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2024-04-12T12:02:01.000Z

Safety of enpatoran in patients with active SLE/CLE: results from a phase Ib study

Apr 12, 2024
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Learning objective: After reading this article, learners will be able to cite a new clinical development in systemic lupus erythematosus.
Enpatoran is a potent and highly selective toll-like receptor 7/8 inhibitor, with glucocorticoid-sparing potential. It was shown to suppress disease activity in systemic lupus erythematosus (SLE) mouse models and exhibited good tolerability among healthy participants and patients with COVID-19 pneumonia. 

At the 14th European Lupus Meeting, Roy.1 presented safety findings from an ongoing phase Ib study of enpatoran by Wenzel et al.2 in patients with active SLE or cutaneous lupus erythematosus (CLE).1,2 Here, we summarize the key points. 

Study design 

  • This is a randomized, placebo-controlled, double-blind, dose-ascending trial (NCT04647708), exploring the maximal anticipated therapeutic range of oral enpatoran vs placebo in patients with active SLE/CLE (Figure 1).1,2 

Figure 1. Study design* 

CLASI, Cutaneous Lupus Erythematosus Disease Area and Severity Index; CLE, cutaneous lupus erythematosus; BID, twice-daily; SFU, safety follow-up; SLE, systemic lupus erythematosus; SLEDAI-2K, Systemic Lupus Erythematosus Disease Activity Index 2000 

*Adapted from Roy.1 
Cohort 4 was optional and was not activated.

  • This analysis was based on blinded data with a cut-off date of Aug 10, 2023.2 

Key findings1,2 

  • Out of 25 randomized patients, 20 completed treatment. 

    • Two patients were undergoing treatment, while three had discontinued treatment due to reasons unrelated to safety. 

  • Overall, 12 patients reported 1 treatment-emergent adverse event (TEAE; Figure 1). 

    • 93% of TEAEs were mild (n=19) or moderate (n=8) in severity. 

    • One Grade 4 TEAE (laboratory abnormality of decreased lymphocyte count) was reported. 

  • There were no instances of Grade 3 TEAEs, serious TEAEs, dose-limiting toxicities, adverse events of special interest, life-threatening TEAEs, or deaths (Figure 2). 

  • No safety concerns were observed in the electroencephalogram and electroencephalogram findings. 

    • No clinically significant abnormalities were noted in electrocardiogram readings. 

    • All electroencephalogram results were within the normal limits. 

Figure 2. Safety findings*  

AE, adverse event; TEAE, treatment-emergent AE. 
*Data from Roy.1 
Includes severe infections, seizures, serotonin syndrome, and clinically significant cardiac arrhythmias. 

Key learnings

  • As of the cut-off date, the phase Ib clinical trial found no new safety signals with enpatoran in patients with SLE/CLE.
  • A phase II, proof-of-concept study, WILLOW (NCT05162586), is currently underway to evaluate the safety and efficacy of enpatoran in a larger cohort of patients with SLE and/or CLE.

  1. Roy S. Safety evaluation from an ongoing randomized, double-blind, multiple-ascending dose phase Ib study of enpatoran versus placebo in patients with active systemic or cutaneous lupus erythematosus (SLE/CLE). Abstract #P102. 14th European Lupus Meeting; March 21, 2024; Bruges, BE. 
  2. Wenzel J, Abramova N, Weinelt D, et al. Safety evaluation from an ongoing randomized, double-blind, multiple-ascending dose phase Ib study of enpatoran versus placebo in patients with active systemic or cutaneous lupus erythematosus (SLE/CLE). Abstract #P102. Lupus Sci Med. 2024;11(Suppl_1):A1–A185. DOI:10.1136/lupus-2024-el.156 

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