Atopic Dermatitis First, Now Onto Asthma for Enveda's Oral Small Molecule Anti-inflammatory Candidate
The investigational molecule with “JAK-inhibitor-like efficacy and IL4/IL13-like safety,” was cleared in Q4 2024 by the FDA for an IND application, the company said.
ENV-294, an investigational oral small molecule with “JAK-inhibitor-like efficacy and IL4/IL13-like safety” now in phase 1 studies for atopic dermatitis, will be tested in asthma, a second indication in which the drug could potentially address the shared pathways underlying multiple inflammatory conditions, according to developer Enveda.1
Courtesy of enveda
The FDA cleared an investigational new drug (IND) application for the molecule in October 2024, the company previously announced.2
“ENV-294 has the potential to redefine asthma treatment by targeting key pathways involved in airway inflammation via a non-steroidal, orally delivered therapeutic,” Viswa Colluru, PhD, CEO, and founder of Enveda said in the February 5 news release.1 “A major new asthma drug has not been approved in over a decade, highlighting the critical need for new treatments like ENV-294 to address unmet patient needs.”1
Enveda advanced ENV-294 to phase 1 trials in healthy subjects in the fourth quarter of 2024 with the goal of treating atopic dermatitis. The molecule had previously demonstrated strong efficacy in multiple preclinical studies coinciding with “robust safety margins” in qualifying studies for the IND, the company said. With results in hand from promising preclinical studies and translational data from animal models, Enveda scientists identified asthma as a “high-impact follow-on indication” for ENV-294.1 It 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 company said in an earlier news release.2
In the announcement of the addition of asthma research to the ENV-294 pipeline, the company also introduced an advisory board of world-renowned pulmonologists and asthma researchers that will support the novel agent’s development. Michael Wechsler, MD, professor of medicine and director of the asthma program at National Jewish Health in Denver, CO, will be the advisory board chair, according to Enveda.
Looking at the first potential targets for the novel therapy, Enveda emphasized the wide prevalence of atopic dermatitis in the US, which affects more than 10% of the population, according to the National Eczema Association. Existing treatment for eczema, however, relies on injectables that pose a significant barrier to patient adoption or oral therapies that come with significant potential toxicities, the company observed. “Enveda’s novel approach using a naturally derived drug molecule holds great promise for the treatment of AD,” Jonathan Silverberg, MD, PHD, MPH Professor and Director of Clinical Research, George Washington University School of Medicine and Health Sciences, said in a statement. (November)
Enveda integrates mass spectrometry with machine learning to accelerate natural product identification tapping the company’s searchable library that exceeds 1.5 million compounds, according to the website. The platform-driven approach advances lead compounds to development candidate status at a rate 4 times faster than industry standards. The ability to mobilize naturally existing molecular diversity through computational and analytical methodologies will enhance natural product drug discovery to address unmet clinical needs.
