Crohn's treatment repackaged into pill

Crohn’s and Ulcerative colitis - the two main types of inflammatory bowel disease - Infliximab is the first-choice biologic treatment to control the disease. This therapy is usually administered by intravenous infusion, requiring 2 hours in hospital each time, which can be painful, invasive, and cause adverse effects. Now, non-for-profit organisation CPI are working with Intact Pharma to successfully repackage the biologic drug infliximab into a more effective and more convenient oral capsule. Julia Ravey spoke with Dr Vipul Yadav, CEO of Intract Pharma, and Louise Barker from CPI, who lives with Crohn’s herself…

Louise - There's a saying that no two people experience Crohn's or colitis in the same way. In essence, it does affect you on a day-to-day basis. It can affect pain levels, fatigue, and other common symptoms that come through with Crohn's and colitis is bleeding, having things like abscesses, fissure, fistulas, which can be life threatening, because they cause severe infection and the cause damage through the bowel and into other areas of the body as well. You need injections of certain vitamins. There is no cure. So one of the key things is trying to get your body into remission and that's through different techniques through tablets, biologic treatment or surgery.

Julia - What are the current treatment options that you have if you have Crohn's or colitis?

Louise - For myself at the moment, I take an immunosuppressant in addition to a drug called infliximab, which is currently given intravenously in hospital. And I have the two drugs together as a dual therapy, which in essence, when you take the infliximab intravenously, your body can actually build up antibodies to it, which makes it less effective and your body doesn't respond to it. I take immunosuppressants, a drug called azathioprine, which then suppresses my immune system so my immune system doesn't end up actually creating that antibody to it. The idea is that will make it more effective. However, there are consequences of doing that, unfortunately, because what that means is that your body is severely compromised in terms of an immune system.

Julia - It sounds like a complex form of treatment that not only impacts your health in other ways, but also it's potentially quite invasive if you're having to have intravenous treatment. So Vipul, how are we trying to revolutionise this treatment?

Vipul - Our company's focused on developing a pill-based form for these drugs that currently patients like Louise have to go to a hospital and take an infusion for hours. We are trying to develop a pill-based technology that takes that drug out of that injection into a pill that you can take at home. Our technology is designed to release this potent medicine directly at the site of your intestine where the disease is, and it prevents the drug from getting into your circulation, so you don't get all the adverse effects and potentially, your immune system creating antibodies against the drug. We completely prevent that.

Julia - How do you target it to the disease site?

Vipul - It's like a film quoting that you can apply on the outside of a tablet or a capsule and that film quoting will prevent this drug from being released in your stomach and your upper small intestine where you digest food and absorb nutrients. We bypass that entire region with the help of that film coating and that coating only dissolves in your large bowel, where you have the right conditions like the pH and the bugs, and that's where the drug is released and gets taken up.

Julia - Where are we at with this drug?

Vipul - So we are still at the testing stages, but what we as a company have done is partnered with another big company who is already manufacturing this drug in the form of an injection. So we are partnering with them to take that already effective drug as an injection to then apply that into our pill form. So we are currently scaling this technology up and that's where we collaborated with CPI, the consortium who really helped us in optimising the formulation of this capsule and developed the manufacturing processes that will help us to take this product quicker into clinical trials.

Louise - For me personally, I just think this treatment could absolutely be revolutionary for patients like me. The key things for me is the travel to and from hospital to have the IV treatment. And that's quite an invasive process to actually have IV treatment as well. You need dedicated IBD specialist nurses with you when you’re having that treatment. We go for a blood test before we're about to have that as well to make sure that there's no infection in the body. On top of that, as I said earlier, I'm on immunosuppressants, which means that I actually do alter my behaviour because of those immunosuppressants. Going on holiday, for example, I was just explaining that I tend to look for where would the nearest hospital be if I did get an infection, what kind of travel routes I want to take to minimise contact and things like that. You do alter your behaviour with the treatment that you are on. So the thought for me of just being able to have a tablet, which means I don't need immunosuppressants, I don't need to travel into hospital and I can literally just wake up on a morning, go downstairs and take my tablet for me, could actually be life-changing, as corny as that might sound, but it is actually quite a life-changing treatment for people like me