Sun Pharma announced late-breaking data from two Phase 3 clinical trials where tildrakizumab met the primary endpoint in patients with moderate-to-severe plaque psoriasis. The findings were presented at the 25th European Academy of Dermatology and Venereology (EADV) Congress.
The reSURFACE 1 and 2 trials were randomized, placebo-controlled, multicenter studies designed to demonstrate the efficacy of tildrakizumab in moderate-to-severe plaque psoriasis vs. placebo and comparative drug, and to assess safety and tolerability. The co-primary efficacy endpoint of the 2 studies were Psoriasis Area Sensitivity Index 75 (PASI 75) response at Week 12 vs. placebo and the proportion of patients with Physician’s Global Assessment (PGA) score of “clear” or “minimal” with ≥2 grade reduction from baseline at Week 12 vs. placebo. The reSURFACE 2 trial also included an etanercept comparator arm.
In the trials, an average of 63% of patients achieved 75% skin clearance (PASI 75) by Week 12 after 2 injections, and 77% of patients achieved PASI 75 after 28 weeks and 3 injections of tildrakizumab 100mg dose. An average of 57% of patients at Week 12 and 66% of patients at Week 28 had a PGA score of “clear” or “minimal” with the tildrakizumab 100mg dose.
An average of 64% of patients who received the 200mg dose experienced PASI 75 at Week 12, and 78% of patients at Week 28. Also, 59% of patients had a PGA score of “clear” or “minimal” at Week 12 and 69% of patients at Week 28.
Tildrakizumab is an investigational humanized, anti-interleukin (IL)-23p19 monoclonal antibody designed to selectively inhibit IL-23. This precise targeting allows tildrakizumab to help control the pathogenic cells responsible for the inflammatory process of psoriasis with minimal impact on the rest of the immune system.
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