Bringing innovation in IBD treatment and management to patients

Inflammatory bowel disease (IBD) is a group of chronic conditions, affecting over 10 million people worldwide.  One of the most common forms of IBD is ulcerative colitis (UC), which is an increasingly prevalent disease with a significant impact on the quality of more than 2 million people’s lives.

Unfortunately, current treatments aren’t successful for all patients and it is estimated that of those with moderate to severely active disease the vast majority are not satisfactorily controlled. Current therapies can be associated with severe side effects, and often patients do not get the results they want. Therefore, there is a need to develop treatments, effective for a wider population.

To address this unmet need in 2019 Galapagos and Gilead (G&G) began a multi-year research and development partnership in inflammation. Over the next decade, G&G will embark on a journey using combined resources, infrastructure, and experience to accelerate drug discovery efforts and investigate potential new therapies for IBD, for both healthcare professional and patient communities.

Together, Galapagos and Gilead are committed to advancing the treatment of inflammatory diseases and improving the ongoing patient needs through partnerships and collaborations with the scientific and medical community.

The burden of disease in UC

Ulcerative colitis is a very a difficult disease – and it a disease that affects younger people. The underlying mechanism of UC is the inflammation of the colon, and how this manifests in symptoms can be devastating for sufferers.

The hallmark of UC is having diarrhoea, often bloody diarrhoea, along with a sense of urgency to empty the bowels, both of which can have a huge impact on patients’ lives. It is terrifying to experience this when you are away from home and don’t have quick access to a restroom.

Some people deal with this by isolating themselves or limiting what they do in order to avoid having an episode of urgent diarrhoea when they are not near a toilet.  Of course, it doesn’t happen to patients all the time – they can go through periods where they are doing better – but then suddenly, they may experience flare ups.

Unfortunately for some, they never manage to get this chronic condition under control– and this is really limiting and life-changing. Some even change their careers and plans.

In the case of UC, because it hits younger people, it means they have a much longer time to live with it – and therefore also a higher chance to develop longer-term complications, which can include cancer.

One of the biggest challenges with a young patient demographic is that they tend not to be as diligent getting treatment and sticking to it. Often at that age, in their late teens to twenties, they feel invincible, so they may have a flare up, but then they take a course of steroids, and feel better – so they leave it and move on with their lives. But the problem is, this is a chronic disease and it will come back. Every bout has the potential to increase longer-term problems for the individual, however young adults, generally don’t think of these longer-term consequences. Once they feel better, they forget about it and this is one of the biggest challenges.

We need to improve awareness of the disease when it comes to treatment and find a better way to engage with the younger population, so that they can truly see the benefit of taking adequate and effective medicines that are going to improve the longer-term consequences of UC.

In many trials, measuring the proportion of people who manage to get control of their UC with the medicine we use – and without the use of steroids – becomes a clinically meaningful endpoint that we pay attention to.

Why innovation is so important in this patient population

It is so important to have new medicines that will truly make a large difference to patients, especially when they have an acute flare up.

Currently when you look at the efficacy of available treatments out there, and you measure factors such as remission, the rates vs placebo are 10%-15% at best. That is very low. We need to do better for these patients and get those numbers up. One can aspire to reach 60-80% response in patients after 10 or 12 weeks of treatment.

Our aim for UC is simple and clear – that bar needs to be set higher. There is a huge amount of innovation that needs to be done. We need to better understand the flare ups, we need to better understand how we can intervene and stop this disease, and essentially make it a minor nuisance, rather than an all-encompassing condition.

Applying the Galapagos philosophy to UC

At Galapagos, we take a very scientific approach where we look at the biology of the disease, we try to understand the pathways, and we identify targets that will link to those pathways using our innovative drug discovery platform.

There is a very close link between our scientists in the laboratory, and our scientists in the clinic, who are working on a number of promising compounds in our pipeline, including a completely novel class of compounds we call Toledo, because we have not yet disclosed the mechanism of action. Additionally, we have recently disclosed promising phase 3 results for a second generation JAK1 preferential inhibitor, that we hope will lead to successful licenses around the world for a new therapy to treat UC, so that we can continue to improve on where we are right now.

The difference I want to make

For me, beyond doing what is necessary for regulatory approval by the health authorities for new treatments, I would like us to take the UC patient with us on our journey to discover and develop treatments for this cruel disease, to understand what is really important to them, how we can develop medicines to address their needs and develop the right tools to measure these factors in our studies, and show we can make a difference to the things that really matter to them.

Galapagos and Gilead: Set up for future success

Galapagos and Gilead share commons values around science and innovation for patients. We also have different strengths and areas of focus that are complementary – but we are both driven by the need to address the unmet need for patients. We go after the diseases that some companies may shy away from because the chances of success seem low. We trust our science and our biology, and we go after targets that we think can make a big difference to the quality of patients’ lives. I am excited by what the future will bring as we continue to share our scientific knowledge and goals to develop medicines that change the course of disease for UC patients.