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 harnesses machine learning to identify naturally occurring drug compounds.
IBD affects millions globally and is characterized by high treatment failure rates and frequent loss of therapeutic response. According to Enveda, many patients experience a chronic cycle of therapy changes that can lead to hospitalizations, dependence on steroids, and the potential for serious complications such as colorectal cancer or the need for surgical procedures like colectomy. These challenges highlight a pressing need for safer and more effective oral treatment options.
Viswa Colluru, CEO of Enveda, expressed enthusiasm about the 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.” Colluru emphasized the company’s mission to translate life’s chemistry into better medicines, aiming to combine the efficacy of multiple biologics into a single, gut-targeted oral pill. This innovation seeks to provide IBD patients with a convenient and effective treatment without compromising on efficacy, safety, or convenience.
Enveda Biosciences, also known as Enveda Therapeutics Inc., has a robust pipeline with approximately a dozen drug candidates. Besides ENV-6946 for IBD, the company is advancing ENV-308 for obesity and ENV-294 for atopic dermatitis and asthma.
The company has experienced significant financial growth, recently concluding a $119 million Series B funding round, followed by a $150 million Series C in 2024 and a $150 million Series D last year. This series of successful fundraising efforts has positioned Enveda as a unicorn, attaining a valuation exceeding $1 billion.
With around 300 employees globally, Enveda operates from a 60,000-square-foot facility located in Boulder’s Flatiron Park business campus. The company also has a presence in Asia, with its headquarters situated in Hyderabad, India.
As Enveda Biosciences embarks on this clinical trial, the potential impact on IBD treatment could be significant, providing hope for patients seeking more reliable therapies.