Merck KGaA (Merck) has dosed the first patient in its Phase III clinical programme, ELOWEN-1 and ELOWEN-2, evaluating the oral therapy enpatoran in individuals with lupus who have active skin manifestations.
The randomised, global, placebo-controlled, double-blind trials aim to evaluate enpatoran in this specific patient population.
Enpatoran is designed as a selective oral inhibitor of toll-like receptors 7 and 8 (TLR7/8), intended to modulate immune pathways that are central to lupus-related inflammation.
By acting on these drivers, enpatoran has the potential to impact overall disease activity and address a key mechanism that is not fully managed with existing treatments while preserving broader immune function.
Lupus is a chronic autoimmune disorder that can affect the skin, joints, kidneys, and central nervous system.
Both ELOWEN-1 and ELOWEN-2 are planned to be conducted at 266 sites in 26 countries.
Each trial will enrol around 200 participants, focusing on changes in CLASI-A from baseline as the primary endpoint.
Merck research and development (R&D) global head David Weinreich said: “People living with lupus continue to face significant challenges in achieving disease control and are very often affected by itchy, painful and stigmatised skin manifestations.
“With enpatoran, we aim to target the underlying drivers of lupus and redefine how to approach the disease by understanding both visible skin manifestations and systemic activity.”
ELOWEN principal investigator Professor Eric Morand said: “The ELOWEN programme builds on Phase II findings, where enpatoran demonstrated clinically meaningful improvements in patients with active cutaneous manifestations, regardless of their underlying lupus diagnosis.
"These studies are designed to further explore how targeting shared inflammatory pathways may benefit patients across the lupus spectrum.”
In August 2024, Merck dosed the first subject in a Phase III trial of oral Cladribine to treat generalised myasthenia gravis (gMG), a rare neuromuscular disorder.
