SP-6310

SP-6310 is an orally bioavailable, potent, and selective small molecule agonist of G protein-coupled receptor 35 (GPR35), a target that has been genetically and functionally linked to the pathogenesis of inflammatory bowel disease (IBD). Discovered by Sosei Heptares using its proprietary StaR® (Stabilized Receptor) platform and licensed to Speranza Therapeutics in 2021, SP-6310 is designed to activate GPR35 receptors primarily expressed in the gastrointestinal epithelium and immune cells. Activation of this receptor is thought to promote mucosal healing, strengthen the intestinal barrier, and modulate local inflammatory responses, offering a potentially differentiated mechanism of action compared to existing IBD therapies. Speranza Therapeutics has completed a Phase 1 clinical trial (NCT05564143) evaluating the safety, tolerability, and pharmacokinetics of SP-6310 in healthy volunteers, which demonstrated a favorable profile and supported its continued development for ulcerative colitis and Crohn's disease.