BOULDER, Colo. — Enveda said the U.S. Food and Drug Administration has cleared its investigational new drug application for ENV-6946, allowing the company to initiate a Phase 1 clinical trial of the oral therapy for the treatment of inflammatory bowel disease.
The clearance marks Enveda’s third asset to enter clinical development, following ENV-294 for atopic dermatitis and asthma and ENV-308 for obesity. The company said the milestone further validates its platform’s ability to generate first-in-class small-molecule medicines for high-value indications.
The Phase 1 study will evaluate the safety, tolerability, and pharmacokinetics of ENV-6946 in healthy volunteers. The company described ENV-6946 as a first-in-class oral therapy designed to inhibit multiple inflammatory cytokine pathways simultaneously, including TNFα, IL-23, and TL1A, which are currently targeted by separate injectable biologic drugs.
Inflammatory bowel disease affects millions of patients worldwide and is often associated with high rates of treatment failure and loss of response. Many patients cycle through multiple therapies, which can lead to repeated hospitalizations, steroid dependence, and disease progression requiring major surgical interventions. Enveda said these challenges highlight the need for safer and more durable oral treatment options.
ENV-6946 is designed as what the company describes as a “multi-biologic in a pill,” combining the activity of multiple biologic pathways into a single oral small molecule. The drug is engineered with a gut-preferred pharmacokinetic profile intended to concentrate activity at the site of disease while limiting systemic exposure and reducing the risk of adverse effects.
“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 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 aim to provide patients with inflammatory bowel disease a potent and convenient therapy without forcing tradeoffs between efficacy, convenience, and safety.”
Enveda said it plans to continue advancing its clinical pipeline while applying its discovery platform to additional therapeutic areas with significant unmet medical need.
