VTX958 / Ventyx Biosci - LARVOL DELTA

Efficacy and safety of an oral tyrosine kinase 2 inhibitor VTX958 in moderately to severely active Crohn’s disease: a randomised, double-blind, placebo-controlled, phase 2 trial (ECCO-IBD 2025) - "Although the primary endpoint of CDAI change from baseline was not met, higher rates for most objective outcomes were observed with VTX958 300mg, including endoscopic response and combined clinical remission and endoscopic response. Additional data are needed to determine the long-term safety and efficacy of VTX958 in CD."

Clinical • P2 data • Crohn's disease • Immunology • Inflammatory Bowel Disease • CRP • TYK2

Ventyx Biosciences Announces Presentation of Data from the Phase 2 Trial of Allosteric TYK2 Inhibitor VTX958 in Crohn’s Disease at ECCO 2025 (GlobeNewswire) - P2 | N=132 | NCT05688852 | Sponsor: Ventyx Biosciences, Inc | "While the primary endpoint was not met, likely due to a higher-than-expected placebo response, improvements in endoscopic results were observed. These improvements were associated with reductions in key inflammatory biomarkers. VTX958 was well tolerated in this Phase 2 trial....Reductions in CDAI from baseline were observed with VTX958 at Week 12 (-134.1 points for VTX958 225 mg; -113.6 points for VTX958 300 mg); however, these results did not reach statistical significance, likely due to a higher-than-expected response in the placebo group (-104.3 points; p>0.05)....Reductions from baseline in the SES-CD score were observed with VTX958 225 mg (-3.5 points, p<0.0001) and VTX958 300 mg (-2.7 points, p=0.0005) compared to placebo (+2.1 points)."

P2 data • Crohn's disease

Harmony-CD: VTX958 for the Treatment of Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P2 | N=132 | Terminated | Sponsor: Ventyx Biosciences, Inc | Trial completion date: May 2027 ➔ Dec 2024 | Active, not recruiting ➔ Terminated; Sponsor Decision

Trial completion date • Trial termination • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease

Ventyx Biosciences Announces Results from the Phase 2 Trial of VTX958 in Participants with Moderately to Severely Active Crohn’s Disease (GlobeNewswire) - P2 | N=132 | Harmony-CD (NCT05688852) | Sponsor: Ventyx Biosciences, Inc | "Ventyx Biosciences, Inc...announced results from the Phase 2 trial of its allosteric TYK2 inhibitor VTX958 in participants with moderately to severely active Crohn’s disease....The trial did not meet its primary endpoint of change in mean CDAI score from baseline to Week 12 due to a higher than anticipated placebo response. A dose-dependent treatment effect was observed on the key secondary endpoint of endoscopic response, at both the 225 mg and 300 mg doses (nominal p-value <0.05 and <0.01, respectively). Endoscopic response, evaluated by centrally read endoscopy, is considered an objective outcome and a high priority treatment goal....At this time, Ventyx does not anticipate conducting additional clinical trials of VTX958 with internal resources."

P2 data • Crohn's disease • Immunology • Inflammatory Bowel Disease

Ventyx, 'TYK2 Inhibitor' Crohn's Disease Phase 2 Trial Fails… "Completely Discontinued" [Google translation] (Biospectator) - "Ventyx Biosciences has halted development of its oral TYK2 inhibitor 'VTX958' after it failed in a phase 2 clinical trial for Crohn's disease (CD)...VTX958 failed to meet the primary endpoint by failing to show statistically significant results in the Crohn's Disease Activity Index (CDAI), a key evaluation index for Crohn's disease symptoms. After the announcement of these results, Ventyx's stock price plummeted 20% from the previous day....However, due to the failure in the phase 2 clinical trial for Crohn's disease, the development of VTX958 was discontinued altogether."

Discontinued • Stock price • Crohn's disease • Immunology • Inflammation • Inflammatory Bowel Disease

Ventyx Biosciences Reports First Quarter 2024 Financial Results and Highlights Recent Corporate Progress (GlobeNewswire) - "We recently completed a productive End of Phase 2 meeting with the U.S. Food and Drug Administration (FDA) and we expect to conduct a Scientific Advice meeting with the European Medicines Agency (EMA) during the second quarter of this year. We intend to identify a partner or other source of non-dilutive financing to support the pivotal Phase 3 trial of VTX002 in UC....VTX958 (TYK2 Inhibitor): We are evaluating VTX958 in a Phase 2 trial in patients with moderately to severely active Crohn’s disease....The trial’s sole primary endpoint is now the change from baseline in the mean Crohn’s disease activity index (CDAI) score at Week 12. We have completed enrollment in the trial, and we expect to report topline results early in the second half of 2024."

