Ventyx Biosciences, Inc. announced that the first patient has been dosed in a Phase 2 randomized, placebo-controlled trial of VTX002 for the treatment of moderate-to-severe ulcerative colitis (UC). In a Phase 1 multiple ascending dose trial in healthy volunteers, VTX002 was well tolerated at all doses tested with no serious adverse events. In addition, VTX002 demonstrated a dose-dependent steady-state reduction in absolute lymphocyte count of up to 65%, which is a well-established biomarker for S1P1 receptor-mediated diseases. The Phase 2 trial is a randomized, placebo-controlled, clinical trial in moderate-to-severe UC patients. The trial design includes a 13-week induction treatment period followed by a 39-week open label extension (OLE) with a primary efficacy endpoint of clinical remission at Week 13 as defined by the 3-Component Mayo Score. VTX002 is a peripherally-restricted, potent and selective, orally bioavailable small molecule modulator of the S1P1 receptor. Discovered by the Ventyx team, VTX002 has the potential to improve therapeutic benefit in autoimmune diseases, such as ulcerative colitis. S1P1 receptors play a central role in the regulation of lymphocyte trafficking from lymph nodes to the peripheral blood. S1P1 receptor modulators, such as VTX002, sequester lymphocytes in the lymph nodes, resulting in fewer immune cells in the circulating blood to exacerbate inflammation.