Dive Brief:
- Ventyx Biosciences will stop funding trials of an experimental TYK2 drug after it missed the main goal of a Phase 2 study in people with Crohn’s disease, the company said Monday. Treatment with the oral drug didn’t result in a statistically significant difference in Crohn’s symptoms.
- The drug, code-named VTX958, previously had disappointing data in psoriasis, which prompted Ventyx to cancel research in another autoimmune disorder, psoriatic arthritis. Ventyx will likely shift focus to another experimental drug in its pipeline, a novel medicine that could help spur weight loss in people with obesity.
- The failure of the TYK2 drug was “unsurprising” given its lackluster earlier data, Stifel analyst Alex Thompson wrote. Nonetheless, shares fell by as much as 28% in early trading Monday.
Dive Insight:
Ventyx has aimed to compete with Bristol Myers Squibb’s Sotyktu, the first TYK2 drug approved by the Food and Drug Administration, in psoriasis. The drugs inhibit an enzyme that signals the body to create proteins that promote inflammation. That enzyme is part of a broader family called Janus kinases, or JAKs, that are targeted by such drugs as Pfizer’s Xeljanz and AbbVie’s Rinvoq, although drug developers believe the TYK2 class may be safer for patients’ hearts than the earlier JAK inhibitors.
But Ventyx is up against a larger company in Takeda, which has already pushed its TYK2 drug, obtained for $4 billion through the buyout of Nimbus Therapeutics, into Phase 3 studies. Regulatory filings are targeted for 2026. Among Takeda’s planned trials is a head-to-head trial against Sotyktu.
In the Phase 2 trial of VTX958, 109 people with moderate or severe Crohn’s disease got one of two doses of the drug or a placebo. After 12 weeks, trial volunteers were asked about symptoms on a standardized test. The people who received VTX958 had a similar change in their symptoms scores as those given a placebo, with Ventyx noting a “higher than anticipated placebo response.”
People who received VTX958 had more signs of disease relief than those who got the placebo when examined under an endoscope, a secondary goal of the trial. Ventyx said trial researchers will continue to study the data “to better understand the discordance between symptomatic and endoscopic response data.” However, the company said it does not expect to support further trials “with internal resources,” which suggests it might consider outlicensing VTX958.
Stifel’s Thompson wrote that the ramp down in VTX958 spending will give Ventyx executives a chance to “pivot” to work on VTX3232, a drug that blocks a target called NLRP3 and is being advanced for obesity. The company has said it plans on initiating a Phase 2 trial by the end of the year.