Citeline, the world's leading research authority on pharmaceutical clinical trials and intelligence recently completed a comprehensive review of clinical trial starts in the autoimmune/inflammation therapeutic area to uncover trends and patterns regarding drug development. Over the one-year review period (September 2009 through October 2010) Citeline analysts uncovered the following developmental trends:

- Year over year clinical trial starts in autoimmune/inflammation remained static (2010 vs. 2009)
- Focus has shifted from rheumatology to respiratory diseases
- COPD and Asthma saw the highest levels of activity
- Inhaled combinations therapies dominate respiratory developments
- All of the top five pharmas (AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Novartis, Pfizer) started new trials in respiratory disorders
- Novartis is by far the most active competitor in the A/I area

"In straightforward numeric counts of trial starts, 2010 does not, on the surface, look like an inspirational year for A/I," stated to Dr. Laura Runkel, Associate Director for Citeline. "However, it has been anything but static with the focus moving from rheumatology to respiratory indications, and particularly high levels of interest in COPD and asthma." Active trials in COPD are now outstripping those in asthma. This trend is driven by several major programs for fixed-dose combinations (FDCs) of LABA/LAMA sponsored by Novartis and GSK.

"There is a clear battle for market share in chronic indications going on between the leading companies: 71% of the top sponsors' trial starts were in respiratory diseases and rheumatology. In contrast, only one of the top 10 sponsors, Novartis, initiated studies in the lower-activity indications including cystic fibrosis, the gastrointestinal indications, and atopic dermatitis." Dr. Runkel continues.

Novel drugs show promise

Several drugs with novel mechanisms of action are being developed in the autoimmune/inflammation therapeutic area, including Pfizer's tofacitinib for rheumatoid arthritis and Vertex's VX-770 and VX-809 for cystic fibrosis. Other promising novel biologics targeting IL-17 and IL-23 are in earlier stages of development currently.

In addition, GSK and Human Genome Sciences completed phase III trials of their novel BLyS-specific inhibitor, Benlysta, in lupus during the period under study; the drug received regulatory approval in the United States shortly thereafter, in March 2011. Benlysta is the first in this new drug class, and is also the first drug to be approved for lupus in decades.

Although clinical trial starts in the autoimmune/inflammation disease area leveled off year-over-year, there were several significant shifts in development paradigms. In particular, the exploration of novel targets in rheumatology, lupus, and cystic fibrosis signifies that industry leaders remain interested in breaking ground in this area. Coupled with the heightened focus on COPD and other trends discussed in the InCite analysis, the development of drugs for these novel targets indicates that A/I is a hot topic on major Pharma's radar.

Source:
Citeline