SDL-001

SDL-001 is a proprietary drug delivery formulation developed by Surmount Services, Inc., designed to facilitate the transcolonic delivery of large molecule biologics, such as monoclonal antibodies. It functions as a permeation enhancer intended to enable the direct administration of therapeutic proteins to the colonic mucosa, thereby achieving high local drug concentrations for the treatment of inflammatory bowel disease (IBD) while potentially minimizing systemic exposure and associated side effects. The formulation has been evaluated in Phase 1 clinical trials in combination with adalimumab (an anti-TNF antibody) and guselkumab (an anti-IL-23 antibody) to assess its safety, tolerability, and pharmacokinetic profile in healthy adult participants.