Enveda, a biotechnology company utilizing artificial intelligence to discover new medicines from natural sources, has announced that its first drug candidate, ENV-294, has entered Phase I clinical trials after receiving FDA clearance of its Investigational New Drug (IND) application. The novel oral anti-inflammatory agent is being developed for the treatment of atopic dermatitis and other inflammatory conditions.
The Phase I trial commenced in late October, marking a significant milestone for Enveda, achieving clinical entry less than four years after its seed financing. ENV-294 represents a first-in-class medicine derived from a molecule discovered in nature using AI and refined through medicinal chemistry.
Addressing Unmet Needs in Atopic Dermatitis
Atopic dermatitis affects over 10% of the U.S. population, with current treatments often relying on injectables or oral therapies that carry potential toxicities. Enveda believes that ENV-294, with its unique mechanism of action and origin in natural products, can offer a safer and more effective alternative. Preclinical studies have demonstrated robust efficacy and high safety margins for the drug candidate.
Jonathan Silverberg, MD, PHD, MPH, Professor and Director of Clinical Research at George Washington University School of Medicine and Health Sciences, noted the significant unmet need for safe and effective oral treatments for moderate to severe atopic dermatitis, emphasizing the promise of Enveda's approach.
AI-Powered Natural Product Discovery
Enveda's AI platform is designed to unlock the potential of nature's chemistry, of which only a fraction is currently understood. The company has built a searchable library of over 1.5 million natural product compounds, growing exponentially, by combining mass spectrometry with machine-learning algorithms. This approach allows Enveda to identify and develop drug candidates at an accelerated pace, reportedly four times faster than industry averages.
Viswa Colluru, Ph.D., CEO and Founder at Enveda, stated that this achievement underscores the progress made in a short time, creating tremendous opportunity not just for Enveda but for doctors and patients around the world.
Expansion to Asthma Treatment
Building on the potential of ENV-294 to address shared inflammatory pathways, Enveda is also exploring its application in asthma treatment. The company has established an advisory board of pulmonologists and asthma researchers to support this development. Enveda believes ENV-294 has the potential to redefine asthma treatment by targeting key pathways involved in airway inflammation via a non-steroidal, orally delivered therapeutic.
