LEO Pharma announced that tralokinumab met all primary and secondary endpoints in ECZTRA 1-3, its three pivotal phase 3 studies for moderate to severe atopic dermatitis in adults.
“AD is the most common inflammatory skin disease in the world with limited effective treatment options, especially for moderate to severe patients. We are encouraged that tralokinumab could potentially offer a new long-term treatment for the moderate to severe patient with AD,” Catherine Mazzacco, CEO at LEO Pharma, told Healio in an interview.
Tralokinumab is an investigational, fully human monoclonal antibody that neutralizes the interleukin-13 (IL-13) cytokine, according to a company press release.
“When we look into the pathways involved in this disease, the current thinking today is that the IL-13 plays a pivotal role in the disease of AD,” said Kim Kjoeller, executive vice president, global research and development at LEO Pharma. “Consequently, we are very excited about tralokinumab being the first one that specifically targets this cytokine. When we look at the stronghold of the clinical data, meeting all primary and secondary endpoints in all phase 3 clinical trials, that makes us really excited here at LEO Pharma.”
The ECZTRA studies assessed tralokinumab as monotherapy in adults with moderate to severe AD who are candidates for systemic therapy. The randomized, double-blind, placebo-controlled, multinational 52-week studies included 802 adults in ECZTRA 1 and 794 adults in ECZTRA 2.
ECZTRA 3 is a randomized, double-blind, placebo-controlled, multinational 32-week study of 380 adults to evaluate tralokinumab in combination with topical corticosteroids for patients with AD who are candidates for systemic therapy.
The primary endpoints, which were achieved in the three studies, were an Investigator Global Assessment (IGA) score of clear (0) or almost clear (1) at week 16 and at least a 75% or greater change from baseline in Eczema Area and Severity Index (EASI) score at week 16. The secondary endpoints achieved were a change in baseline to week 16 in Scoring of Atopic Dermatitis (SCORAD), Pruritus Numeric Rating Scale of at least 4 and Dermatology Life Quality Index.
LEO Pharma will submit detailed results of the studies for presentation at scientific congresses and peer-reviewed publications in the near future.
“We are preparing for regulatory submission and we anticipate that during 2020 we will submit in all major global geographies,” Kjoeller said. “As [Mazzacco] mentioned, where we see this therapy really being important for the future, is when we look to the current opportunities in the moderate to severe state, we come from a past that has been mostly immunosuppression, which has its drawbacks. To provide a good treatment that is also tolerated for long-term usage, an effective long-term treatment — that is the potential we are trying to unleash here.” – by Abigail Sutton
Disclosures: Kjoeller and Mazzacco are employed by LEO Pharma.