Ventyx Biosciences to Present Phase 2 Trial Data on TYK2 Inhibitor VTX958 for Crohn's at ECCO 2025

Ventyx Biosciences, a biopharmaceutical company focused on developing oral therapies for autoimmune, inflammatory, and neurodegenerative diseases, has announced promising outcomes from its Phase 2 trial of the TYK2 inhibitor, VTX958, for Crohn’s disease. The findings will be presented at the 20th Congress of the European Crohn’s and Colitis Organisation (ECCO) in Berlin.

According to Raju Mohan, PhD, Ventyx's Founder and CEO, while the trial did not meet its primary endpoint concerning changes in the Crohn’s Disease Activity Index (CDAI) due to an unexpectedly high placebo response, significant endoscopic responses were observed. These results were characterized by a robust dose-dependent effect, aligning with improvements in key inflammatory markers such as C-reactive protein and fecal calprotectin. This suggests that VTX958 could potentially serve as a safe and effective treatment for Crohn’s disease, especially given the high unmet need for oral therapeutic options.

Professor Silvio Danese, a gastroenterology expert from Vita-Salute San Raffaele University in Milan, highlighted the importance of the endoscopic responses seen in the trial. He noted that these outcomes, combined with a favorable safety profile, support continued investigation of VTX958 as a potentially disease-modifying treatment for Crohn’s disease.

The Phase 2 trial, which was randomized, double-blind, and placebo-controlled, involved 109 adult participants with moderately to severely active Crohn’s disease. Participants were assigned to receive either a placebo, VTX958 at 225 mg twice daily, or VTX958 at 300 mg twice daily over a 12-week induction period, followed by a 40-week double-blind maintenance phase.

The primary endpoint was the change in CDAI from baseline to Week 12. Although reductions were seen in the CDAI scores for the VTX958 treatment groups, they did not achieve statistical significance due to the higher placebo response. However, reductions in the SES-CD score were statistically significant for both VTX958 doses compared to placebo, indicating significant improvements in endoscopic outcomes.

Endoscopic response rates, defined as a ≥50% reduction in the SES-CD score from baseline, were notably higher in participants receiving VTX958, with 24.3% for the 225 mg dose and 32.4% for the 300 mg dose, compared to just 5.7% for the placebo group. This highlights the dose-dependent nature of the endoscopic response.

Furthermore, a greater proportion of individuals in the VTX958 groups achieved both clinical remission and endoscopic response compared to the placebo group. In the 300 mg VTX958 group, 18.9% of participants reached this combined endpoint, versus only 2.9% in the placebo group. Additionally, a significant number of participants experienced a clinical-biomarker response with VTX958.

These findings are encouraging, particularly in the context of the need for safe oral therapies for Crohn’s disease. The ongoing analysis of data from the 52-week long-term extension phase is expected to shape future development and partnership strategies for VTX958.

Ventyx Biosciences is committed to advancing its diverse portfolio of oral small molecule therapeutics, targeting conditions with high unmet medical needs. The company's expertise spans medicinal chemistry, structural biology, and immunology, which supports the rapid progression of its compounds through clinical trials.