Enveda, a clinical-stage biotechnology company, announced the successful completion of its Phase 1 clinical trial for ENV-294, a novel oral anti-inflammatory therapeutic targeting atopic dermatitis and asthma. The first-in-class small molecule, discovered through the company's AI-driven platform that mines natural chemistry, demonstrated favorable safety and tolerability results that prompted advancement to Phase 1b trials in atopic dermatitis patients.
Phase 1a Safety Results Support Clinical Advancement
The Phase 1a trial was conducted as a randomized, double-blind, placebo-controlled, single and multiple ascending dose study in healthy adult subjects. ENV-294 was well-tolerated with a favorable safety profile across all dose levels, with no dose-limiting toxicities or serious adverse events reported. Pharmacokinetic data demonstrated dose-proportional exposure and support the potential for once-daily oral dosing.
Based on these results, the Safety Review Committee endorsed advancement to a Phase 1b clinical trial evaluating ENV-294 in patients with atopic dermatitis. The Phase 1b trial is designed to evaluate the safety, tolerability, pharmacokinetics, target engagement, and early signs of efficacy of ENV-294 in patients with moderate to severe atopic dermatitis, with initiation expected to begin in the second half of 2025.
Addressing Significant Unmet Medical Need
Atopic dermatitis affects approximately 200 million people worldwide, including about 26 million individuals in the United States. Despite its prevalence, current treatment options often rely on injectables, which can present barriers related to cost, accessibility, and patient adherence, or oral therapies that carry significant safety concerns, including black box warnings of potential organ toxicity and systemic side effects.
"Atopic dermatitis is one of the most common diseases yet still has significant unmet need," said Jonathan Silverberg, MD, PhD, MPH, Professor of Dermatology and Director of Clinical Research and Contact Dermatitis at The George Washington University School of Medicine and Health Sciences, and member of Enveda's Therapeutic Advisory Board. "I'm encouraged that Enveda's ENV-294 is showing such a promising safety profile. An oral, safe, novel mechanism would represent a meaningful development for patients and physicians."
Platform Validation Through Clinical Success
The successful completion of the Phase 1a study for ENV-294 marks a critical milestone for Enveda, strongly validating the company's AI-driven drug discovery platform. With the goal of rapidly translating nature's chemistry into safer and more effective therapies, Enveda's innovative approach significantly accelerates drug development timelines and reduces costs, demonstrating clear advantages over conventional methods.
"Achieving our first clinical safety objective with ENV-294 marks another significant advancement in how we discover and develop novel medicines," said José Trevejo, MD, PhD, Chief Medical Officer and Head of Clinical Pipeline Strategy at Enveda. "By combining AI with nature's untapped chemistry, we're charting a new path that leads to real hope for patients. ENV-294's progress isn't just a potential milestone for atopic dermatitis treatment; it's proof that our platform can deliver innovative medicines where they're needed most."
AI-Driven Natural Chemistry Discovery
Enveda uses AI-powered tools to identify and characterize a wide range of molecules produced by living organisms—the vast majority of which have never been explored by science—creating a database of chemical biodiversity described as the library of life. By growing, organizing, translating, and searching this unique library, Enveda learns from life's evolved solutions to address pressing medical needs.
ENV-294 represents a first-in-class anti-inflammatory small molecule with an innovative breakthrough mechanism and broad therapeutic potential beyond atopic dermatitis, including potential applications in asthma treatment.
