Compared to life-threatening conditions like cancer, inflammatory and immune system diseases are understudied. Most can't be cured, yet these diseases are common and seriously affect patients' quality of life. What’s more, scientists increasingly understand that inflammatory processes — while not themselves fatal — often underlie more serious conditions. What are the challenges of drug development for inflammatory diseases? Gregory S. Moss, Esq., Chief Corporate Strategy and Legal Officer at Evommune, a company advancing therapies for chronic inflammatory diseases, shares his insights.
CURE: Why do you think inflammation and immune-mediated inflammatory diseases don't get the same attention as cancer, for example?
Moss: The therapeutic development of inflammatory diseases and immunology in general is in its adolescence. If you think about the last 100 years of cancer treatments, the evolution has been profound. When we look at inflammatory diseases and immunology, drug development is only decades old. But we're seeing a focus and a shift toward inflammatory diseases. Importantly, I think people are recognizing more and more the role that inflammation plays ultimately in the cause of other diseases including cancer.
Perception also is a big issue. Inflammatory diseases probably don't get the attention of diseases like cancer and others where people think, wow, that's fatal. As the world becomes more and more aware that inflammation is likely the cause of a number of more serious or fatal diseases, things are changing.
Cure: Evommune’s vision is to evolve the future of immunology. What does that mean?
Moss: Efficacy and safety need to be the baseline. Then we look at developing programs that can reach more patients earlier in their treatment continuum. We don't presume to be able to prevent disease. But if we can get to the disease earlier, we can then have a profound impact. Look at atopic dermatitis as an example. If you can get to those mild to moderate patients earlier on, you can prevent them from progressing to moderate or to severe, ultimately preventing a huge cost to the healthcare system. But most importantly, you can then stave off some of those comorbidities that might come along later as a result of the inflammation that caused that original atopic dermatitis.
Cure: Does immunology have special challenges for drug development that other therapeutic areas don't have?
Moss: Typically, immunological diseases and disorders have huge patient populations, which ultimately means you need to, over the life cycle of a drug's development, have a huge number of clinical studies, whereas with a rare disease or with aspects of cancer, you could probably get fast track approval, a breakthrough designation and things that'll allow you to conduct smaller studies. When you think about atopic dermatitis, or if you think about some of the mast-cell-mediated diseases that we're looking at, they're big indications. So, companies like Evommune need to be thoughtful about how they get to proof of concept.
They then need to factor in all these other things that we're super cognizant of, but at the same time struggle to allocate mindshare to— like the impact of reference pricing in different countries. All of those things go into challenging your researchers to come up with targets that make sense for the organization, and that's not an easy thing to ask of them.
Cure: Another challenge has been that most of the therapies in immunology have been biologics, which are wonderful, but difficult to administer.
Moss: Biologics certainly have changed the space of immunology. I think as we move more and more to understand how each patient is incurring their disease and the heterogeneous nature of a number of these diseases, we're going to tailor treatment. The healthcare system in the United States cannot fund biologics for every patient. I think there's going to be a need to push toward small molecules and to push toward topicals and ways that you can treat the full spectrum of patients, knowing that for those patients who do get really, really sick, there are wonderful options of biologics.
Today, we're less focused on modality and more focused on target and increasing our reach in those patients. If we think it makes sense to deliver a specific drug topically or through a biologic or through a pill, then we'll focus on that modality. But we will let science decide that.