How New Therapies are Tackling Unmet Needs in IBS

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 Sciences, 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: Is there a persistent unmet need for new therapies for IBD?
Christien Thienel: Ulcerative colitis and Crohn's disease are two of the most active therapeutic areas in all of biopharma, and they have attracted significant investment from both large pharma and smaller biotech. When people think about IBD treatment today, they think about Humira, Remicade, and increasingly Rinvoq and other JAK inhibitors. But historically, injectable therapies have dominated the landscape.

Opinions on how effective and safe those products are vary depending on who you ask. Generally speaking, physicians are relatively satisfied with TNF inhibitors in this space. But particularly in Crohn's, and to a meaningful extent in UC as well, those therapies are not altering the course of the disease. They represent a major advance over the older generics used in this population for many years — but one of the key findings from the research we did going into this paper is that substantial unmet need persists around what to do beyond a TNF inhibitor. Options for effective mechanisms of action beyond that class remain limited.

The landscape has expanded somewhat. Integrins like Entyvio and several other products offer comparable efficacy to TNF inhibitors. But the need that really persists is an oral product that balances efficacy and safety in a way that currently doesn't exist in this space. That product doesn't necessarily need to match biologic-level efficacy — it could potentially be somewhat less efficacious — if it offers a meaningfully improved safety profile to support that trade-off.

There's been a lot of excitement around Rinvoq, and commercially it has been extremely successful. But one of the consistent findings from our KOL interviews and the survey we commissioned was significant concern about the black box warning and the safety profile associated with JAK inhibitors more broadly. So the unmet need we see is clear: something with biologic-like efficacy but an improved safety signal. And the oral delivery advantage remains a major differentiator in this space, where very few options currently exist.