BEN-2293 / BenevolentAI - LARVOL DELTA

BenevolentAI Announces Top-Line Phase IIa Results for Its Topical pan-Trk Inhibitor BEN-2293 (1%) in Mild-to-Moderate Atopic Dermatitis (Businesswire) - P1/2a | N=123 | NCT04737304 | Sponsor: BenevolentAI Bio | "BenevolentAI...announces top-line results from its Phase IIa, randomised, double-blind, placebo-controlled study of BEN-2293, a topical pan-Trk inhibitor....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."

P2a data • Atopic Dermatitis • Immunology

BenevolentAI Unaudited Preliminary Results for the Year Ended 31 December 2022 (Businesswire) - "BEN-2293...A topical potentially best-in-class PanTrk inhibitor in development to relieve inflammation and rapidly resolve the itch in patients with atopic dermatitis (AD). Completed a Phase IIa study and expect top-line data by the end of March 2023. BEN-8744...An oral peripherally-restricted small molecule PDE10 inhibitor under development as a first-in-class treatment for ulcerative colitis (UC) and with potential for other indications within inflammatory bowel diseases....expect to initiate a Phase I clinical trial in H1 2023. BEN-28010...An orally administered asset under development as a best-in-class treatment for glioblastoma multiforme (GBM). Declared as a clinical candidate in July 2022, with preparation for IND-enabling studies ongoing. The asset could be ready for Phase I studies in 2024."

New P1 trial • P2a data • Atopic Dermatitis • Glioblastoma • Glioma • Immunology • Inflammation • Inflammatory Bowel Disease • Oncology • Solid Tumor • Ulcerative Colitis

A First-in-Human PoC Study With BEN2293 in Patients With Mild to Moderate Atopic Dermatitis (clinicaltrials.gov) - P1/2 | N=123 | Completed | Sponsor: BenevolentAI Bio | Recruiting ➔ Completed

Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

What's New in Topicals for Atopic Dermatitis? (PubMed, Am J Clin Dermatol) - "First-line therapy for acute management of AD includes topical therapies such as corticosteroids, calcineurin inhibitors, and, more recently, the phosphodiesterase inhibitor crisaborole...This review summarizes selected therapeutic topical agents in later phases of development that target various aspects in the pathogenesis of AD such as Janus kinase inhibition (ruxolitinib and delgocitinib), phosphodiesterase-4 inhibition (roflumilast and difamilast), aryl hydrocarbon modulation (tapinarof), and modulation of the microbiome. We also review novel targeted therapies that are in early phase clinical trials, including AMTX-100, BEN-2293, and PRN473. Preliminary findings on efficacy and tolerability of most of these agents are promising, but further studies are warranted to evaluate the long-term safety and efficacy of these novel agents against the current standard of care."

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A First-in-Human PoC Study With BEN2293 in Patients With Mild to Moderate Atopic Dermatitis (clinicaltrials.gov) - P1/2 | N=130 | Recruiting | Sponsor: BenevolentAI Bio | Trial completion date: Apr 2022 ➔ Dec 2022 | Trial primary completion date: Mar 2022 ➔ Dec 2022

Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A First-in-Human PoC Study With BEN2293 in Patients With Mild to Moderate Atopic Dermatitis (clinicaltrials.gov) - P1/2; N=130; Recruiting; Sponsor: BenevolentAI Bio

Clinical • New P1/2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology