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Trial of Lead Atopic Dermatitis Drug Reports Unsatisfactory Results

Article

Researchers say itch and inflammation markers were not met, and trial results are not conclusive.

A recent phase 2a trial of BEN-2293, a lead drug in atopic dermatitis treatment, reported unsatisfactory efficacy in both itch and inflammation reduction, according to a press release.1 

Dragana Gordic/AdobeStock
Dragana Gordic/AdobeStock

BEN-2293 is a topical tropomyosin-related kinase (Trk) reception inhibitor (PanTrk) and a selective inhibitor of the 3 Trk inhibitors, TrkA, TrkB, and TrkC. The drug is intended to address an unmet need in patients with mild to moderate atopic dermatitis, all the while producing fewer side effects than current treatment options.

In December 2021, BenevolentAI announced phase 1b results from its double-blind, placebo-controlled, first-in-patient study, which assessed the safety and tolerability of the drug in 32 participants.

“Although the Phase Ib part of the study was not powered to assess efficacy, there was a trend towards a clinically meaningful effect in skin treated with BEN-2293 (reduction from baseline in the percentage of body surface area affected),” according to BenevolentAI.

Phase 2a of the study primarily sought to explore the drug’s safety and efficacy in patients with mild to moderate symptoms. The study’s secondary endpoints included overall participant improvements in accordance with the Eczema Area and Severity Index (EASI) and pruritus Numerical Rating Scale (NRS).

Researchers randomized participants (n=91) between the ages of 18 to 65 with mild-to-moderate atopic dermatitis. Participants either joined the 1% BEN-2293 treatment group (n=49) or the placebo group (n=42).

For a duration of 28 days, participants were instructed to apply their assigned treatment on skin affected by atopic dermatitis on a twice-daily basis. This was limited to a maximum body surface area (BSA) of 30%.

By the study’s conclusion, researchers had found BEN-2293 to be both safe and well-tolerated in participants. However, secondary endpoints related to EASI and NRS scoring were not met, with the drug lacking a statistically significant effect on either scale.

"Initial analysis of percentage BSA affected by AD [atopic dermatitis] showed an EASI treatment effect for BEN-2293 in patients with greater extent of disease at baseline, with magnitude of treatment effect growing over time,” the press release said. “This result was also observed in the Per-Protocol population with the data at 28 days showing an interaction between treatment effect and disease burden such that a significant treatment effect for BEN-2293 over placebo is expected for subjects with BSA affected of 20% or greater. This initial analysis suggests a new avenue for further clinical investigation.”

According to the press release, these results are not conclusive.

"BEN-2293 was found to be safe and well tolerated in this study. Although the top-line efficacy findings are not conclusive, the significant relationship of EASI efficacy with affected BSA requires further investigation and supports the hypothesis of utilising a PanTrk inhibitor in AD,” said Anne Phelan, PhD, chief scientific officer at BenevolentAI in the press release. “We will continue to review and analyse the complete dataset in order to fully understand the outcome and the next steps."

Reference

  1. BenevolentAI announces top-line phase IIa results for its topical pan-Trk inhibitor BEN-2293 (1%) in mild-to-moderate atopic dermatitis. News | Business Wire. https://www.businesswire.com/news/home/20230404006090/en/BenevolentAI-Announces-Top-Line-Phase-IIa-Results-for-Its-Topical-pan-Trk-Inhibitor-BEN-2293-1-in-Mild-to-Moderate-Atopic-Dermatitis. Published April 5, 2023. Accessed April 5, 2023.
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