UK-based BenevolentAI announced mixed topline data from its Phase IIa trial investigating BEN-2293 in patients with mild-to-moderate atopic dermatitis (AD). BEN-2293 is a selective inhibitor of the three tropomyosin-related kinases (Trk) receptors (TrkA, TrkB and TrkC), also known as a pan-Trk inhibitor, and is formulated to be administered topically.
The primary endpoint of the study measured the safety and tolerability of BEN-2293, while secondary outcomes looked at the proportion of patients that achieved an improvement in the Eczema Area and Severity Index (EASI) and pruritus Numerical Rating Scale (NRS).
While BEN-2293 was safe, well-tolerated and met the trial’s primary endpoint, it did not show a statistically significant effect on EASI or NRS endpoints across the participants in the treatment arm.
However, the company’s press release noted that the initial analysis of body surface area (BSA) percentages affected by AD showed an EASI treatment effect in patients with a greater extent of disease at baseline, with the treatment effect improving over time. Also, BEN-2293 has the potential to improve disease burden in patients with BSA affected greater than by 20% compared to placebo.
Chief Scientific Officer Dr Anne Phelan said: “Although the topline efficacy findings are not conclusive, the significant relationship of EASI efficacy with affected BSA requires further investigation and supports the hypothesis of utilising a pan-Trk inhibitor in AD. We will continue to review and analyse the complete dataset to fully understand the outcome and the next steps.”
The placebo-controlled trial (NCT04737304) randomised 49 patients into the treatment cohort and 42 patients into the placebo arm. Participants received BEN-2293 twice daily for 28 days on the affected skin up to a maximum of 30% of BSA. BenevolentAI dosed its first patient in February 2021.
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AD is a chronic inflammatory condition and is the most common the of eczema. The prevalence of AD is increasing, affecting 10-30% of children and 2-10% of adults, according to National Institute for Health and Care Excellence.
Yet, many cases go undiagnosed. Last year GlobalData’s epidemiologists found that only 40% of AD cases will be diagnosed by the end of 2022 in the seven major pharmaceutical markets (the US, France, Germany, Italy, Spain, UK and Japan). The US was expected to experience the highest number of undiagnosed cases.
The epidemiologists identified the need for more timely and accurate diagnosis of AD cases in the primary care setting and prioritisation of addressing gaps in physician awareness and diagnostic criteria. Additionally, educational programmes targeting both patients and physicians can increase AD awareness, diagnosis, assessment of severity, and disease management.