In a phase 2 experiment, the Crohn’s disease medication developed by Ventyx Biosciences did not help patients achieve remission.
A total of 109 patients with moderately to highly active Crohn’s disease were participating in the mid-stage trial, in which the company was investigating the allosteric TYK2 inhibitor VTX958. After receiving either one of two dosages of the medication or a placebo for 12 weeks, patients were then subjected to a long-term follow-up. At the beginning of the experiment, the researchers were looking for an improvement in the Crohn’s disease activity index, a typical rating scale that measures the extent of the inflammatory illness. This change was monitored from baseline to week 12.
Ventyx attributed the failure of the study to achieve the primary aim to a placebo reaction being far higher than anticipated.
In light of this, Ventyx has decided not to carry out any further testing of VTX958 using internal resources, as stated in the announcement.
VTX958 did, however, result in a dose-dependent impact on the main secondary objective of endoscopic response, which the firm has stated is both an objective endpoint and a high-priority therapeutic aim. Additionally, a reduction in two important inflammatory markers was observed in both dosage studies.
The company plans to carry out an additional examination of the data to determine the reason for the significant disparity between the endoscopic and symptomatic results.
After a mid-stage trial for individuals with psoriasis in November 2023 revealed mixed findings across the dosage groups, this is the most recent VTX958-related issue for Ventyx. The firm stated that “the magnitude of efficacy observed did not meet our internal target to support advancement of VTX958 in plaque psoriasis.”
The company decided to halt research and development on that indication as well as psoriatic arthritis. Instead, it shifted its efforts to the Crohn’s disease study, which was still accepting participants at the time. As a result of the psoriasis failure, Ventyx’s stock price dropped by 73% to $3.77.
In response, Ventyx laid off 20% of its workforce one month later. Raju Mohan, Ph.D., the CEO of the company at the time, referred to the indication as a considerably larger possibility.
Following the withdrawal of VTX958, Ventyx is now working on three more medications, one of which is VTX002, intended to treat ulcerative colitis. Having already finished a phase 2 test, the company said in May that it would be looking for partners to participate in the late-stage development of the product.
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