- First-in-class, oral, once-daily therapy demonstrating robust efficacy with a favorable safety profile
- Rapid and deep clinical responses, with a mean EASI reduction of 85% at Day 42, and responses observed as early as Day 8
- 100% of patients achieved EASI-50, 78% achieved EASI-75, and 56% reached EASI-90, with continued improvement after treatment cessation
- Biomarker and mechanistic data support anticipated pan-endotype efficacy
- Favorable safety profile with no serious or severe adverse events and no patient discontinuations
- Evercore ISI analyst Umer Raffat to host webcast to discuss results on Wednesday, April 1, 2026 at 2:00 PM ET
BOULDER, Colo.--(BUSINESS WIRE)--Enveda, a clinical-stage biotech company developing first-in-class small-molecules derived from life’s chemistry, today announced positive Phase 1b results for ENV-294, a first-in-class, oral, once-daily investigational therapy, in patients with moderate-to-severe atopic dermatitis (AD).
The open-label study enrolled nine adults with moderate-to-severe atopic dermatitis, including patients with prior systemic therapy exposure, irrespective of their response to those treatments. Patients received oral ENV-294 of 800 mg (the highest dose tested in the Phase 1a study) once daily for 28 days, followed by a 14-day off-treatment observation period.
“ENV-294 is a first-in-class molecule enabled by Enveda’s chemistry-first approach, designed to access entirely new biology,” said Viswa Colluru, Ph.D., Founder and CEO, Enveda. “Rather than suppressing individual cytokines, it is a non-degrading molecular glue, or ‘LOCKTAC,’ that resets the cellular immune response to chronic inflammation. We are advancing ENV-294 into Phase 2a trials in atopic dermatitis and asthma, with a Phase 2b study planned for mid-2026. Alongside additional clinical programs in IBD and obesity, ENV-294 represents the first-in-class innovation that could alter the treatment landscape and make a meaningful difference to the patient journey.”
In the Phase 1b study, ENV-294 demonstrated rapid, deep, and durable clinical responses. Patients achieved a mean 68% reduction in Eczema Area and Severity Index (EASI) scores by Day 28, which deepened to 85% by Day 42, 14 days after treatment cessation. All patients achieved EASI-50 at Day 42, with 78% reaching EASI-75 and 56% achieving EASI-90. In addition, 44% of patients achieved a vIGA-AD score of 0 or 1, including two patients with complete skin clearance (vIGA-AD score of 0) by Day 42. Further, one of these patients with complete skin clearance was a confirmed non-responder to the IL4R pathway biologic therapy. Responses were observed as early as Day 8 and continued to improve after treatment ended, suggesting the potential for durable disease modification.
The study also reported meaningful improvements in total itch from baseline, as measured by PP-NRS (Peak Pruritus NRS) and SCORAD (Scoring Atopic Dermatitis), consistent with lesion improvement in patients. Serum and skin biomarker data from the Phase 1b trial reported consistent, multi-modal evidence of on-target engagement and modulation of multiple disease pathways. The data support a model in which ENV-294 drives a pan-endotype treatment response by reconfiguring cellular immunity to chronic inflammation, rather than the single-axis cytokine blockade employed by current therapies. This mechanistic framework is consistent with the depth and breadth of clinical efficacy.
ENV-294 was well tolerated, with no serious or severe adverse events reported and no treatment-related adverse events or discontinuations. No clinically meaningful changes were observed in laboratory parameters, vital signs, or ECGs, and the therapy showed no safety signals typically associated with existing systemic treatments, including those linked to immunosuppression.
“The atopic dermatitis treatment landscape has advanced with biologics and JAK inhibitors, but no oral therapy today delivers JAK-inhibitor-like efficacy without boxed warnings and laboratory monitoring,” said Jonathan Silverberg, M.D., Ph.D., Professor of Dermatology at The George Washington University School of Medicine and Health Sciences. “The ENV-294 data, while early, are compelling, with rapid, deep responses by Day 28 that continue to improve after treatment cessation. The biomarker profile also indicates broad activity across Th2, Th17, and Th1 pathways, which is particularly relevant in many atopic dermatitis patients with mixed or non–Th2-driven disease. If confirmed in larger studies, ENV-294 could represent a meaningful advance in the treatment of atopic dermatitis.”
“As a lead investigator, what struck me was how well patients tolerated ENV-294 with no serious or severe adverse events, no discontinuations, and a safety profile distinct from what we typically see with systemic immunosuppressants or JAK inhibitors. Equally impressive was the clinical response, with 56% achieving EASI-90 and 44% of patients achieving complete or near-complete skin clearance by Day 42. For patients living with moderate-to-severe atopic dermatitis, the combination of a rapid, deep response in a well-tolerated, once-daily oral therapy is encouraging. These results give me genuine confidence that ENV-294 warrants further investigation in larger trials,” said Leon Kircik, M.D., Clinical Professor at Mount Sinai.
Webcast Information
Evercore ISI analyst Umer Raffat will host a live webcast with Viswa Colluru, Enveda’s Founder & CEO, on Wednesday, April 1, 2026, at 2:00 PM ET.
About Enveda
Enveda is a biotechnology company that learns from life’s chemistry to create better medicines faster. Enveda uses AI-powered tools to identify and characterize a wide range of molecules produced by living organisms, the vast majority of which have never been explored by science, creating a database of chemical biodiversity: the library of life. By growing, organizing, translating, and searching this unique library, Enveda learns from life’s evolved solutions to address today’s most pressing medical needs. For more information, visit enveda.com.
Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding the potential therapeutic benefits of ENV-294 and the anticipated milestones for our clinical programs. These statements are based on management’s current expectations and are subject to substantial risks and uncertainties that could cause actual results to differ materially. These risks include the inherent uncertainties of clinical development, the risk that preclinical data may not predict clinical results, and regulatory review processes. ENV-294 is an investigational agent and is not approved for use by any regulatory authority. Enveda undertakes no obligation to update these statements.
Contacts
Investor Contact:
Soumoditya Dey
VP, Corporate Development and Investor Relations
soumoditya.dey@enveda.com
Media Contact:
KKH Advisors
Kimberly Ha
kimberly.ha@kkhadvisors.com
917-291-5744
