Enveda Advances Third Asset to the Clinic With US FDA IND Clearance and Phase 1 Initiation of ENV-6946, a First-in-Class Oral “Multi-Biologic in a Pill” for Inflammatory Bowel Disease

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7:00 AM on Tuesday, December 23, 2025

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BOULDER, Colo.--(BUSINESS WIRE)--Dec 23, 2025--

Enveda, a multi-asset 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 the US Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for ENV-6946. Following this clearance, Enveda has initiated a Phase 1 clinical trial for ENV-6946, a first-in-class oral small molecule for the treatment of Inflammatory Bowel Disease (IBD).

This milestone marks Enveda’s third asset to enter clinical development, following ENV-294 (atopic dermatitis and asthma) and ENV-308 (obesity), underscoring the productivity of the company’s platform in delivering novel medicines for large patient populations. IBD affects millions of patients worldwide and is marked by high rates of treatment failure and frequent loss of response. Many patients face a chronic cycle of therapy switching that can lead to hospitalizations, steroid dependence, and progression to colorectal cancer or irreversible surgery such as colectomy. These challenges underscore the urgent need for safer, more durable oral treatment options.

ENV-6946 is designed as a “multi-biologic in a pill,” capable of inhibiting multiple pro-inflammatory cytokine pathways—including TNFα, IL-23, and TL1A—that are currently targeted by separate injectable biologics. By combining these mechanisms into a single, oral small molecule via a first-in-class mechanism and a gut-preferred pharmacokinetic profile, ENV-6946 aims to maximize efficacy at the site of disease while minimizing systemic exposure and associated safety risks.

“The initiation of our Phase 1 trial for ENV-6946 represents a significant achievement for Enveda, as we now have three distinct first-in-class assets in the clinic,” said Viswa Colluru, Ph.D., Chief Executive Officer of Enveda. “ENV-6946 perfectly embodies our mission to translate life’s chemistry into better medicines. By delivering the efficacy of multiple biologics in a single, gut-restricted oral pill, we hope to provide patients with IBD a convenient and potent therapy that does not force a tradeoff between efficacy, convenience, and safety.”

About the Phase 1 Clinical Trial

The Phase 1 clinical trial is a study designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of ENV-6946 in healthy volunteers. The study will assess single-ascending-dose (SAD) regimens with plans to proceed to multiple-ascending-dose (MAD) regimens thereafter to establish the safety profile and identify the optimal dosing strategy for future efficacy studies in patients with Ulcerative Colitis and Crohn’s Disease.

“Current treatments for IBD often fall short—many patients fail to respond or lose response over time,” said Jose Trevejo, M.D., Ph.D., Chief Medical Officer of Enveda. “This ceiling on efficacy and high rate of secondary non-response leave a substantial unmet need. ENV-6946 is designed to address this gap by modulating multiple inflammatory pathways and concentrating its activity in the gut, where it’s needed most. We are excited to bring this promising oral therapy into the clinic, where patients are waiting for new approaches that can potentially offer deeper, more durable relief.”

About ENV-6946

ENV-6946 is a novel, first-in-class, oral small molecule in development for the treatment of Inflammatory Bowel Disease (IBD), including Ulcerative Colitis and Crohn’s Disease. It functions as a “multi-biologic in a pill” by simultaneously inhibiting the signaling of key inflammatory cytokines TNFα, IL-23, and TL1A. Designed to be gut-preferred, ENV-6946 aims to deliver robust local efficacy with limited systemic exposure, potentially offering a superior safety profile compared to systemic corticosteroids and JAK inhibitors. In preclinical studies, ENV-6946 demonstrated superior efficacy to multiple standard-of-care benchmarks in animal models of IBD.

About Enveda

Enveda is a multi-asset clinical-stage 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-6946 and the anticipated milestones for our clinical programs. 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 preclinical data may not predict clinical results, and regulatory review processes. ENV-6946 is an investigational agent and is not approved for use by any regulatory authority. Enveda undertakes no obligation to update these statements.

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KEYWORD: COLORADO UNITED STATES NORTH AMERICA

INDUSTRY KEYWORD: RESEARCH TECHNOLOGY FDA CLINICAL TRIALS HEALTH TECHNOLOGY BIOTECHNOLOGY PHARMACEUTICAL HEALTH SCIENCE ARTIFICIAL INTELLIGENCE

SOURCE: Enveda