Advancements in Oral Treatments for IBD

In 2024, Pharmaceutical Executive reported on a survey that showed a significant number of patients suffering from irritable bowel disease (IBD) struggle to afford proper healthcare. According to the results, treatments became unattainable due to barriers such as financial challenges and insurance issues. Many patients also struggled with adverse health impacts.

At the time, the Crohn's & Colitis Foundation president and CEO Michael Osso said, “These findings underscore the urgent need to address healthcare disparities in IBD care. Despite our progress in IBD research and treatment options, many patients still struggle to access the care they need without facing undue burden. Our survey findings highlight the critical need for reforms to ensure that IBD patients can access the medications they need without undue financial hardship."

Recently, Pharmaceutical Executive spoke with Christian Thienel, director at Back Bay Life Science Advisors, about the ongoing issues with IBD treatments. While the original survey focused more on the financial barrers, Thienel’s conversation looked at treatment and R&D barriers which allow for persistent unmet needs to impact patients.

Pharmaceutical Executive: What advancements are being made for oral treatments of IBD?
Christian Thienel: There are a number of emerging mechanisms worth discussing. We cover SIK2 inhibition in some depth in the paper — that's the mechanism Nimbus is working on — and I think it has some distinctive advantages. It not only reduces the activity of pro-inflammatory cytokines, but also has an effect on IL-10 and a mucosal healing mechanism that I think is a missing piece in a lot of the single cytokine-based approaches available today.

Oral IL-23 inhibitors are also generating real excitement, particularly with the recent approval of icotrokinra. The IL-23 mechanism is very well validated in the space, and the efficacy and safety data have been impressive. That said, as we've seen with the injectable IL-23 inhibitors, the single cytokine approach may not solve all the problems. My hunch is that it probably won't — but icotrokinra is nonetheless expected to be a very successful product.

There are also microRNA regulators discussed in the paper that have shown some interesting clinical signals, and TYK2 inhibitors have progressed considerably. The TYK2 program that Nimbus developed with Takeda is primarily advancing in psoriasis as a lead indication, but there has been meaningful development activity around the TYK2 pathway in IBD as well.

There is clearly a lot of activity in this space, which reflects what we saw from the market research: the unmet need on the oral side is significant. The question is which of these mechanisms will best address what we believe are the fundamental remaining gaps — and each has its own set of advantages that will play out in the clinic.