Here’s another drug deep dive into KumaMax provided by PvP Biologics and Takeda Pharmaceuticals.
KumaMax or as it is listed at ClinicalTrials.gov as PvP001 and PvP002. There is an active Phase 1 Clinical trial currently running in Anaheim, CA and Michigan Medicine at the University of Michigan.
This drug is a gluten degrading type drug. It appears this drug works in the stomach to degrade the portion of gluten that causes the immune response in Celiac disease. Because KumaMax (Kuma062) degrades the immune-reactive portion of gluten before leaving the stomach, there should be no damage and no reaction to consuming gluten.
Stopping the damage before it stops is a great option for curing Celiac disease. In reading their website, they talk about “reducing” the effects of gluten and mucosal damage, so they might not think of this as a cure just yet. This is what their press release says regarding the drug, “Preclinical studies have demonstrated that Kuma062 has high enzymatic activity under acidic conditions to break down gluten and has significant potential as an oral treatment.” We will see how this goes.
Since this drug is only in Phase 1 trials, we have a long way to go. right now, they are recruiting for healthy volunteers first. They will give the healthy volunteers the medication and see if there are any Treatment Adverse Events. Adverse Events are can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporarily associated with the use of a drug, without any judgment about causality or relationship to the drug. So, if someone is given the drug and they start to throw up, that is a Treatment Adverse Event.
In this study, they are going to give healthy individuals the drug first. Then, assuming no Adverse Events, they will then give the drug to biopsy and blood tested confirmed Celiac disease sufferers. Participants will also be doing a gluten challenge after receiving the drug to determine percentage of gluten degradation. I’m not sure how they will test for gluten degradation, but I can only assume via stool?
This seems like an interesting idea – stop the damage before it starts. But would this be an ongoing drug or would it be a once or twice deal? I think this is so early in the trial process, I think there is a long way to go on this one. But it is certainly another way to tackle this ungangly Celiac beast.
I wanted to put it out there because we should look at all of the options, not just my favorites. My sister has her favorites and I’m sure each of you have your favorites. As I go through each of these ideas and learn more, I think we might be further away from a cure than I had hoped. However, that doesn’t mean in the next 10 years or so there won’t be something.
I found a graph doing the AMG714 research talking about drug trials, how long they take, and how few drugs actually make it to production. It takes 5,000-10,000 compounds to start to get 5 to clinical trials to get 1 drug approved. Right now, we have about 15 drugs in clinical trials or the start of clinical trials, so our odds are good that something will be along. We even have 1 in Phase 3 clinical trials that start in June 2019, so again, the race is on!
The other thing I saw yesterday is Budesonide has been tested on 12 people for acute gluten exposure. And it helped with gastrointestinal symptom relief not extraintestinal symptoms. So, if you have stomach ache, bloating, or diarrhea when getting glutened, Budesonide may help. If you have a lot of brain fog and body aches, it seemed not to help.