Benzinga | Dec 6, 2021 08:03AM EST

Ventyx Biosciences Announces First Patient Dosed In Phase 2 Clinical Trial Of VTX002 For Treatment Of Moderate-To-Severe Ulcerative Colitis

Ventyx Biosciences, Inc. (NASDAQ:VTYX) ("Ventyx" or the "Company"), a clinical-stage biopharmaceutical company focused on advancing new therapies for millions of patients living with inflammatory diseases and autoimmune disorders, announced today 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).



"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 United States 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.