Licensing / partnership • P2 data • Crohn's disease • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Harmony-CD: VTX958 for the Treatment of Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P2 | N=132 | Active, not recruiting | Sponsor: Ventyx Biosciences, Inc | Recruiting ➔ Active, not recruiting

Enrollment closed • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease

VTX958 Versus Placebo for the Treatment of Active Psoriatic Arthritis (Tranquility-PsA) (clinicaltrials.gov) - P2 | N=205 | Terminated | Sponsor: Ventyx Biosciences, Inc | Trial completion date: Apr 2025 ➔ Jan 2024 | Recruiting ➔ Terminated; sponsor decision

Trial completion date • Trial termination • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Serenity PsO: VTX958 Versus Placebo for the Treatment of Moderate to Severe Psoriasis (clinicaltrials.gov) - P2 | N=222 | Terminated | Sponsor: Ventyx Biosciences, Inc | Trial completion date: Oct 2024 ➔ Dec 2023 | Active, not recruiting ➔ Terminated; Business Decision

Trial completion date • Trial termination • Dermatology • Immunology • Psoriasis

Ventyx Biosciences Announces Results from the Phase 2 Trial of VTX958 in Patients with Moderate to Severe Plaque Psoriasis and Provides Corporate Update (Yahoo Finance) - P2 | N=222 | SERENITY (NCT05655299) | Sponsor: Ventyx Biosciences, Inc | "Ventyx Biosciences, Inc...today announced results from the Phase 2 trial of VTX958 in patients with moderate to severe plaque psoriasis and provided a corporate update....oth high doses of VTX958 (225 mg BID and 300 mg BID) achieved statistical significance on the primary endpoint and all key secondary endpoints at Week 16. No drug-related serious adverse events were observed. Although the trial achieved its primary endpoint, the magnitude of efficacy observed did not meet our internal target to support advancement of VTX958 in plaque psoriasis. Accordingly, we will terminate ongoing activities in the Phase 2 plaque psoriasis trial effective immediately. Based on these results, we have also elected to terminate the ongoing Phase 2 trial of VTX958 in psoriatic arthritis."

P2 data • Trial termination • Immunology • Psoriasis • Psoriatic Arthritis

Ventyx Biosciences Reports Third Quarter 2023 Financial Results and Highlights Recent Corporate Progress (Yahoo Finance) - "The ongoing Phase 2 trial of VTX958 in Crohn’s disease will continue with the addition of an interim efficacy analysis to be conducted in the first quarter of 2024."

P2 data • Crohn's disease • Immunology • Inflammatory Bowel Disease

Serenity PsO: VTX958 Versus Placebo for the Treatment of Moderate to Severe Psoriasis (clinicaltrials.gov) - P2 | N=200 | Active, not recruiting | Sponsor: Ventyx Biosciences, Inc | Trial completion date: Feb 2024 ➔ Oct 2024

Trial completion date • Dermatology • Immunology • Psoriasis

Serenity PsO: VTX958 Versus Placebo for the Treatment of Moderate to Severe Psoriasis (clinicaltrials.gov) - P2 | N=200 | Active, not recruiting | Sponsor: Ventyx Biosciences, Inc | Recruiting ➔ Active, not recruiting

Enrollment closed • Dermatology • Immunology • Psoriasis

Ventyx Biosciences Announces Completion of Enrollment of the Phase 2 Trial of VTX002 in Ulcerative Colitis and the Phase 2 Trial of VTX958 in Plaque Psoriasis (GlobeNewswire) - "Ventyx Biosciences, Inc...announced that the Company has completed patient enrollment in the Phase 2 trial of VTX002 in ulcerative colitis and the Phase 2 SERENITY trial of VTX958 in plaque psoriasis....'We look forward to reporting topline data from the Phase 2 trial of VTX002 in ulcerative colitis early in the fourth quarter of 2023, followed by topline results from the Phase 2 SERENITY trial of VTX958 in plaque psoriasis, which are also expected in the fourth quarter of 2023.'...In addition to the Phase 2 SERENITY trial, Phase 2 trials of VTX958 continue to enroll patients in moderately to severely active Crohn’s disease (HARMONY) and in active psoriatic arthritis (TRANQUILITY), with topline results from both trials expected in 2024."

