Enveda, a biotechnology company using AI to translate nature into new medicines, announced today that the U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for its first asset targeting atopic dermatitis and other inflammatory conditions. The company also announced it has entered this candidate, named ENV-294, into a Phase I clinical trial, with the first patient dosed at the end of October.The novel oral first-in-class anti-inflammatory agent has demonstrated robust efficacy and high safety margins in preclinical studies, and is the first drug candidate to advance to clinical trials based off of a molecule discovered in nature using AI and adapted with modern medicinal chemistry. The achievement marks a significant milestone for Enveda, delivering its first candidate to the clinic in less than four years after announcing its seed financing.
I witnessed the profound impact a new therapeutic can have on a patient, and their family, during my mom’s battle with cancer, and I founded Enveda to provide that life-saving power—and hope—to as many people as possible with whatever condition they may be dealing with,” said Viswa Colluru, Ph.D., CEO and Founder at Enveda. “Today’s achievement underscores the progress we’ve made in such a short time, creating tremendous opportunity not just for Enveda but for doctors and patients around the world. We look forward to building on this momentum to bring relief to those suffering from eczema, other inflammatory conditions, and beyond as our pipeline matures.”
Creating superior treatments by uniting AI + molecules derived from nature
Over 10% (30M+) of the US population suffers from atopic dermatitis according to the National Eczema Association. Yet, today’s treatments for eczema either rely on injectables that pose a significant barrier to patient care and adoption or oral therapies that come with significant potential toxicities. Enveda believes that first-in-class molecules like ENV-294, derived from diverse and biologically relevant chemistry honed by billions of years of evolution, can provide a better alternative.
Natural Products (NPs) and the molecules derived from them (NP-hybrids) have statistically higher chances of clinical success compared to synthetic small molecule therapies; with the proportion of NP and NP-hybrid compounds increasing in later clinical trials stages, contrasted with a decline in the proportion of synthetic compounds.
Atopic dermatitis is a highly burdensome disease. Despite great progress over the last decade with respect to novel treatments there remain multiple unmet needs for safe and effective oral treatments to treat patients with moderate to severe AD. Enveda’s novel approach using a naturally derived drug molecule holds great promise for the treatment of AD,” said Jonathan Silverberg, MD, PHD, MPH Professor and Director of Clinical Research, George Washington University School of Medicine and Health Sciences.
Just 0.1% of nature’s chemistry is understood, yet nearly 50% of all medicines taken in oral form are derived from nature. Enveda’s AI platform uncovers the remaining 99.9% of unknown chemistry in nature and matches those to treat human disease. The company has developed the world’s largest searchable library of natural products of more than 1.5M compounds, and growing exponentially, by combining mass spectrometry with machine-learning algorithms to speed discovery from a process that must be done one molecule at a time to 10,000 molecules at a time. By harnessing this unique and powerful chemistry at scale, Enveda turns prioritized platform hits into Development Candidates 4X faster than industry averages.
