Boulder-based Enveda Biosciences has received clearance from the U.S. Food and Drug Administration (FDA) to initiate clinical trials for its drug candidate, ENV-6946, aimed at treating inflammatory bowel disease (IBD). This development marks a significant milestone for the company, which employs machine learning to identify naturally occurring compounds for drug development.
Inflammatory bowel disease affects millions globally, often leading to high rates of treatment failure and loss of response. According to Enveda, many patients endure a continuous cycle of switching therapies, which can result in hospitalizations, dependence on steroids, and increased risk of serious complications, including colorectal cancer and the need for surgeries such as colectomy. The company emphasizes the urgent demand for safer and more effective oral treatment options for these patients.
With this clearance, Enveda now has three candidates in clinical development, including ENV-6946 for IBD, ENV-308 for obesity, and ENV-294 for atopic dermatitis and asthma. Viswa Colluru, CEO of Enveda, highlighted the importance of this trial, stating, “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.” He added that the new treatment aims to deliver the efficacy of multiple biologics in a single, gut-restricted oral pill, offering patients a convenient and effective solution without compromising safety.
Enveda, known formally as Enveda Therapeutics Inc., has seen substantial financial growth in recent years. The company completed a $119 million Series B funding round, followed by a $150 million Series C in 2024, and recently closed a $150 million Series D. These fundraising successes have led the company to achieve unicorn status, with a valuation exceeding $1 billion.
The organization has a workforce of approximately 300 employees, with operations spanning multiple locations, including its Asian headquarters in Hyderabad, India. In North America, Enveda operates from a 60,000-square-foot facility located in Boulder’s Flatiron Park business campus.
As Enveda moves forward with the clinical trials of ENV-6946, the company is poised to make a significant impact in the treatment landscape for inflammatory bowel disease, addressing a critical need for patients and healthcare providers alike.
