Ventyx Biosciences Inc shares sank as much as 20% in pre-market trading on Tuesday after the clinical-stage biopharmaceutical company announced results from the Phase 2 trial of VTX002, a novel oral S1P1 receptor modulator, in patients with moderate-to-severely active ulcerative colitis (UC).
Ventyx said 28% of patients on the 60 milligram (mg) dose and 24% of patients on the 30 mg dose achieved the primary endpoint of clinical remission at week 13 compared to 11% of patients on placebo.
"The positive Phase 2 data for VTX002 establish a highly attractive profile for an oral agent in moderate-to-severely active UC, with the 60 mg dose achieving a compelling clinical remission rate, an unprecedented rate of complete endoscopic remission, and an excellent safety and tolerability profile," Ventyx Biosciences chief medical officer William Sandborn said in a statement.
The company noted that VTX002 was well tolerated in both dose cohorts, with no treatment-related serious adverse events observed.
The negative initial reaction from investors, though, appears to be related to doubts about whether Ventyx’s drug candidate has an edge over rival S1P1 modulators, such as Pfizer’s etrasimod and Bristol Myers Squibb’s Zeposia.
Bristol Myers Squibb received US Food and Drug Administration (FDA) approval for Zeposia in May 2021, while Pfizer is nearing authorization for etrasimod, which gives both drugmakers a considerable head start over Ventyx in the race for market acceptance and would likely make it more difficult for Ventyx to raise money for a Phase 3 study.
The Phase 2 trial of VTX002 was a 13-week, randomized, double-blind, placebo-controlled, dose-ranging trial evaluating the efficacy and safety of two oral doses of VTX002 (30 mg and 60 mg once daily) in patients with moderate-to-severely active UC.
Contact Sean at sean@proactiveinvestors.com