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, 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.”