Eblasakimab Shows Benefit in Atopic Dermatitis Among Dupilumab-Treated Patients

Interim data from a phase 2 study of eblasakimab suggests the agent could provide rapid and clinically meaningful itch relief in dupilumab-experienced patients with atopic dermatitis.

Billed as the first double-blind, placebo-controlled trial conducted in atopic dermatitis patients previously treated with dupilumab, results of the trial indicate the IL-13 receptor α1 antagonist from Aslan Pharmaceuticals could provide significant and sustained reductions in symptoms, with 60% of those in the weekly eblasakimab 400 mg arm achieving at least a 90% reduction in their Eczema Area Severity Index (EASI) score and 66.7% achieving a Validated Investigator Global Assessment (vIGA) score of 0 or 1 after 16 weeks compared to less than 14% of the placebo group, with 20% of patients receiving eblasakimab achieving a 100% reduction EASI score.

“We know that over 60% of dupilumab-treated patients fail to achieve an IGA score of 0 or 1 after 16 weeks1, and, of those patients that do achieve it, still half do not maintain it after the subsequent 36 weeks,” said Carl Firth, PhD, chief executive officer of ASLAN Pharmaceuticals.¹ “The data we have announced today provide compelling evidence that eblasakimab, with its unique mechanism of action, has the potential to be an important new therapy for this emerging patient population.”

Boasting a dozen approvals, including indications for atopic dermatitis in children as young as 6 months old, dupilumab has established itself as a cornerstone in the management of inflammatory disorders. However, as is noted by Aslan Pharmaceuticals in their release announcing interim results from the TREK-DX study, approximately 60% of patients receiving dupilumab for atopic dermatitis fail to achieve IGA response. With this in mind, the TREK-DX study was launched to investigate the efficacy and safety of eblasakimab in patients with moderate-to-severe atopic dermatitis who discontinued therapy with dupilumab for any reason. Of note, in June 2023, Aslan Pharmaceuticals announced positive results from the phase 2b TREK-AD study of eblasakimab in biologic-naive patients with moderate-to-serve atopic dermatitis in July 2023.^1,2,3

The primary outcome of interest for the trial was the percentage change in EASI score from baseline to week 16. The trial also included multiple secondary outcomes of interest, such as proportion of patients achieving a vIGA score of 0 or 1, proportion of patients with a 75% or greater reduction in EASI (EASI-75), proportion of patients achieving EASI-50, proportion of patients achieving EASI-90, and changes in peak pruritus.¹

Analysis of the primary outcome of interest demonstrated use of eblasakimab was associated with a statistically significant difference in rate of EASI score change relative to placebo therapy at week 16 (86.9% vs 51.2%; P =.0059), despite interim analysis not being powered for statistical significance due to the sample size. Analysis of secondary outcomes indicated use of 73.3% of eblasakimab-treated patients achieved EASI-75 compared to just 14.3% of the placebo group (P = .0431).¹

Additionally, results suggested 60.0% of eblasakimab-treated patients achieved EASI-90 relative to 14.3% of the placebo group and 20% of eblasakimab-treated patients EASI-100 compared to 0% of the placebo group. For peak pruritus numerical rating scale (PP-NRS) score, a 58.9% mean reduction was observed fromfor eblasakimab-treated patients relative to a 12.9% reduction for placebo-treated patients (P = .0015).¹

In their release, Aslan Pharmaceuticals called attention to a subgroup analysis of patients with a baseline EASI score of 18 or above, which was an additional inclusion criterion added in October 2023. In this subgroup analysis, which included 15 individuals, use of eblasakimab produced even greater effects on reduction of EASI score, with a mean reduction of 89.2% in EASI score from baseline observed with eblasakimab relative to 45.7% with placebo therapy (P = .0045). Analysis of secondary outcomes of interest for this group revealed a 61.2% mean reduction in PP-NRS score for eblasakimab-treated patients versus a 1.5% increase for placebo (P = .0004).¹

“We look forward to announcing the topline readout from the full dataset of the TREK-DX study at the end of this year, the first and only placebo-controlled study of dupilumab-experienced [atopic dermatitis] patients, and to optimizing the dose regimen for patients in the planned phase 3 studies of eblasakimab,” Firth added.¹

References:

1. ASLAN Pharmaceuticals. Aslan Pharmaceuticals announces positive interim results from phase 2 study of Eblasakimab in dupilumab-experienced atopic dermatitis patients. ASLAN Pharmaceuticals. April 22, 2024. Accessed April 22, 2024. https://ir.aslanpharma.com/news-releases/news-release-details/aslan-pharmaceuticals-announces-positive-interim-results-phase-2.
2. Stewart J. Dupixent (dupilumab) FDA approval history. Drugs.com. January 29, 2024. Accessed April 22, 2024. https://www.drugs.com/history/dupixent.html.
3. ASLAN Pharmaceuticals. Aslan Pharmaceuticals presents new data from phase 2B study of Eblasakimab in atopic dermatitis in late breaker presentation at 32nd European Academy of Dermatology and Venereology Congress. ASLAN Pharmaceuticals. October 13, 2023. Accessed April 22, 2024. https://ir.aslanpharma.com/news-releases/news-release-details/aslan-pharmaceuticals-presents-new-data-phase-2b-study.