After some new biologics entered clinical trials at the beginning of the year, things have been quiet on the clinical testing front. That has just changed, as two new investigative drugs have entered the market: UCB5857 and LY3090106.
LY3090106 first appeared in a phase 1 clinical study for rheumatoid arthritis in 2013. That study completed in September, and was presumably successful, as Eli Lily, the maker of the drug, has opened an additional trial for SS. I haven’t been able to gather any information on the drug in question, aside from the fact that it is a biologic agent. As a phase 1 trial, this study will only be evaluating the safety and absorption of the drug; there will need to be additional phase 2 & 3 trials to study how effective it is. As a result, this drug is many years away from potential use on the market.
UCB5857 is a little further along as a phase 2 study that is currently recruiting (in Europe), having completed a phase 1 study in March. There is more information available about this experimental drug. It is not, like most recent auto-immune treatment drugs, a biologic agent. Instead, it is a kinase inhibitor. From the recently published “Phosphatidylinositol-3-Kinase Delta Pathway a Novel Therapeutic Target for Sjogren’s Syndrome“:
UCB5857, a small molecule inhibitor of PI3Kδ, was used in vivo in an inducible model of ectopic lymphoneogenesis in murine salivary glands that mimics Sjögren’s syndrome… In vivo, we observed a decrease in the number of T and B cells in cannulated salivary glands of mice prophylactically treated with UCB5857… Preliminary data suggest that PI3Kδ is engaged in several cells present in the salivary glands of patients with SS and might contribute to disease pathogenesis. Accordingly, prophylactic and therapeutic blocking of PI3Kδ results in disaggregation of the inflammatory foci and resolution of salivary gland inflammation in an animal model of SS.
Biologic drugs make up the vast majority of potential new SS treatments, so it’s refreshing to see a different angle being taken. UCB5857 could be ready for human use in as few as 5 years, so it is worth keeping an eye on.
Once again, it is refreshing to see pharmaceutical companies including SS testing in the early stages of a new treatment, rather than an after-the-face run of trials after getting approval for a disease with more mindshare, like Lupus or rheumatoid arthritis.