Enveda Initiates Phase 2 Clinical Trials of ENV-294, a First-in-Class Oral Therapy in Atopic Dermatitis and Asthma

Advancement to Phase 2 follows positive interim Phase 1b data in Atopic Dermatitis, demonstrating a robust efficacy and safety profile

Parallel Phase 2a initiated studies evaluating ENV-294, a first-in-class oral small molecule, in two distinct inflammatory indications

Parallel development strategy designed to accelerate assessment of ENV-294’s broad “pipeline-in-a-product” potential

Company planning initiation of Phase 2b dose-ranging study in 2026

BOULDER, Colo.--(BUSINESS WIRE)--Enveda, a clinical-stage biotech company pioneering the discovery and development of a new generation of small-molecule drugs derived from life’s chemistry, today announced that it has initiated two parallel Phase 2a clinical trials evaluating ENV-294, a first-in-class oral small molecule, for the treatment of moderate-to-severe Atopic Dermatitis (AD) and Asthma.

"The initiation of these Phase 2a trials is a major step in our strategy to unlock the full potential of ENV-294. With millions of patients still burdened by injectable biologics, there is a profound opportunity for an oral therapy that does not compromise on safety in AD,” said Viswa Colluru, Ph.D., Chief Executive Officer of Enveda.

“Building on the robust efficacy and safety profile from our analysis of the Phase 1b study in moderate-to-severe AD, we are moving with speed to evaluate ENV-294 in both skin and respiratory conditions simultaneously, accelerating our path to late-stage development," said Jose Trevejo, M.D., Ph.D., Chief Medical Officer of Enveda.

Phase 1b Interim Analysis

In the interim analysis, ENV-294 demonstrated a rapid onset of action, with robust EASI improvements consistent with an anticipated JAK-inhibitor-like efficacy profile in patients with moderate-to-severe AD. Importantly, ENV-294 also maintained the expected biologic-like favorable safety profile consistent with earlier Phase 1a healthy volunteer studies and 3-month GLP toxicology studies.

About the Phase 2a Clinical Trials

The Phase 2a program is designed to evaluate the safety, tolerability, and efficacy of ENV-294 in two distinct patient populations, supporting the Company’s strategy to develop ENV-294 as a “pipeline-in-a-product” for inflammatory diseases.

• Atopic Dermatitis (AD): A randomized, double-blind, placebo-controlled study will evaluate ENV-294 in patients with moderate-to-severe AD. The study aims to characterize the efficacy of ENV-294 across key endpoints, including the Eczema Area and Severity Index (EASI) and Investigator’s Global Assessment (vIGA), as well as other endpoints, while further establishing its safety profile over a longer treatment duration.
• Asthma: A randomized, double-blind, placebo-controlled study has been initiated to evaluate ENV-294 in patients with moderate-to-severe asthma. This study will assess improvements in pulmonary function and safety, marking the first clinical evaluation of ENV-294 in a respiratory indication.

Phase 2b initiation in 2026

Based on the strength of the interim data in AD and the rapid enrollment anticipated for these studies, Enveda plans to initiate a Phase 2b study in 2026.

About ENV-294

ENV-294 is a novel, first-in-class, small molecule discovered using Enveda's proprietary platform for the treatment of multiple inflammatory conditions. It targets a novel non-kinase inflammatory pathway distinct from current advanced therapies like JAK-STAT or cytokine signaling, aiming to deliver an oral agent with high efficacy and favorable safety.

About Enveda

Enveda is a biotechnology company that learns from life’s chemistry to create better medicines faster. 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: the library of life. By growing, organizing, translating, and searching this unique library, Enveda learns from life’s evolved solutions to address today’s most pressing medical needs. For more information, visit enveda.com.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the potential therapeutic benefits of ENV-294 and the anticipated initiation of Phase 2b studies in 2026. These statements are based on management’s current expectations and are subject to substantial risks and uncertainties that could cause actual results to differ materially. These risks include the inherent uncertainties of clinical development, the risk that Phase 1b data may not predict Phase 2 results, and regulatory review processes. ENV-294 is an investigational agent and is not approved for use by any regulatory authority. Enveda undertakes no obligation to update these statements.