Leo Pharma recently announced that its anti-interleukin-13 (IL-13) biologic therapy met all its primary and secondary endpoints across three pivotal Phase III studies as part of the company’s ECZTRA trial series.
The drug is in development for the treatment of moderate-to-severe atopic dermatitis, tralokinumab. The announcement came on 11 December 2019.
LEO Pharma is likely to file for approval in 2020, and tralokinumab is expected to be the first biologic treatment in the atopic dermatitis space to challenge Sanofi and Regeneron’s Dupixent (dupilumab), which quickly solidified its place as the gold standard of therapy since its approval in the US in 2017.
Over the next decade, GlobalData anticipates that Dupixent will remain the most prescribed atopic dermatitis biologic, with global 2027 sales of $5.3bn, but will see noticeable competition from tralokinumab, which is expected to generate global 2027 sales of $1.6bn.
Although no study results have been published yet, tralokinumab demonstrated significant efficacy compared to placebo in Phase IIb trials with 42.5% of patients in the 300mg dose patient arm achieving a minimum improvement of 75% in the Eczema Area and Severity Index (EASI75), compared to 15.5% of patients in the placebo group.
Across the Phase III ECZTRA 1, ECZTRA 2, and ECZTRA 3 studies, a total of 2210 participants were enrolled in randomised, double-blinded trials testing the efficacy and safety of tralokinumab against placebo.
ECZTRA 3 also tested the efficacy and safety of the drug in combination with topical corticosteroids (TCS) to replicate the treatment regimen that moderate-to-severe atopic dermatitis patients often follow in the clinic.
The primary endpoints for the studies were the proportion of patients achieving an Investigator’s Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) at Week 16, and the proportion of patients achieving EASI75 at Week 16. The secondary endpoints consisted of a proportion of patients achieving improvements across the Scoring Atopic Dermatitis (SCORAD) scale, pruritus Numerical Rating Scale (NRS), and Dermatology Life Quality Index (DLQI).
Each trial lasted for 52 weeks and consisted of six treatment arms:
- Tralokinumab treatment period until Week 16, followed by tralokinumab maintenance regimen A
- Tralokinumab treatment period until Week 16, followed by tralokinumab maintenance regimen B
- Tralokinumab treatment period until Week 16, followed by a placebo maintenance regimen
- Placebo treatment period until Week 16, followed by a placebo maintenance regimen
- Tralokinumab treatment period until Week 16, followed by an open-label tralokinumab maintenance regimen
- Placebo treatment period until Week 16, followed by an open-label tralokinumab maintenance regimen
LEO Pharma’s announcement comes at the end of a busy year for the atopic dermatitis pipeline.
Earlier this year, Pfizer shared positive results from two Phase III studies for its first-in-class Janus kinase (JAK) inhibitor abrocitinib, and Dermira announced that it had been granted Fast Track designation by the Food and Drug Administration (FDA) due to positive data from its Phase IIb trial.
Phase III trials for lebrikizumab have begun, posing a challenge to LEO Pharma’s tralokinumab as they are both anti-IL-13 biologics. However, because lebrikizumab is set to enter the atopic dermatitis space after tralokinumab, GlobalData expects that lebrikizumab will only earn global 2027 sales of $617m. With such a dynamic late-stage pipeline, the future of the atopic dermatitis market looks to be very competitive.
GlobalData (2018) Atopic Dermatitis – Market Analysis and Forecasts to 2027, November 2018, GDHC172PIDR