About Us
We are a clinical stage biopharmaceutical company leveraging our proprietary SmPill platform technology to develop a pipeline of novel oral therapeutics for inflammatory bowel disease, as well as other autoimmune and inflammatory diseases potentially modulated by the gut-body axis for which there is a high unmet medical need. Our lead product candidate, ST-0529, is an orally delivered colon-targeted SmPill formulation of cyclosporine for the treatment of moderate to severe ulcerative colitis.

More information on the AURORA study, including participating research sites can be found here in the Crohn’s & Colitis Foundation’s Featured Research section.

The AURORA Study is Now Enrolling!
Technology
We are leveraging our proprietary SmPill platform technology to design and develop a pipeline of oral drug candidates targeting UC and other IBD indications, as well as other autoimmune and inflammatory diseases potentially modulated by the gut-body axis.
SmPill®
Our product candidate pipeline is built on our patented Single Multiple Pill, or SmPill, oral drug delivery technology. SmPill platform technology is designed to improve shortcomings in current drug formulation, including solubility and bioavailability, by keeping active pharmaceutical ingredient, or API, in a soluble state within a solid minisphere. We believe SmPill platform technology is able to deliver small-molecules, peptides and potentially biologics, including antibodies and other proteins, which are otherwise difficult to administer orally.
Pipeline
We believe that oral delivery of ST-0529 as well as other GI-targeted therapeutics have the potential to be transformative in treating a broad range of immune-mediated diseases. We plan to evaluate ST-0529 in future clinical trials in other IBD indications such as Crohn’s colitis, pediatric UC and pouchitis. Additionally, we are exploring ST-0529 for the treatment of other autoimmune and inflammatory diseases potentially modulated by the gut-body axis, with an initial focus on psoriasis and MS.
IBD and Ulcerative Colitis
Globally, the IBD patient population is estimated at 7 million. Ulcerative colitis (UC) affects approximately 900,000 people in the United States, 1.5 million people in Europe, and over 3 million people worldwide. Of these UC patients, approximately 45% to 55% have moderate to severe disease.
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