ST-0529 is an oral formulation of cyclosporine that is being developed for the treatment of moderate to severe ulcerative colitis. ST-0529 has been designed using Sublimity’s proprietary SmPill® delivery system.

Unlike conventional oral or intravenous cyclosporine, SmPill technology enables precise delivery of cyclosporine directly into diseased tissue in the colon. This unique approach provides high local availability of active drug at the site of disease while minimizing systemic exposure which has the potential to limit unwanted side effects. A prior Phase 2a study in more than 100 patients with mild to moderate ulcerative colitis demonstrated that ST-0529 is safe and well tolerated.

The drug is being developed via the 505(b)(2) pathway and is currently being evaluated in CYC-202, a global Phase 2b study involving approximately 280 patients with moderate to severe UC.

Cyclosporine & Ulcerative Colitis

The efficacy of intravenous cyclosporine in managing steroid-refractory ulcerative colitis is well documented with approximately 80% of acute severe patients achieving a disease response and maintaining an effect comparable to anti-TNF therapy1,2. In head-to-head studies with Remicade (infliximab), cyclosporine demonstrated similar efficacy; however serious side effects severely limit the drug’s utility as a long-term treatment option.

With improved convenience and favorable safety profile, ST-0529 has the potential overcome the limitations of conventional cyclosporine and to transform how ulcerative colitis is managed by offering patients a safe, efficacious, and cost-effective alternative to biologics and to obviate the need for steroids.

ST-0529 is currently under clinical development and is not approved as safe and effective for use by the FDA, or any Regulatory agency.

1. Ordas et al. Am J Gastro 2017

2. Laharie et al Lancet, 2012

SmPill® technology enables precise delivery of cyclosporine directly into diseased tissue in the colon.