Ventyx Biosciences Announces First Patient Dosed in Phase 2 Clinical Trial of VTX002 for the Treatment of Moderate-to-Severe Ulcerative Colitis
Ventyx Biosciences, Inc. recently announced 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).
“S1P1 receptor modulators are an important emerging class for patients with moderate-to-severe ulcerative colitis, many of whom continue to experience significant burden from their symptoms and have limited oral treatment options available,” said William Sandborn, MD, Chairman of the company’s Clinical Advisory Board. “VTX002 demonstrated robust lymphocyte lowering and rapid lymphocyte recovery in a Phase 1 trial in healthy subjects. I look forward to seeing the results of the VTX002 Phase 2 program, which is designed to confirm its differentiated efficacy and safety profile in patients.”
“Advancing VTX002 into a Phase 2 trial marks another significant milestone for Ventyx and speaks to the team’s ongoing commitment to advance innovative new therapies for patients,” said Raju Mohan, Chief Executive Officer of Ventyx. “Given the large addressable market for ulcerative colitis, we believe VTX002 has the potential to make a meaningful difference for the approximately one million patients in the US afflicted by this disease.”
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 is a clinical-stage biopharmaceutical company focused on advancing new therapies for millions of patients living with inflammatory diseases and autoimmune disorders. In addition to VTX002, our clinical-stage pipeline includes VTX958, a Phase 1 allosteric TYK2 inhibitor for the treatment of a broad range of autoimmune diseases and VTX2735, a Phase 1 peripheral inhibitor of the NLRP3 inflammasome, which is a mediator of multiple inflammatory conditions. Ventyx is headquartered in Encinitas, CA. For more information, visit www.ventyxbio.com.
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