ENV-294 / Enveda Biosci - LARVOL DELTA

A Previously Undrugged Target in Immune Therapeutics: Oral ENV-294 Provides First Clinical and Molecular Proof of Concept for RAC2 Modulation in Atopic Dermatitis (EADV 2026) - No abstract available

Clinical • Late-breaking abstract • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • RAC2

ENV-294, a First-in-Class Oral Rac2 Modulator, Demonstrates Deep, Durable Efficacy with a Favorable Safety Profile in Moderate-to-Severe Atopic Dermatitis: Results from a Phase 1b Open-Label Study (EADV 2026) - No abstract available

Clinical • P1 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • RAC2

A Phase 2b Dose-Ranging Study to Evaluate the Efficacy and Safety of ENV-294 in Adults With Moderate-to-Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Enveda Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Enveda’s Positive Phase 1B Results for ENV-294, a Potential First-in-Class Oral Therapy for Moderate-to-Severe Atopic Dermatitis, Were Presented at AAD Innovation Academy; Additional Details to Be Shared at EADV (Businesswire) - "On the exploratory endpoints in this trial, 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 nine 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....The company’s abstract on ENV-294 has been accepted for an oral presentation at the EADV Congress 2026 in Vienna, Austria, on Thursday, October 1, 2026. Enveda plans to present additional data from the ENV-294 program at the congress."

P1 data • Atopic Dermatitis

A Phase 2b Dose-Ranging Study to Evaluate the Efficacy and Safety of ENV-294 in Adults With Moderate-to-Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: Enveda Therapeutics

New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Study of ENV-294 in Healthy Adults and in Adults With Moderate-to-Severe Atopic Dermatitis (clinicaltrials.gov) - P1 | N=9 | Completed | Sponsor: Enveda Therapeutics | Active, not recruiting ➔ Completed | N=16 ➔ 9

Enrollment change • Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Study of ENV-294 in Healthy Adults and in Adults With Moderate-to-Severe Atopic Dermatitis (clinicaltrials.gov) - P1 | N=16 | Active, not recruiting | Sponsor: Enveda Therapeutics

New P1 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

ENV-294 for Moderate-to-Severe Asthma: A 12-Week Study in Adults (clinicaltrials.gov) - P2 | N=50 | Not yet recruiting | Sponsor: Enveda Therapeutics

New P2 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

ENV-294 for Moderate-to-Severe Asthma: A 12-Week Study in Adults (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Enveda Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Study of ENV-294 in Adults With Moderate-to-Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=64 | Recruiting | Sponsor: Enveda Therapeutics

New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Enveda…announced that it has initiated two parallel Phase 2a clinical trials evaluating ENV-294, a first-in-class oral small molecule, for the treatment of moderate-to-severe Atopic Dermatitis (AD) and Asthma (Businesswire) - "The Phase 2a program is designed to evaluate the safety, tolerability, and efficacy of ENV-294 in two distinct patient populations, supporting the Company’s strategy to develop ENV-294 as a 'pipeline-in-a-product' for inflammatory diseases....Enveda plans to initiate a Phase 2b study in 2026."

New P2 trial • Asthma • Atopic Dermatitis • Immunology

Phase 1b Interim Analysis (Businesswire) - "In the interim analysis, ENV-294 demonstrated a rapid onset of action, with robust EASI improvements consistent with an anticipated JAK-inhibitor-like efficacy profile in patients with moderate-to-severe AD. Importantly, ENV-294 also maintained the expected biologic-like favorable safety profile consistent with earlier Phase 1a healthy volunteer studies and 3-month GLP toxicology studies."

P1 data • Atopic Dermatitis

Enveda Reports Favorable Phase 1 Safety for Novel Oral Anti-Inflammatory, Launches Phase 1b Trial in Atopic Dermatitis (Businesswire) - "Enveda...announced the successful completion of its Phase 1 clinical trial of ENV-294, a novel oral therapeutic for atopic dermatitis, asthma, and beyond...ENV-294 was found to be well-tolerated with a favorable safety profile across all dose levels, with no dose-limiting toxicities or serious adverse events reported. Pharmacokinetic data demonstrated dose-proportional exposure and support the potential for once-daily oral dosing. The Phase 1b trial is designed to evaluate the safety, tolerability, pharmacokinetics, target engagement, and early signs of efficacy of ENV-294 in patients with moderate to severe atopic dermatitis. Phase 1b initiation is currently expected to begin in the second half of 2025."

P1 data • Trial status • Asthma • Atopic Dermatitis

Enveda Biosciences Named One of Biotech’s Most Promising Startups by Endpoints News (Businesswire) - "Enveda’s platform and library has already yielded four development candidates, with three additional candidates in fast follow. The two lead compounds both target inflammation. The first addresses inflammatory bowel disease through a novel MOA and biodistribution. The second, addressing atopic dermatitis, inhibits neutrophil migration through a unique MOA, blocking multiple chemoattractant pathways with a single molecule. Both of these compounds are slated to enter clinical trials in 2024."

New trial • Atopic Dermatitis • Immunology • Inflammatory Bowel Disease