I’ve had lots of requests about an update on the drug trials. Here’s the KumaMax update.
First, I wanna talk about some overall categories of drugs out there. There are the immune modulators – like Nexvax – that modify the immune system to ignore gluten. Next there are the gluten envelopers. These are the drugs that wrap the gluten molecules in a protective coating that allow the gluten to pass through the system without doing damage. Finally, there are the gluten degraders. These cause the gluten molecule to degrade or break apart in the stomach and then pass through the small intestine safely. These are the three primary methods that are being used in drug research for celiac disease.
Let’s talk about KumaMax. I’ve gotten two recent messages about this one. There is a Phase1 trial for this drug going on in Anaheim, CA. They had a second site at Michigan Medicine in Ann Arbor, MI that was shut down due to removal of funding. So, they might have had trouble recruiting volunteers in Ann Arbor, but didn’t have trouble in Anaheim – that’s a guess not fact.
KumaMax works as a gluten molecule degrader. In the stomach, the KumaMax targets the gluten molecule and breaks down the part of gluten that causes the immune reaction before the gluten leaves the stomach. If the gluten is broken down before it can reach the small intestine, then there would be no immune reaction and thus no damage. Pretty cool, right?
In this study, they are using healthy and celiac volunteers to evaluate the drug. Initially they are giving healthy volunteers the drug to determine if the drug is safe and if the drug truly breaks down gluten. The drug is given in 5 increasing doses to determine the maximum feasible dose – maximum dose with minimal side effects. Once the healthy volunteers have concluded, then they start with the celiac group and the same procedure. Here they are trying to determine what the correct dose level should be.
Next, they randomize the healthy and celiac patient populations into drug and placebo and dose groups to confirm their findings. What that means, is that they will test the drug at different dose levels in healthy and celiac patients against placebo. This is the testing to see what dose works against a control.
Because this is a Phase 1 study, they are looking to determine if the drug is safe and what are the side effects. They hope to find that the drug is effective too, but primarily it is about safety. The design of the study really indicates that they are looking for the “maximum feasable dose” or biggest bang for the buck with the least side effects while controlling for the “placebo effect”.
As a quick reminder, the placebo effect is where someone with a disease is feeling better because they believe they are getting something to help with their disease whether they are getting a medicine or not. Antibiotics do not fight viruses. However, some doctors will write a prescription for an antibiotic if they believe someone has a virus because it will make them feel better. This is an example of the placebo effect.
So, that is the KumaMax update. I have an e-mail into the Anaheim site waiting for more information. I’ll update when I get it.
Here is the link to the clinical trial information.