We are leveraging our proprietary SmPill technology to design and develop a pipeline of oral drug candidates targeting UC and IBD indications as well as autoimmune and inflammatory diseases potentially modulated by the gut-body axis. Our clinical development pipeline and discovery programs are depicted below:
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 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. We believe that, based on its flexible release profile, SmPill platform technology may be able to deliver a variety of drugs in a targeted fashion within or throughout the GI tract or to be absorbed via the GI tract for systemic bioavailability. This combination of solubility and gut targeting offers the potential to enhance gastrointestinal permeability, counter a propensity for acid degradation in the stomach, and improve suboptimal pharmacokinetics. Accordingly, we can modify and predict how and when the drug is absorbed to address a desired therapeutic effect. We are leveraging our proprietary SmPill platform technology to design and develop a pipeline of oral drug candidates targeting UC and IBD indications, as well as other autoimmune and inflammatory diseases potentially modulated by the gut-body axis.
We are currently evaluating ST-0529 in a global Phase 2b clinical trial in patients with moderately to severely active UC. ST-0529 is currently under clinical development and is not approved as safe and effective for use by the FDA, or any Regulatory agency.
SmPill® technology enables precise delivery of an oral calcineurin inhibitor directly into diseased tissue in the colon.
More information on the AURORA study, including participating research sites can be found here in the Crohn’s & Colitis Foundation’s Featured Research section.