OVERLAND PARK, Kan.– Dr. Vince Clinical Research (DVCR), a full-service contract research organization specializing in early-phase and multi-site clinical trials, announced today that the first patient has been dosed in a Phase 1b study of ENV-294, Enveda Biosciences’ first-in-class anti-inflammatory drug candidate for moderate to severe atopic dermatitis.
ENV-294 is a novel small molecule developed using Enveda’s proprietary drug discovery platform. Designed to treat atopic dermatitis and other chronic inflammatory diseases through a differentiated mechanism, ENV-294 aims to provide new options for patients who require systemic therapies but do not respond well to or tolerate existing treatments.
“DVCR has been an exceptional partner in supporting the advancement of our investigational drug, ENV-294, into the clinic,” said José Trevejo, M.D., Ph.D., Chief Medical Officer and Head of Clinical Pipeline Strategy at Enveda. “Their deep operational expertise and collaborative approach were instrumental in the successful completion of our first-in-human study. We look forward to continuing this productive relationship as we progress through early clinical development.”
The Phase 1b study builds on results from a Phase 1a trial conducted by DVCR, which was a randomized, double-blind, placebo-controlled study evaluating single and multiple ascending doses in healthy adults. In that study, ENV-294 was well tolerated at all dose levels, with no dose-limiting toxicities or serious adverse events, and demonstrated a favorable safety, tolerability, and pharmacokinetic profile. The ongoing multi-site Phase 1b trial will assess safety, tolerability, pharmacodynamics, target engagement, and preliminary efficacy in patients with moderate to severe atopic dermatitis.
“This important milestone—dosing the first subject with atopic dermatitis in the Phase 1b study—is a true testament to the scientific expertise and transformative work of the Enveda team,” said Dr. Brad Vince, CEO and Chief Medical Officer of DVCR. “We are honored that Enveda selected DVCR as a preferred partner for this important program.”
According to the National Eczema Association, atopic dermatitis affects more than 26 million Americans and an estimated 200 million people worldwide. The chronic, relapsing condition is characterized by inflammation, itch, skin pain, and reduced quality of life.
