days to determine details of the immune response to gluten. There will a biopsy on day 14 as well, again, to assess the immune response. This study will require some special, sturdy folks to engage.
Cour TIMP-GLIA (CNP-101, TAK101)
The Cour drug is about to enter Phase 2 trials estimated to start in April 2021. They will have 2 experimental cohort groups and within each cohort groups there will be different criteria they are testing for. All groups will have exposure to 3g gluten challenges. It also looks like they are testing the amount of drug required as there are 1g, 2g, and 4g dosing IV regiments. This is probably the most complex study I’ve seen out there, so we will have to see how this one goes. They aren’t supposed to start until April 2021, so I’m sure we will see more between now and then.
This is a Phase 1 study. I’ve talked to them about this study and have been considering entering. This one induces tolerance to gluten via the liver. Also, even though there are a relatively small number of participants required, the pandemic caused them to delay recruiting. Specifically the CEO Kontos explained that the liver-targeting platform technology he developed “delivers proteins into an immune tolerance pathway located in the liver. In doing so, [it] leverages a natural process the liver routinely performs. By using our platform, we retrain the immune pathway to induce tolerance to almost any protein of interest, in this case gliadin (gluten).”