The future of the atopic dermatitis space is going to be a competitive one. Multiple assets are in line to be submitted for regulatory approval and will, if approved, challenge the leading market share currently held by Regeneron and Sanofi’s Dupixent.
Days after Denmark-based LEO Pharma stepped up with impressive late-stage results in its atopic dermatitis biologic, tralokinumab, analysts have pegged the treatment as a blockbuster drug with the potential to generate $1.6 billion in global sales by 2027. LEO Pharma said tralokinumab, an anti-interleukin-13 (IL-13) biologic for the treatment of moderate-to-sever atopic dermatitis, hit the mark in three Phase III trials by meeting all primary and secondary endpoints. The trial news puts LEO on track to seek regulatory approval with the U.S. Food and Drug Administration, as well as the European Medicines Agency, in the coming year.
Tralokinumab is not expected to become the top-selling drug for atopic dermatitis that will still likely be Dupixent. Over the next 10 years, GlobalData predicts that Dupixent will have $5.3 billion in sales. But, tralokinumab will take a chunk of money from the space with the $1.6 billion in predicted sales by 2027, the data and analytics company said.
The primary endpoints in the three studies were an Investigator Global Assessment score of clear (0) or almost clear (1) skin at week 16 and at least a 75% or greater change from baseline in their Eczema Area and Severity Index (EASI) score at week 16. A change from baseline to week 16 in SCORing of Atopic Dermatitis (SCORAD), Pruritus Numeric Rating Scale (NRS) of at least 4, and Dermatology Life Quality Index (DLQI) were secondary endpoints. While full trial results from the Phase III ECZTRA studies, 1, 2 and 3, were not made public, LEO Pharma said tralokinumab hit the mark in those studies.
“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 2,210 participants were enrolled in randomized, double-blinded trials testing the efficacy and safety of tralokinumab against placebo,” Antoine Grey, a senior immunology analyst at GlobalData said in a statement.
Atopic dermatitis is the most common dermatological disease, affecting over 200 million patients worldwide. Up to one-third of adult atopic dermatitis patients are considered moderate to severe. Kim Kjoeller, head of global R&D at LEO, said despite recent advances in the treatment of atopic dermatitis, there are constant calls for additional treatment options to address the different signs and symptoms for each patient. Atopic dermatitis in its moderate-to-severe form can cause unbearable recurring symptoms for patients, Kjoeller said when the company announced the results.
“We are encouraged by these study results, which show that tralokinumab could be an efficacious and well-tolerated long-term treatment solution for patients living with this debilitating chronic skin disease,” Kjoeller added.
Should it be approved, tralokinumab won’t be the only drug trying to chip away at Dupixent’s hold on the market. This year several companies have made strides in the atopic dermatitis space. Earlier this month, Singapore-based ASLAN Pharmaceuticals announced positive preliminary data from the lowest dose cohort of its ongoing multiple ascending dose (MAD) study of ASLAN004. Like tralokinumab, the ASLAN asset is a monoclonal antibody that binds to the IL-13 receptor α1 subunit (IL-13Rα1), blocking signaling of two pro-inflammatory cytokines, IL-4 and IL-13. Both IL-4 and IL-13 are central to triggering symptoms of atopic dermatitis, such as redness and itching of the skin.
In September, Pfizer’s oral Janus kinase 1 (JAK1) inhibitor, abrocitinib hit the mark in a Phase III trial. Results of that trial showed that by week 12 the percentage of patients achieving each co-primary efficacy endpoint and each key secondary endpoint with either dose of abrocitinib was statistically significantly higher than placebo.
Olumiant (baricitinib), another JAK inhibitor developed by Eli Lilly and Incyte, flexed its muscle in the moderate-to-severe atopic dermatitis space this year as well. The drug hit the mark in multiple Phase III trials this year. The companies said adding baricitinib to standard-of-care topical corticosteroids significantly improved disease severity, measured by the validated Investigator’s Global Assessment for AD score of “clear or almost clear” skin at 16 weeks.
