An estimated 15+ million Americans live with immune-mediated inflammatory diseases (IMID) including psoriasis and Crohn’s disease (CD) and ulcerative colitis (UC), two forms of inflammatory bowel disease (IBD). Many of these patients do not respond to treatment or fail treatment after several years.
In light of these and other challenges, there is a need to equip patients and the physicians who treat them with new and improved treatment options. One area of emerging interest and opportunity is in transitioning from biologic treatment modalities, such as monoclonal antibodies, to oral approaches.
Patients Require More Options
With the advent of monoclonal antibodies, key inflammatory pathways that are driven by cytokines — signaling molecules released by cells that can drive inflammation — can be inhibited. These IV/injection treatments have revolutionized treatment of immune-mediated inflammatory diseases. However, while many patients achieve relief that lasts for a few years, there is a pharmacologic element inherent with antibody-based approaches in which patients can develop antibodies that can neutralize therapeutic effect. It is one of many reasons why patient need remains high.
What’s more, we know that challenges come with administering drugs by injection, including a loss of patient adherence. Unfortunately, current oral therapies can be profoundly immunosuppressive and chronic use can cause severe side effects. That is why an oral cytokine inhibiting medication could be transformational for patients — both in terms of potentially avoiding the loss of efficacy attributable to anti-drug antibodies and delivering a desirable safety profile. Oral cytokines inhibitors could create access to medicines that work not only in the lab, but in patients’ lives.
Enhancing Innovation Through Collaboration
Developing safe and effective oral cytokine inhibitors comes with its challenges. In a normally functioning inflammatory system, cytokines are released in response to infection or injury. For patients with IMIDs like psoriasis and IBD, the cytokine release and inflammatory system is stuck in the “on” position. Cytokines interface with inflammatory cells through large protein-protein interactions, which makes it very difficult for small molecules, like potential oral cytokine inhibitors, to interrupt this binding.
Through our collaborations, we are building on our deep pathway insights acquired over the last 20 years developing expertise in the interleukin pathways to fundamentally advance oral cytokine inhibitors. We are not only identifying small molecules that have the capacity to interrupt those large protein-protein interactions. We are also seeking to ensure they can survive the hazards of the stomach and permeate through the body and tissues.
While we still see injectable biologics as an important and established approach for patients, we see the expansion of future oral targeted therapy options as critical to addressing the patients’ unmet need. In just the last decade, we have seen the treatment landscape change quite dramatically and we expect that in the years to come it will continue to evolve. There is immense innovation going on in the immunology therapeutic space and collaboration between biotech and biopharma seeks to create new opportunities and options for patients. It is the intersection of innovation, deep expertise, and development capabilities, where we can have a profound impact on patients’ lives.
To learn more about Janssen’s mission and its collaborations, please visit https://www.janssen.com/immunology/partnerships. Janssen’s oral cytokine inhibitor candidate is currently in Phase 2b clinical trials to evaluate its safety and efficacy in the treatment of moderate-to-severe plaque psoriasis. This study commenced on February 3, 2022, and is expected to enroll 240 participants. More information on the trial can be found at clinicaltrials.gov.