Bristol Myers Squibb (BMS) has reported that its drug, deucravacitinib, failed to meet the primary and secondary efficacy goals of the Phase II LATTICE-UC clinical trial in moderate to severe ulcerative colitis (UC) patients.
An oral, selective tyrosine kinase 2 (TYK2) inhibitor, deucravacitinib possesses a peculiar mechanism of action.
It specifically acts on TYK2, to hinder interleukin (IL)-23, IL-12 and Type 1 interferon (IFN) signalling.
These are the main cytokines linked to the pathogenesis of various immune-mediated diseases.
The randomised, placebo-controlled, multicentre Phase II trial analysed the safety and efficacy of deucravacitinib in moderate to severe UC patients.
Clinical remission as assessed using the updated Mayo score at week 12 was the trial’s primary goal.
The secondary goals of the trial comprised clinical response evaluated using the modified Mayo score, endoscopic response and histological improvement at week 12.
Findings showed that the safety profile of deucravacitinib was in line with already reported trials in psoriasis and psoriatic arthritis.
Furthermore, no new safety signals linked to the treatment were reported in the trial.
Bristol Myers Squibb chief medical officer Samit Hirawat said: “Deucravacitinib has been shown to be a highly effective, first-in-class, oral, selective TYK2 inhibitor in psoriasis and we have ongoing Phase III trials exploring the potential of deucravacitinib in psoriatic arthritis.
“While we did not achieve proof of concept in this study, we are committed to advancing our deucravacitinib clinical programme in inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, as well as in psoriatic arthritis, lupus and other immune-mediated diseases.”
The company will conduct a complete review of the LATTICE-UC data.
BMS is currently analysing an increased dose of deucravacitinib for UC in another Phase II IM011-127 trial.
This randomised, placebo-controlled, multicenter study will evaluate the safety, efficacy and biomarker response of the drug in moderate to severe US participants.
Clinical response and safety and tolerability at week 12 are the primary goals of the trial.
Last month, BMS reported positive three-year data from the CheckMate -743 clinical trial where first-line therapy with Opdivo (nivolumab) plus Yervoy (ipilimumab) offered a lasting survival benefit in unresectable malignant pleural mesothelioma patients, irrespective of histology.