BenevolentAI announces top-line Phase IIa results for its topical pan-Trk inhibitor BEN-2293 (1%) in mild-to-moderate atopic dermatitis

BenevolentAI announces top-line Phase IIa results for its topical pan-Trk inhibitor BEN-2293 (1%) in mild-to-moderate atopic dermatitis

• Successfully met primary endpoint with BEN-2293 found to be safe and well tolerated
• Secondary efficacy endpoints, to reduce itch and inflammation, were not achieved. However, initial analyses in the Per-Protocol population have shown a statistically significant treatment effect in Eczema Area and Severity Index (EASI) change from baseline for patients with an Atopic Dermatitis affected percentage body surface area (BSA) greater than 20% over time, suggesting potential for further clinical investigation
• The Company is conducting a review of the full dataset to help guide further development for BEN-2293 and it will report the full results at a later date, as warranted

London, UK, 5 April 2023: BenevolentAI ("BenevolentAI" or the "Company") (Euronext Amsterdam: BAI) announces top-line results from its Phase IIa, randomised, double-blind, placebo-controlled study of BEN-2293, a topical pan-Trk inhibitor. BEN-2293 is a selective inhibitor of the three tropomyosin-related kinases (Trk) receptors (TrkA, TrkB and TrkC) formulated to be administered topically in patients with mild-to-moderate AD.

The study's primary endpoint was safety and tolerability, while secondary endpoints of the study were also specifically powered to show the fraction of patients achieving an improvement in the Eczema Area and Severity Index (EASI) and the fraction of patients achieving an improvement in the pruritus Numerical Rating Scale (NRS).

In this Phase IIa study, 91 patients aged between 18-65 years with mild-to-moderate AD were randomised to receive either 1% BEN-2293 (n=49) or placebo (n=42) twice daily for 28 days on affected skin up to a maximum of 30% body surface area (BSA). BEN-2293 was shown to be safe and well-tolerated but did not demonstrate a statistically significant effect on NRS or EASI endpoints across the Intention-To-Treat (ITT) population.

However, initial analysis of percentage BSA affected by AD 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 (p=0.0296). This result was also observed in the Per-Protocol population (p=0.0427) with the data at 28 days showing an interaction between treatment effect and disease burden (p=0.0237) 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. 

Dr Anne Phelan, Chief Scientific Officer at BenevolentAI, said: "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. We will continue to review and analyse the complete dataset in order to fully understand the outcome and the next steps.”

Enquiries:

Investors:

Fleur Wood – VP Investor Relations

fleur.wood@benevolent.ai

investors@benevolent.ai

T: +44(0) 203 781 9360

Media:

Rajin Kang - VP Communications

rajin.kang@benevolent.ai

T: +44(0) 203 781 9360