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.
Eli Lilly's Omvoh receives US FDA approval
Incyte and Syndax receive US FDA approval for Niktimvo (axatilimab-csfr) in 9 mg and 22 mg vials
Sen-Jam Pharmaceutical receives ethics approval for Australian clinical trial of SJP-001
PacBio and Intus Bio launch GutID, first at-home microbiome test powered by HiFi sequencing
Veralox Therapeutics agrees Nudge Therapeutics acquisition
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