California-based clinical stage biotechnology company Evommune Inc on Wednesday presented the complete data set from its first-in-human proof-of-concept (POC) trial of EVO756, at the seventh GA²LEN Global Urticaria Forum in Berlin, Germany.
The podium clinical presentation entitled 'EVO756, an oral MRGPRX2 antagonist, is well-tolerated and demonstrates target engagement: Results from a Phase 1 Study', was presented by Sarbjit Saini, M.D., professor of Medicine at Johns Hopkins University in Baltmore, Maryland. The presentation summarised the comprehensive positive results from the POC trial, which included 132 subjects.
The randomised, double-blind, placebo-controlled single and multiple ascending dose (SAD and MAD) study in normal healthy adults assessed the safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered EVO756.
In the trial, EVO756 demonstrated an excellent safety profile, robust efficacy and a pharmacokinetic profile supporting once-daily oral dosing. The data suggest the potential of EVO756 as a first and best-in-class opportunity for patients suffering from broad range of chronic inflammatory diseases, Evommune said.
Based on these results, Evommune has initiated the first of multiple Phase 2 trials.
Xentria announces operational expansion of multiple clinical trials in 2025
Insilico Medicine reports positive results from Phase I ISM5411 studies in Australia and China
Chime Biologics and Mabgeek completes Process Performance Qualification for MG-K10
argenx receives Japanese approval for VYVDURA in chronic inflammatory demyelinating polyneuropathy
Zura Bio announces global Phase 2 TibuSURE trial for systemic sclerosis treatment
Vanda Pharmaceuticals receives Orphan Drug Designation from FDA for VGT-1849A
Hansa Biopharma reports positive Phase 2 imlifidase results
Gilead Sciences secures positive CHMP opinion for seladelpar in PBC treatment
GSK's Submission for Nucala (mepolizumab) in COPD accepted by US FDA