Our Company

Sublimity is 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.

SmPill® 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. We believe that, based on its flexible release profile, SmPill platform technology may be able to deliver a variety of potential drug candidates 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 acid degradation in the stomach, and improve suboptimal pharmacokinetics. Accordingly, we believe 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 other IBD indications, as well as other autoimmune and inflammatory diseases potentially modulated by the gut-body axis.

ST-0529

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, or UC. Intravenous, or IV, cyclosporine is a well-established therapy for severe UC; however, it is underutilized due to concerns related to short- and long-term systemic toxicity. ST-0529 has the potential to overcome the shortcomings of marketed IV and oral formulations of cyclosporine. We believe that orally administered cyclosporine with targeted delivery to the colon could be an attractive alternative for patients who no longer respond to 5-ASAs and/or corticosteroids or who have an inadequate clinical response to conventional or biologic therapies.

We believe that the 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. In addition to our ongoing Phase 2b study in ulcerative colitis, we plan to evaluate ST-0529 in future clinical trials in other IBD indications such as Crohn’s colitis (a subset of Crohn’s disease patients with colitis-like lesions in the colon), 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 multiple sclerosis, or MS.

The company employees more than 50 staff at our offices in Dublin and Tullamore, Ireland, and Solana Beach, California.

Sublimity’s proprietary SmPill® technology is a versatile delivery system for solubilizing active therapeutic agents that are otherwise poorly soluble due to their molecular properties.