Lilly’s Taltz meets Phase IV plaque psoriasis trial endpoints

14th August 2019 (Last Updated December 22nd, 2019 15:33)

Eli Lilly has reported that the Phase IV IXORA-R clinical trial of Taltz (ixekizumab) met the primary and key secondary endpoints up to week 12.

Lilly’s Taltz meets Phase IV plaque psoriasis trial endpoints

Eli Lilly has reported that the Phase IV IXORA-R clinical trial of Taltz (ixekizumab) met the primary and key secondary endpoints up to week 12.

The head-to-head study assessed Taltz’s safety and efficacy in treating moderate to severe plaque psoriasis when compared to Janssen Biotech’s Tremfya (guselkumab).

Taltz is a monoclonal antibody designed to specifically bind with interleukin 17A (IL-17A) cytokine and block its interaction with the IL-17 receptor, while Tremfya is an IL-23/p19 inhibitor.

A total of 1,027 patients who participated in the trial received either Taltz or Tremfya over 24 weeks.

Preliminary data at week 12 showed that the primary endpoint was met, with Taltz showing superiority in the proportion of patients who experienced complete skin clearance as measured using the Psoriasis Area Severity Index (PASI).

Lilly’s drug also met all key secondary endpoints up to week 12, demonstrating superiority in PASI 75 at week two and PASI 90 / PASI 100 at weeks four and eight.

The drug also showed superiority in the proportion of patients with static Physician’s Global Assessment (sPGA) zero at week 12 and PASI 50 at week one.

Taltz’s safety profile was also observed to be consistent with previous data and no new safety signals were identified.

Eli Lilly immunology development vice-president Lotus Mallbris said: “We’re pleased to see that Taltz helped more people achieve 100% skin clearance compared to Tremfya at week 12. These positive results reinforce that Taltz is an important treatment option for people with this disease.”

The company intends to share data on the remaining major secondary endpoint of PASI 100 at 24 weeks in 2020.

Taltz currently holds approvals for treating adults with moderate to severe plaque psoriasis who are eligible to receive systemic therapy or phototherapy, and those with active psoriatic arthritis.