Ventyx Biosciences Announces First Patient Dosed in a Phase 2 Clinical Trial of VTX002 for the Treatment of Moderate-to-Severe Ulcerative Colitis
December 06, 2021 at 08:00 am EST
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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.
Ventyx Biosciences, Inc. is a clinical-stage biopharmaceutical company. The Company is focused on developing a pipeline of small molecule product candidates to address a range of inflammatory diseases with unmet need. The Companyâs pipeline includes VTX002 (S1P1R Modulator), VTX958 (TYK2 Inhibitor), and VTX2735 and VTX3232 (NLRP3 Inhibitor Portfolio). VTX002 is a sphingosine 1 phosphate receptor (S1P1R) modulator in Phase II development for patients with moderately to severely active ulcerative colitis (UC). VTX958 is an oral, selective clinical-stage inhibitor of tyrosine kinase type 2 (TYK2), an intracellular signaling kinase in the Janus kinase (JAK) family that regulates chronic inflammation in immune-mediated diseases. Its third product candidate, VTX2735, is a peripheral-targeted NOD-like receptor protein 3 (NLRP3) inflammasome inhibitor. In addition to VTX2735, it is also developing VTX3232, its lead CNS-penetrant NLRP3 inhibitor in Phase 1 development.