Challenges in Inflammatory Disease Drug Development
- mtallin
- Jun 5, 2024
- 2 min read
Updated: Jul 16, 2024
The days of multi-billion dollar blockbuster drugs in inflammatory diseases are likely behind us as the availability of generics and biosimilars continues to rise. Great news for patients, but challenging for companies working in this space.
There are a number of challenges that are now commonplace in Inflammatory Disease Drug development that weren’t an issue 20 years ago. Here we have used ulcerative colitis (UC) as an example disease but the same is true for all inflammatory diseases.
Achieving Endpoints in patients who are not treatment naive
As more and more patients are exposed to targeted treatments, the threshold for success continues to evolve. When the TNF inhibitors were first developed there were no patients who had previously been put on targeted treatments and therefore the magnitude of effect was generally higher than seen today (see Fig 1.). For drug developers today, it’s hard to beat clinical remission in >25% of patients.
Figure 1. Clinical Remission at Induction Note: Endpoints definitions and weeks of induction may vary slightly between products. Best clinical remission score used if multiple trials reported
Logistical Issues
The availability of many new targeted therapies (see Fig 2.) means that patients are less likely to enroll in a trial if there are new products available that they have not tried yet. This, along with the competition in the space, means that companies are reaching out to conduct trials further afield in areas such as Eastern Europe where there are fewer patients who have been exposed to targeted therapeutics. This may not be optimal for a number of reasons. Firstly, while patients are more likely to be targeted therapy naive, treatment practices and attitudes to healthcare may not be the same as the US and Western Europe. Secondly, for every new country where a patient is recruited new regulatory pathways, translations and supply logistics need to be set up.
Figure 2. – UC targeted drug approvals over time
Return on Investment
With many drugs going generic/biosimilar any new therapies are more and more likely to be relegated to 4th, 5th or later lines of therapy. Oftentimes the revenues seen in these later lines of therapy may not justify investment in what are, typically, very large and expensive trials. Larger players with existing trial networks may be at an advantage here. In addition, companies with existing portfolios can offer combination trials with their approved agents, something that is more challenging for smaller companies to pull off.
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