Mixed results from latest study of BenevolentAI's dermatitis ointment
BenevolentAI has been trialling its topical pan-Trk inhibitor BEN-2293 (1%) and the most recent results show that it successfully met its primary endpoint and found to be safe and well-tolerated. However, secondary efficacy endpoints to reduce itch and inflammation were not achieved.
The company said that 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 greater than 20% over time, suggesting potential for further clinical investigation.
BenevolentAI 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.
The phase 2a study looked at 91 patients aged between 18-65 years with mild-to-moderate AD were randomised to receive either 1% BEN-2293 given to 49 patients or placebo given to the remaining 42. It was applied twice daily for 28 days on affected skin up to a maximum of 30% body surface area.
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 population.
However, initial analysis of percentage body surface area 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.
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.
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.”
Atopic dermatitis is the most common chronic inflammatory skin disease, characterised by intensely itchy, red and swollen skin.
The company says there is an unmet need for treatments that address itch and inflammation in mild to moderate patients, with fewer side effects than steroid creams and various inhibitor treatments that are currently the dominant forms of treatment.