Enrollment closed • Enrollment status • P2 data • Crohn's disease • Immunology • Inflammation • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis

VTX958 Versus Placebo for the Treatment of Active Psoriatic Arthritis (Tranquility-PsA) (clinicaltrials.gov) - P2 | N=195 | Recruiting | Sponsor: Ventyx Biosciences, Inc | Trial completion date: Mar 2024 ➔ Apr 2025

Trial completion date • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Harmony-CD: VTX958 for the Treatment of Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P2 | N=132 | Recruiting | Sponsor: Ventyx Biosciences, Inc | Trial completion date: Jul 2024 ➔ May 2027

Trial completion date • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease

Ventyx Biosciences Reports Fourth Quarter and Full Year 2022 Financial Results and Highlights Recent Corporate Progress (Yahoo News) - "VTX958 (TYK2 Inhibitor): Enrollment is ongoing in the Phase 2 SERENITY trial of VTX958 in moderate to severe plaque psoriasis, the Phase 2 HARMONY trial in moderately to severely active Crohn’s disease and the Phase 2 TRANQUILITY trial in active psoriatic arthritis. Topline data from the Phase 2 SERENITY psoriasis trial are anticipated in Q4 2023. Topline readouts from the Phase 2 HARMONY and Phase 2 TRANQUILITY trials are expected in 2024....VTX002 (S1P1R Modulator): We continue to make significant progress enrolling the Phase 2 trial of VTX002 in moderately to severely active ulcerative colitis. We expect to complete enrollment by mid-2023 and topline results are anticipated in the second half of 2023."

Enrollment status • P2 data • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis

"The $VTYX Dream 1) TYK2 coverage: VTX958 175 mg BID > NDI-034858/TAK-279 30mg QD (Nimbus $TAK) 2) Dose dependent efficacy: NDI-034858/TAK-279 psoriasis PASI-100 data #AAD23" (@BayAreaBiotechI)

Clinical • Dermatology • Immunology • Psoriasis • TYK2

VTX958 Versus Placebo for the Treatment of Active Psoriatic Arthritis (Tranquility-PsA) (clinicaltrials.gov) - P2 | N=195 | Recruiting | Sponsor: Ventyx Biosciences, Inc

New P2 trial • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Ventyx Biosciences Announces Pipeline Updates and Highlights Strategic Priorities at Investor R&D Day (GlobeNewswire) - "Enrollment is ongoing in the Phase 2 SERENITY trial of VTX958 in moderate-to-severe plaque psoriasis...while screening activities have initiated for the Phase 2 TRANQUILITY trial in psoriatic arthritis. Topline data from the Phase 2 SERENITY psoriasis trial are anticipated in Q4 2023. Topline readouts from...TRANQUILITY trials are expected in 2024."

Enrollment status • New P2 trial • P2 data • Immunology • Psoriasis • Psoriatic Arthritis

Harmony-CD: VTX958 for the Treatment of Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P2 | N=132 | Recruiting | Sponsor: Ventyx Biosciences, Inc

New P2 trial • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease

Serenity PsO: VTX958 Versus Placebo for the Treatment of Moderate to Severe Psoriasis (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Ventyx Biosciences, Inc

New P2 trial • Dermatology • Immunology • Psoriasis

Ventyx Biosciences Announces Dosing of the First Patient in the Phase 2 SERENITY Trial of VTX958 for the Treatment of Moderate to Severe Plaque Psoriasis (GlobeNewswire) - "'Dosing of the first patient in the Phase 2 SERENITY trial of VTX958 is a major accomplishment for Ventyx and an important step towards providing a new treatment option for patients suffering from moderate to severe plaque psoriasis who are in need of more effective oral therapies,' said Dr. William Sandborn..."

Media quote

Ventyx Biosciences Announces Dosing of the First Patient in the Phase 2 SERENITY Trial of VTX958 for the Treatment of Moderate to Severe Plaque Psoriasis (GlobeNewswire) - "Ventyx Biosciences, Inc...announced that the first patient has been dosed in a Phase 2 trial of its selective, allosteric TYK2 inhibitor VTX958 for the treatment of moderate to severe plaque psoriasis....The Phase 2 SERENITY trial is a randomized, double-blind, placebo-controlled, dose-ranging trial to evaluate the safety and efficacy of VTX958 in patients with moderate to severe plaque psoriasis. The trial will enroll approximately 200 patients randomized to one of four VTX958 doses or placebo for a 16-week double-blind treatment period. The primary efficacy endpoint will evaluate the proportion of subjects achieving a 75% reduction in the Psoriasis Area and Severity Index (PASI-75) at week 16. In addition to the SERENITY Phase 2 trial, Ventyx is on track to initiate two additional Phase 2 trials of VTX958 in psoriatic arthritis and Crohn’s disease before the end of the year."

New P2 trial • Trial status • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis

Ventyx Biosciences Reports Third Quarter 2022 Financial Results and Highlights Recent Corporate Progress (GlobeNewswire) - "We plan to initiate Phase 2 trials of VTX958 in psoriasis, Crohn’s disease and psoriatic arthritis this quarter and we have made significant progress in enrollment of our Phase 2 trial of VTX002 in ulcerative colitis....VTX002 (S1P1R Modulator): We continue to make significant progress enrolling patients in our Phase 2 randomized, placebo-controlled trial of VTX002 in patients with moderate-to-severe active ulcerative colitis. We expect to report topline data in 2023."

Enrollment status • New P2 trial • P2 data • Crohn's disease • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis